Trial Outcomes & Findings for Effect of Diaphragm Stimulation During Surgery (NCT NCT03303040)
NCT ID: NCT03303040
Last Updated: 2024-06-26
Results Overview
High-resolution respirometry will be used to assess mitochondrial respiration of permeablilized diaphragm bundles. Addition of substrate medium to the Oroboros O2K respirometry instrument enables quantification of leak respiration and peak uncoupled respiration, expressed as pmol oxygen/sec/mg wet weight.
COMPLETED
NA
25 participants
Up to eight hours
2024-06-26
Participant Flow
Participant milestones
| Measure |
Participants Undergoing Elective, Open Cardiothoracic Surgical Procedures Lasting 4 Hours or Greater
Patients undergoing complex, elective prolonged surgeries, usually lasting 5-8 hours or longer, including lung transplants (e.g. valvuloplasty, coronary artery bypass and/or aortic repairs)
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Diaphragm Stimulation During Surgery
Baseline characteristics by cohort
| Measure |
Participants Undergoing Elective, Open Cardiothoracic Surgical Procedures Lasting 4 Hours or Greater
n=21 Participants
Patients undergoing complex, elective prolonged surgeries, usually lasting 5-8 hours or longer, including lung transplants (e.g. valvuloplasty, coronary artery bypass and/or aortic repairs)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=39 Participants
|
|
Age, Continuous
|
59 Number
STANDARD_DEVIATION 11.4 • n=39 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=39 Participants
|
|
Number of stimulations
|
6.2 Number of Stimulations
STANDARD_DEVIATION 1.9 • n=39 Participants
|
|
Stimulation Current Intensity
|
18.0 mA
STANDARD_DEVIATION 5.4 • n=39 Participants
|
|
%Force Vital Capacity
|
86.6 Percentage of predicted value
STANDARD_DEVIATION 14.4 • n=39 Participants
|
|
% Forced Expiratory Volume
|
83.2 Percentage of predicted
STANDARD_DEVIATION 15.0 • n=39 Participants
|
|
Maximal Inspiratory Pressure
|
90.6 cm H2O
STANDARD_DEVIATION 23.0 • n=39 Participants
|
|
Body Mass Index
|
29.8 Kg/m^2
STANDARD_DEVIATION 3.96 • n=39 Participants
|
|
Intubation to Biopsy
|
278 Minutes
STANDARD_DEVIATION 65 • n=39 Participants
|
|
Intubation to Frist Stimulation
|
98 Minute
STANDARD_DEVIATION 33 • n=39 Participants
|
|
Cardiopulmonary Bypass
|
137 Minutes
STANDARD_DEVIATION 65 • n=39 Participants
|
|
Minimum Core Temperature
|
33.5 Degrees Celsius
STANDARD_DEVIATION 2.4 • n=39 Participants
|
|
Core Temperature at Biopsy
|
36.5 Degrees Celsius
STANDARD_DEVIATION 0.8 • n=39 Participants
|
PRIMARY outcome
Timeframe: Up to eight hoursPopulation: Mitochondrial respiration was measured in the stimulated (n=19) and unstimulated (n=19) hemidiaphragms from subjects who completed the entire intra-operative stimulation protocol. Biopsy tissue was specifically reserved for analysis. From the full patient sample, insufficient contractile tissue was available to measure mitochondrial respiration in two unstimulated and two stimulated hemidiaphragms.
High-resolution respirometry will be used to assess mitochondrial respiration of permeablilized diaphragm bundles. Addition of substrate medium to the Oroboros O2K respirometry instrument enables quantification of leak respiration and peak uncoupled respiration, expressed as pmol oxygen/sec/mg wet weight.
Outcome measures
| Measure |
Control
n=19 Participants
No stimulation of hemidiaphragm
|
Stimulation
n=19 Participants
Electrical stimulation of hemidiaphragm
|
|---|---|---|
|
Mitochondrial Respiration
Leak Respiration
|
3.5 pmol/s/mg wwt
Standard Deviation 0.7
|
2.9 pmol/s/mg wwt
Standard Deviation 0.6
|
|
Mitochondrial Respiration
ECI+II
|
31.1 pmol/s/mg wwt
Standard Deviation 3.5
|
27.1 pmol/s/mg wwt
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Up to eight hoursPopulation: Aconitase activity was measured in the stimulated (n=20) and unstimulated (n=18) hemidiaphragms from subjects who completed the entire intra-operative stimulation protocol. Insufficient tissue was available in two unstimulated hemidiaphragms. Tissue obtained from one participant contained large proportions of intramuscular fat that prevented a measurement.
In order to evaluate mitochondrial damage, actonitase activity will be measured spectrophotometrically. It will be quantified as units/mg protein.
Outcome measures
| Measure |
Control
n=20 Participants
No stimulation of hemidiaphragm
|
Stimulation
n=18 Participants
Electrical stimulation of hemidiaphragm
|
|---|---|---|
|
Aconitase Activity
|
0.175 mU/mg protein
Standard Deviation 0.01
|
0.196 mU/mg protein
Standard Deviation 0.01
|
PRIMARY outcome
Timeframe: Up to eight hoursPopulation: Protein content was measured by traditional Western blot. Samples were analyzed from the stimulated and unstimulated hemidiaphragms of the first 11 participants. Protein quantification was normalized to total protein and optical density units of the stimulated and unstimulated hemidiaphragm were reported.
Lipid peroxidation will be assessed by measuring 4-hydroxy-2-nonenal-modified proteins. It will be quantified as arbitrary optical density units.
Outcome measures
| Measure |
Control
n=11 Participants
No stimulation of hemidiaphragm
|
Stimulation
n=11 Participants
Electrical stimulation of hemidiaphragm
|
|---|---|---|
|
Lipid Peroxidation
|
1.037 Arbitrary optical density units (U)
Standard Deviation 0.145
|
1.061 Arbitrary optical density units (U)
Standard Deviation 0.134
|
PRIMARY outcome
Timeframe: Up to eight hoursPopulation: Citrate synthase activity was measured in the stimulated (n=20) and unstimulated (n=18) hemidiaphragms from subjects who completed the entire intra-operative stimulation protocol. Insufficient tissue was available in two unstimulated hemidiaphragms. Tissue obtained from one participant contained large proportions of intramuscular fat that prevented a measurement.
Changes in electron transport chain will be assessed by measuring citrate cynthase activity. It will be quantified as nmol/mg protein/min.
Outcome measures
| Measure |
Control
n=18 Participants
No stimulation of hemidiaphragm
|
Stimulation
n=20 Participants
Electrical stimulation of hemidiaphragm
|
|---|---|---|
|
Citrate Cynthase Activity
|
0.084 nmol/mg protein/min
Standard Deviation 0.006
|
0.082 nmol/mg protein/min
Standard Deviation 0.004
|
PRIMARY outcome
Timeframe: Up to eight hoursPopulation: Specific force represents force generation per cross sectional area of single diaphragm fibers and was calculated from an average of 10 slow and 10 fast single fibers obtained from each hemidiaphragm, per subject. Of the 21 patients who completed intraoperative stimulation procedures, single fiber measurements were not obtained in two participants due to unavailability of study personnel (n=2) and non-cardiac surgery (n=1).
Specific force of single diaphragm fibers represents the force generated per unit area.
Outcome measures
| Measure |
Control
n=372 Muscle Fibers
No stimulation of hemidiaphragm
|
Stimulation
n=373 Muscle Fibers
Electrical stimulation of hemidiaphragm
|
|---|---|---|
|
Single Diaphragm Fiber, Specific Force
Fast Fibers
|
124.5 kN/m2
Standard Error 2.39
|
126.93 kN/m2
Standard Error 4.3
|
|
Single Diaphragm Fiber, Specific Force
Slow Fibers
|
102.64 kN/m2
Standard Error 2.38
|
95.85 kN/m2
Standard Error 4.62
|
PRIMARY outcome
Timeframe: Up to eight hoursPopulation: Rate constant of tension development (ktr) represents the half-time of force recovery after release of a standardized stretch. ktr was calculated from an average of 10 slow and 10 fast single fibers obtained from each hemidiaphragm, per subject. Of the 21 patients who completed intraoperative stimulation procedures, single fiber measurements were not obtained in two participants due to unavailability of study personnel (n=2) and non-cardiac surgery (n=1).
Single diaphragm fiber mechanical force properties will be measured. The rate of tension redevelopment is quantified as s\^(-1).
Outcome measures
| Measure |
Control
n=372 Muscle Fibers
No stimulation of hemidiaphragm
|
Stimulation
n=373 Muscle Fibers
Electrical stimulation of hemidiaphragm
|
|---|---|---|
|
Single Diaphragm Fiber, Rate of Tension Redevelopment
Slow Fibers
|
1.102 per second (force recovery rate)
Standard Error 0.269
|
1.143 per second (force recovery rate)
Standard Error 0.236
|
|
Single Diaphragm Fiber, Rate of Tension Redevelopment
Fast Fibers
|
4.744 per second (force recovery rate)
Standard Error 1.322
|
4.777 per second (force recovery rate)
Standard Error 1.369
|
PRIMARY outcome
Timeframe: Up to eight hoursPopulation: pCa50 represents the sensitivity of pCa (concentration of Ca+2: -log10\[Ca+2\]) at which half-maximal force generation was obtained. It was calculated from an average of 10 slow and 10 fast single fibers obtained from each hemidiaphragm, per subject. Of the 21 patients who completed intraoperative stimulation procedures, single fiber measurements were not obtained in two participants due to unavailability of study personnel (n=2) and non-cardiac surgery (n=1).
The pCa50 value is the logarithmic scale of pCa (sensitivity of Ca+2) at which half-maximal force generation was obtained. The pCa value is calculated as the -log10\[Ca (nm)\]; the pCa50 is the -log10\[Ca (nm)\] at which half-maximal force is generated.
Outcome measures
| Measure |
Control
n=372 Muscle Fibers
No stimulation of hemidiaphragm
|
Stimulation
n=373 Muscle Fibers
Electrical stimulation of hemidiaphragm
|
|---|---|---|
|
Calcium Sensitivity (pCa50)
Slow Muscle Fibers
|
5.805 -log10[Ca2+]
Standard Error 0.158
|
5.797 -log10[Ca2+]
Standard Error 0.161
|
|
Calcium Sensitivity (pCa50)
Fast Muscle Fibers
|
5.888 -log10[Ca2+]
Standard Error 0.115
|
5.887 -log10[Ca2+]
Standard Error 0.121
|
PRIMARY outcome
Timeframe: Up to eight hoursPopulation: The quantities of total titin protein and myosin heavy chain protein content in homogenized diaphragm fiber specimens were measured and then calculated as a ratio of total titin to myosin heavy chain content. The statistical approach selected to test the effect of stimulation on titin:myosin heavy chain ratio was selected apriori as the difference between the stimulated and unstimulated sides.
The quantities of total titin protein and myosin heavy chain protein content in homogenized diaphragm fiber specimens were measured and then calculated as a ratio of total titin to myosin heavy chain content (unitless value). The statistical approach was selected apriori as the difference of the ratio between the stimulated and unstimulated sides.
Outcome measures
| Measure |
Control
n=11 Participants
No stimulation of hemidiaphragm
|
Stimulation
n=11 Participants
Electrical stimulation of hemidiaphragm
|
|---|---|---|
|
Difference in Total Titin to Myosin Heavy Chain Ratio
|
0.111 Total titan/MHC Ratio
Standard Deviation 0.042
|
0.103 Total titan/MHC Ratio
Standard Deviation 0.044
|
PRIMARY outcome
Timeframe: Up to eight hoursPopulation: The composition of the N2A and tT2 exons of the titin protein was obtained from homogenized tissue of the unstimulated and stimulated hemidiaphragms of the first 11 subjects. The relative abundance of each exon was calculated as a percentage of total titin.
The composition of titin exons will be assessed and quantified via real-time polymerase chain reaction (qPCR). The N2A and tT2 will be calculated as a percentage of total titin.
Outcome measures
| Measure |
Control
n=11 Participants
No stimulation of hemidiaphragm
|
Stimulation
n=11 Participants
Electrical stimulation of hemidiaphragm
|
|---|---|---|
|
Difference in Titin Exon Composition
Percentage N2A
|
96.1 Percent of total titin
Standard Deviation 9.3
|
96.3 Percent of total titin
Standard Deviation 6.9
|
|
Difference in Titin Exon Composition
Percentage tT2
|
3.9 Percent of total titin
Standard Deviation 9.3
|
3.7 Percent of total titin
Standard Deviation 6.9
|
PRIMARY outcome
Timeframe: Up to eight hoursPopulation: Content of titin binding proteins including MARP1 (ANKRD-1) and MARP2 (ANKRD-2) were measured in homogenized tissue obtained from the stimulated and unstimulated hemidiaphragms of the first 11 subjects and quantified using western blot. The results were normalized to the optical intensity of GAPDH (AU).
The content of titin binding proteins will be quantified via Western blot. It will be normalized to a reference protein (GAPDH) and presented as optical intensity (AU).
Outcome measures
| Measure |
Control
n=11 Participants
No stimulation of hemidiaphragm
|
Stimulation
n=11 Participants
Electrical stimulation of hemidiaphragm
|
|---|---|---|
|
Difference in Titin Binding Protein Content
ANKRD1
|
0.0165 AU
Standard Deviation 0.0279
|
0.0167 AU
Standard Deviation 0.025
|
|
Difference in Titin Binding Protein Content
ANKRD2
|
1.39 AU
Standard Deviation 0.44
|
1.28 AU
Standard Deviation 0.52
|
PRIMARY outcome
Timeframe: Up to eight hoursPopulation: Calpain-1 (µ-calpain) protein content was measured by traditional Western blot. Samples were analyzed from the stimulated and unstimulated hemidiaphragms of the first 9 participants and normalized to total protein. The statistical approach selected to test the effect of stimulation on oxidative stress-related protein content was selected apriori as the difference between the stimulated and unstimulated sides. Full-length (80kDa) and truncated (76 kDa) isoforms are reported.
Calpain 1 (mu-calpain) will be measured with Western Blot analysis and will be presented as percent of total intensity in stimulated and unstimulated hemidiaphragms
Outcome measures
| Measure |
Control
n=11 Participants
No stimulation of hemidiaphragm
|
Stimulation
n=11 Participants
Electrical stimulation of hemidiaphragm
|
|---|---|---|
|
Difference in Calpain 1 Protein Content
Full length (80 kDa) CLP1 isoform
|
74 Percent of total Intensity
Standard Deviation 5.4
|
72.4 Percent of total Intensity
Standard Deviation 5.4
|
|
Difference in Calpain 1 Protein Content
Truncated (76 kDa) CLP1 isoform
|
14.1 Percent of total Intensity
Standard Deviation 2.6
|
15 Percent of total Intensity
Standard Deviation 3
|
PRIMARY outcome
Timeframe: Up to eight hoursPopulation: Protein content of AKT, p-AKT, calpain-2, calpain-3, caspase-3, atrogin-1 was measured by automated, capillary-based immunoassay using a Jess System. Samples were analyzed from the stimulated and unstimulated hemidiaphragms of the first 9 participants and normalized to total protein.
Calpain 2 will be measured with automated, capillary-based immunoassay using a Jess System, normalized to total protein, and will be presented as an area of corrected peak (AU) in stimulated and unstimulated hemidiaphragms.
Outcome measures
| Measure |
Control
n=11 Participants
No stimulation of hemidiaphragm
|
Stimulation
n=11 Participants
Electrical stimulation of hemidiaphragm
|
|---|---|---|
|
Difference in Calpain 2 Protein Content
|
274938 AU
Standard Deviation 118636
|
357182 AU
Standard Deviation 219400
|
PRIMARY outcome
Timeframe: Up to eight hoursPopulation: Protein content of AKT, p-AKT, calpain-2, calpain-3, caspase-3, atrogin-1 was measured by automated, capillary-based immunoassay using a Jess System. Samples were analyzed from the stimulated and unstimulated hemidiaphragms of the first 9 participants and normalized to total protein. The statistical approach selected to test the effect of stimulation on oxidative stress-related protein was selected apriori as the difference between the stimulated and unstimulated sides.
Calpain 3 will be measured with Western Blot analysis and will be presented as a ratio of cleaved to total calpain 3 (unitless value) in stimulated and unstimulated hemidiaphragms.
Outcome measures
| Measure |
Control
n=11 Participants
No stimulation of hemidiaphragm
|
Stimulation
n=11 Participants
Electrical stimulation of hemidiaphragm
|
|---|---|---|
|
Difference in Calpain 3 Protein Content
|
2.98 ratio of cleaved/total calpain 3
Standard Deviation 1.35
|
3.21 ratio of cleaved/total calpain 3
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: Up to eight hoursPopulation: Protein content of calpain-2, calpain-3, caspase-3, atrogin-1 was measured by automated, capillary-based immunoassay using a Jess System. Samples were analyzed from the stimulated and unstimulated hemidiaphragms of the first 9 participants and normalized to total protein.
Caspase-3 will be measured with Western Blot analysis, normalized to total protein loaded in each lane, and will be presented as an area of corrected peak (AU) in stimulated and unstimulated hemidiaphragm muscle fibers.
Outcome measures
| Measure |
Control
n=11 Participants
No stimulation of hemidiaphragm
|
Stimulation
n=11 Participants
Electrical stimulation of hemidiaphragm
|
|---|---|---|
|
Difference in Caspase-3 Protein Content
|
274328 AU
Standard Deviation 70600
|
317726 AU
Standard Deviation 164524
|
PRIMARY outcome
Timeframe: Up to eight hoursPopulation: Protein content of AKT, p-AKT, calpain-2, calpain-3, caspase-3, atrogin-1 was measured by automated, capillary-based immunoassay using a Jess System. Samples were analyzed from the stimulated and unstimulated hemidiaphragms of the first 9 participants and normalized to total protein.
Atrogin 1 will be measured with Jess protein immunoassay analysis, normalized to total protein, and will be presented as the corrected peak area (AU) in stimulated and unstimulated hemidiaphragm muscle fibers.
Outcome measures
| Measure |
Control
n=11 Participants
No stimulation of hemidiaphragm
|
Stimulation
n=11 Participants
Electrical stimulation of hemidiaphragm
|
|---|---|---|
|
Atrogin 1
|
634046 AU
Standard Deviation 377885
|
675965 AU
Standard Deviation 379914
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to eight hoursPopulation: Limited tissue quantity did not permit analysis.
Mitochondrial reactive oxygen species (ROS) production will be assessed using an in situ approach to measure hydrogen peroxide production in permeabilized diaphragm skeletal muscle fiber bundles. It will be quantified as pmol/min/mg dry weight.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to eight hoursPopulation: Limited tissue quantity did not permit analysis.
Changes in electron transport chain will be assessed by measuring cytochrome c oxidase (COX) activity. It will be quantifed as Units/mcg protein.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to eight hoursPopulation: Limited tissue quantity did not permit analysis.
Long-Amplicon quantitative PCR will be used to measure the frequency of nuclear DNA mutations. It will be quantified as number of lesions/10 kilobases.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to eight hoursPopulation: Limited tissue quantity did not permit analysis.
Titin integrity will be assessed. A relative titin size will be quantified in nm.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to eight hoursPopulation: Changes in Caspase-9 protein were not evaluated due to lack of a reliable antibody with preparatory validation studies.
Caspase-9 will be measured with Western Blot anaylsis and will be presented as percent difference in expression.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to eight hoursPopulation: Changes in 20S proteasome protein were not evaluated due to lack of a reliable antibody with preparatory validation studies.
20S proteasome will be measured with Western Blot anaylsis and will be presented as percent difference in expression.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to eight hoursPopulation: Changes in 26S Proteasome protein were not evaluated due to lack of a reliable antibody with preparatory validation studies.
26S proteasome will be measured with Western Blot anaylsis and will be presented as percent difference in expression.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to eight hoursPopulation: Differences in 28SrRNA were not completed due to challenges with cross-species validation of reagents and reference values.
28SrRNA will be measured with Western Blot anaylsis and will be presented as percent difference in expression.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to eight hoursPopulation: Differences in 18SrRNA were not completed due to challenges with cross-species validation of reagents and reference values.
18SrRNA will be measured with Western Blot anaylsis and will be presented as percent difference in expression.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to eight hoursPopulation: Changes in Foxo-3 protein were not evaluated due to lack of a reliable antibody with preparatory validation studies.
Foxo-3 will be measured with Western Blot anaylsis and will be presented as percent difference in expression.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to eight hoursPopulation: Changes in 45S pre-rRNA protein were not evaluated due to lack of a reliable antibody with preparatory validation studies.
45S pre-rRNA will be measured with Western Blot anaylsis and will be presented as percent difference in expression.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to eight hoursPopulation: Limited tissue quantity did not permit analysis.
Long-Amplicon quantitative PCR will be used to measure the frequency of mitochondrial DNA mutations. It will be quantified as number of lesions/10 kilobases.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to eight hoursPopulation: Changes in MuRF1 protein were not evaluated due to lack of a reliable antibody with preparatory validation studies.
MurF1 will be measured with Western Blot anaylsis and will be presented as percent difference in expression.
Outcome measures
Outcome data not reported
Adverse Events
Participants Undergoing Elective, Open Cardiothoracic Surgical Procedures Lasting 4 Hours or Greater
Serious adverse events
| Measure |
Participants Undergoing Elective, Open Cardiothoracic Surgical Procedures Lasting 4 Hours or Greater
n=21 participants at risk
Patients undergoing complex, elective prolonged surgeries, usually lasting 5-8 hours or longer, including lung transplants (e.g. valvuloplasty, coronary artery bypass and/or aortic repairs)
|
|---|---|
|
Cardiac disorders
Arrhythmias
|
47.6%
10/21 • Number of events 11 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
3/21 • Number of events 4 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
General disorders
Dysphagia
|
14.3%
3/21 • Number of events 3 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
9.5%
2/21 • Number of events 2 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Infections and infestations
Methycillin sensitive staph aureus infection
|
9.5%
2/21 • Number of events 2 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
4.8%
1/21 • Number of events 1 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory insufficiency
|
4.8%
1/21 • Number of events 1 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Cardiac disorders
Near-syncope
|
4.8%
1/21 • Number of events 1 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Cardiac disorders
Low cardiac index
|
4.8%
1/21 • Number of events 1 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Infections and infestations
Sternal wound infection
|
4.8%
1/21 • Number of events 1 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Cardiac disorders
Tachycardia
|
4.8%
1/21 • Number of events 1 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Vascular disorders
Acute MCA stroke
|
4.8%
1/21 • Number of events 1 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Vascular disorders
Pulmonary embolism
|
4.8%
1/21 • Number of events 1 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
4.8%
1/21 • Number of events 1 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Musculoskeletal and connective tissue disorders
Sternal malunion
|
4.8%
1/21 • Number of events 1 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Infections and infestations
Cellulitis
|
4.8%
1/21 • Number of events 1 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
Other adverse events
| Measure |
Participants Undergoing Elective, Open Cardiothoracic Surgical Procedures Lasting 4 Hours or Greater
n=21 participants at risk
Patients undergoing complex, elective prolonged surgeries, usually lasting 5-8 hours or longer, including lung transplants (e.g. valvuloplasty, coronary artery bypass and/or aortic repairs)
|
|---|---|
|
General disorders
Postoperative Pain
|
95.2%
20/21 • Number of events 20 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Blood and lymphatic system disorders
Anemia
|
81.0%
17/21 • Number of events 17 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
47.6%
10/21 • Number of events 10 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
47.6%
10/21 • Number of events 10 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
42.9%
9/21 • Number of events 9 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
28.6%
6/21 • Number of events 6 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Renal and urinary disorders
Acute kidney injury
|
19.0%
4/21 • Number of events 4 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Vascular disorders
Hypotension
|
19.0%
4/21 • Number of events 4 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Cardiac disorders
Bradycardia
|
19.0%
4/21 • Number of events 4 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
3/21 • Number of events 4 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Cardiac disorders
Pericardial effusion
|
9.5%
2/21 • Number of events 2 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
9.5%
2/21 • Number of events 2 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
9.5%
2/21 • Number of events 2 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
|
Blood and lymphatic system disorders
Bilateral lower extremity edema
|
9.5%
2/21 • Number of events 2 • From enrollment of each patient until their hospital discharge, which was typically within 7-10 days post-op.
Standard CT.gov definitions were used, and assessments were conducted systematically through the medical record and consultation with the study surgeons.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place