Trial Outcomes & Findings for Pilot Testing a Home-Based Rehabilitation Intervention Designed to Improve Outcomes of Frail Veterans Following Cardiothoracic Surgery (NCT NCT03299101)
NCT ID: NCT03299101
Last Updated: 2021-01-13
Results Overview
Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Baseline
Results posted on
2021-01-13
Participant Flow
Participant milestones
| Measure |
Prehabilitation
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
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Overall Study
STARTED
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35
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Overall Study
COMPLETED
|
25
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Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Prehabilitation
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
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Overall Study
Lost to Follow-up
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1
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Overall Study
Withdrawal by Subject
|
5
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Overall Study
Surgery was changed
|
3
|
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Overall Study
Not enough time to complete prehab
|
1
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Baseline Characteristics
Pilot Testing a Home-Based Rehabilitation Intervention Designed to Improve Outcomes of Frail Veterans Following Cardiothoracic Surgery
Baseline characteristics by cohort
| Measure |
Prehabilitation
n=33 Participants
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
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11 Participants
n=99 Participants
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Age, Categorical
>=65 years
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22 Participants
n=99 Participants
|
|
Age, Continuous
|
66.09 years
STANDARD_DEVIATION 7.66 • n=99 Participants
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Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
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Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
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33 Participants
n=99 Participants
|
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Risk Analysis Index
|
17.85 Score on a scale
STANDARD_DEVIATION 8.92 • n=99 Participants
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PRIMARY outcome
Timeframe: BaselinePopulation: 65 is the number of patients approached.
Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.
Outcome measures
| Measure |
Prehabilitation
n=65 Participants
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
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Recruitment Rate
|
35 Participants
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PRIMARY outcome
Timeframe: 90 days postoperativelyRetention rate will be expressed as the percentage of enrolled patients who were retained in the study and completed study procedures. It will be calculated for incremental steps along the study timeline and at the completion of study procedures 90 days postoperatively.
Outcome measures
| Measure |
Prehabilitation
n=35 Participants
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
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Retention Rate
|
25 Participants
|
PRIMARY outcome
Timeframe: Day of surgeryPopulation: All participants that self-reported their home training and/or showed their exercise or nutrition logs were analyzed.
Compliance rates will be expressed as the percentage of assigned activities actually completed by patients as recorded in home exercise and nutrition logs.
Outcome measures
| Measure |
Prehabilitation
n=27 Participants
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
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Adherence Rate
Home Strength/Aerobic/Transition Training
|
78.85 percentage of activities completed
Standard Deviation 28.96
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Adherence Rate
Home Breathing Training
|
86.30 percentage of activities completed
Standard Deviation 24.20
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Adherence Rate
Home Nutrition Log
|
64.09 percentage of activities completed
Standard Deviation 14.10
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SECONDARY outcome
Timeframe: Baseline, day of surgery, 90 days postoperativelyPopulation: All participants that completed the hand grip assessment were analyzed at each completed timepoint.
Grip strength will be measured in kilograms of pressure using a Smedley grip dynamometer
Outcome measures
| Measure |
Prehabilitation
n=33 Participants
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
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Change in Grip Strength Over the Course of Treatment and Recovery.
Baseline Grip Strength
|
31.52 kgf/cm2
Standard Deviation 9.27
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Change in Grip Strength Over the Course of Treatment and Recovery.
Day of Surgery Grip Strength
|
32.19 kgf/cm2
Standard Deviation 7.89
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Change in Grip Strength Over the Course of Treatment and Recovery.
90 Days Post Surgery
|
31.13 kgf/cm2
Standard Deviation 9.99
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SECONDARY outcome
Timeframe: Baseline, day of surgery, 90 days postoperativelyPopulation: All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.
Pulmonary function will be measured in terms of maximum MIP (maximal inspiratory pressure).
Outcome measures
| Measure |
Prehabilitation
n=33 Participants
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
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Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP
Baseline Max MIP
|
71.42 cm of H2O
Standard Deviation 24.54
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Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP
Day of surgery Max MIP
|
77.96 cm of H2O
Standard Deviation 24.23
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Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP
90 Day Postop Max MIP
|
79.82 cm of H2O
Standard Deviation 26.86
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SECONDARY outcome
Timeframe: Baseline, day of surgery, 90 days postoperativelyPopulation: All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.
Pulmonary function will be measured in terms of mean maximal inspiratory pressure (MIP).
Outcome measures
| Measure |
Prehabilitation
n=33 Participants
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
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Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MIP
Baseline Mean MIP
|
60.69 cm of H2O
Standard Deviation 23.57
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Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MIP
Day of surgery Mean MIP
|
69.38 cm of H2O
Standard Deviation 23.11
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Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MIP
90 Day Postop Mean MIP
|
71.43 cm of H2O
Standard Deviation 26.10
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SECONDARY outcome
Timeframe: Baseline, day of surgery, 90 days postoperativelyPopulation: All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.
Pulmonary function will be measured in terms of maximum MEP (maximal expiratory pressures)
Outcome measures
| Measure |
Prehabilitation
n=33 Participants
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
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Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MEP
Baseline Max MEP
|
108.09 cm of H2O
Standard Deviation 33.64
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Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MEP
Day of surgery Max MEP
|
120.81 cm of H2O
Standard Deviation 30.40
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Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MEP
90 Day Postop Max MEP
|
123.64 cm of H2O
Standard Deviation 32.64
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SECONDARY outcome
Timeframe: Baseline, day of surgery, 90 days postoperativelyPopulation: All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.
Pulmonary function will be measured in terms of mean maximal expiratory pressures (MEP).
Outcome measures
| Measure |
Prehabilitation
n=33 Participants
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
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Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MEP
Baseline Mean MEP
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98.48 cm of H2O
Standard Deviation 32.90
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Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MEP
Day of surgery Mean MEP
|
111.22 cm of H2O
Standard Deviation 28.62
|
|
Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MEP
90 Day Postop Mean MEP
|
112.01 cm of H2O
Standard Deviation 31.72
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SECONDARY outcome
Timeframe: Baseline, day of surgery, 90 days postoperativelyPopulation: All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.
Pulmonary function will be measured in terms of maximum sustained MIP (SMIP).
Outcome measures
| Measure |
Prehabilitation
n=33 Participants
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
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Change in Pulmonary Function Over the Course of Treatment and Recovery: Max SMIP
Baseline Max SMIP
|
416.55 cm of H2O
Standard Deviation 197.85
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Change in Pulmonary Function Over the Course of Treatment and Recovery: Max SMIP
Day of surgery Max SMIP
|
434.48 cm of H2O
Standard Deviation 192.42
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|
Change in Pulmonary Function Over the Course of Treatment and Recovery: Max SMIP
90 Day Postop Max SMIP
|
466.77 cm of H2O
Standard Deviation 197.27
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SECONDARY outcome
Timeframe: Baseline, day of surgery, 90 days postoperativelyPopulation: All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.
Pulmonary function will be measured in terms of mean sustained MIP (SMIP).
Outcome measures
| Measure |
Prehabilitation
n=33 Participants
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
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Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean SMIP
Day of surgery Mean SMIP
|
393.86 cm of H2O
Standard Deviation 185.85
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Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean SMIP
Baseline Mean SMIP
|
364.36 cm of H2O
Standard Deviation 171.33
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Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean SMIP
90 Day Postop Mean SMIP
|
435.94 cm of H2O
Standard Deviation 202.14
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SECONDARY outcome
Timeframe: Baseline, day of surgery, 90 days postoperativelyPopulation: All participants that completed the blood draw were analyzed at each completed timepoint. Additionally, there was an error in the lab when processing the blood samples, this caused many samples to be evaluated incorrectly. Only correctly analyzed labs were included in this analysis.
Higher levels indicate greater levels of protein. Lower levels indicate the potential of inflammation. normal range is 18-41, Below 18 is lower than normal, above 41 is higher than normal
Outcome measures
| Measure |
Prehabilitation
n=23 Participants
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
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Serum Prealbumin Over the Course of Treatment and Recovery
Baseline Serum Prealbumin
|
26.27 mg/dL
Standard Deviation 5.57
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Serum Prealbumin Over the Course of Treatment and Recovery
Day of surgery Serum Prealbumin
|
26.50 mg/dL
Standard Deviation 4.52
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Serum Prealbumin Over the Course of Treatment and Recovery
90 Day Postop Serum Prealbumin
|
25.13 mg/dL
Standard Deviation 6.48
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SECONDARY outcome
Timeframe: Baseline, day of surgery, 90 days postoperativelyPopulation: All participants that completed the gait speed assessment were analyzed at each completed timepoint.
Gait speed will be measured by using a stopwatch to time how long the patient takes to walk 4 meters
Outcome measures
| Measure |
Prehabilitation
n=33 Participants
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
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Change in Gait Speed Over the Course of Treatment and Recovery
Baseline Gait Speed
|
1.16 m/s
Standard Deviation 0.32
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Change in Gait Speed Over the Course of Treatment and Recovery
Day of surgery Gait Speed
|
1.33 m/s
Standard Deviation 0.28
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Change in Gait Speed Over the Course of Treatment and Recovery
90 Day Postop Gait Speed
|
1.36 m/s
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: Baseline, day of surgery, 90 days postoperativelyPopulation: All participants that completed the SPPB assessments were analyzed at each completed timepoint.
This standardized outcome measure asks patients to complete several activities that are scored independently and then aggregated into an overall score ranging from 0-12. Higher scores indicate better physical performance.
Outcome measures
| Measure |
Prehabilitation
n=33 Participants
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
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Change in Short Physical Performance Battery (SPPB) Over the Course of Treatment and Recovery
Baseline SPPB
|
10.44 score on a scale
Standard Deviation 1.74
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Change in Short Physical Performance Battery (SPPB) Over the Course of Treatment and Recovery
Day of surgery SPPB
|
10.83 score on a scale
Standard Deviation 1.17
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Change in Short Physical Performance Battery (SPPB) Over the Course of Treatment and Recovery
90 Day Postop SPPB
|
10.64 score on a scale
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: Baseline, day of surgery, 90 days postoperativelyPopulation: All participants that completed the RAI assessment were analyzed at each completed timepoint.
This recently published frailty index is assessed by a clinician administered questionnaire. The score and reflects frailty-associated mortality risk ranging from 0-81. Higher scores indicate higher risk for post operative complications and other frailty-related outcomes.
Outcome measures
| Measure |
Prehabilitation
n=33 Participants
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
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Change in Risk Analysis Index of Frailty (RAI) Over the Course of Treatment and Recovery
Baseline RAI
|
17.85 score on a scale
Standard Deviation 8.92
|
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Change in Risk Analysis Index of Frailty (RAI) Over the Course of Treatment and Recovery
Day of surgery RAI
|
20.40 score on a scale
Standard Deviation 8.69
|
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Change in Risk Analysis Index of Frailty (RAI) Over the Course of Treatment and Recovery
90 Day Postop RAI
|
23.30 score on a scale
Standard Deviation 9.16
|
SECONDARY outcome
Timeframe: Baseline, day of surgery, 90 days postoperativelyPopulation: All participants that completed the Subjective Global Assessment were analyzed at each completed timepoint.
This standardized survey instrument is completed by a trained clinician after assessing a nutrition-specific patient history. The minimum score is 1 and the maximum score is 7. High scores indicate better nourishment.
Outcome measures
| Measure |
Prehabilitation
n=26 Participants
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
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Change in 7-point Subjective Global Assessment (SGA) of Nutrition Over the Course of Treatment and Recovery
Baseline SGA
|
6.04 score on a scale
Standard Deviation 0.60
|
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Change in 7-point Subjective Global Assessment (SGA) of Nutrition Over the Course of Treatment and Recovery
Day of Surgery SGA
|
6.00 score on a scale
Standard Deviation 0.33
|
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Change in 7-point Subjective Global Assessment (SGA) of Nutrition Over the Course of Treatment and Recovery
90 Day Postop SGA
|
5.95 score on a scale
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: Baseline, day of surgery, 90 days postoperativelyPopulation: All participants that completed the six minute walk test were analyzed at each completed timepoint.
This standardized approach measures the distance in meters walked during 6 minutes.
Outcome measures
| Measure |
Prehabilitation
n=32 Participants
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
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Change in 6 Minute Walk Test Over the Course of Treatment and Recovery
Day of Surgery 6 Minute Walk Distance
|
400.33 meters
Standard Deviation 101.07
|
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Change in 6 Minute Walk Test Over the Course of Treatment and Recovery
Baseline 6 Minute Walk Distance
|
366.49 meters
Standard Deviation 108.68
|
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Change in 6 Minute Walk Test Over the Course of Treatment and Recovery
90 Day Postop 6 Minute Walk Distance
|
386.96 meters
Standard Deviation 94.70
|
SECONDARY outcome
Timeframe: Baseline, day of surgery, 30-days postoperatively, 90-days postoperativelyPopulation: All participants that completed all of the AQoL6D assessment were analyzed at each completed timepoint.
Assessment of Quality of Life (AQoL-6D) survey. Scores range from 0 to 1. The higher the score, the better the quality of life.
Outcome measures
| Measure |
Prehabilitation
n=25 Participants
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
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Change in Health Related Quality of Life Over the Course of Treatment and Recovery
Baseline AQoL6D Utility Score
|
0.72 score on a scale
Standard Deviation 0.16
|
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Change in Health Related Quality of Life Over the Course of Treatment and Recovery
Day of surgery AQoL6D Utility Score
|
0.75 score on a scale
Standard Deviation 0.13
|
|
Change in Health Related Quality of Life Over the Course of Treatment and Recovery
90 Day Postop AQoL6D Utility Score
|
0.77 score on a scale
Standard Deviation 0.13
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day of Surgery and 30-days postoperativelyPopulation: All participants that completed the every question of the AHRQ SCS total communication section assessment were analyzed at each completed timepoint.
Agency for Healthcare Research and Quality (AHRQ) Surgical Care Survey (SCS) total communication section. Values are scored on a 3 point scale where 1 is good and 3 bad
Outcome measures
| Measure |
Prehabilitation
n=25 Participants
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
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Change in Quality of Surgical Care Over the Course of Treatment and Recovery
Day of surgery Total Communication
|
1.08 score on a scale
Standard Deviation 0.16
|
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Change in Quality of Surgical Care Over the Course of Treatment and Recovery
30 Day Postop Total Communication
|
1.13 score on a scale
Standard Deviation 0.43
|
Adverse Events
Prehabilitation
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prehabilitation
n=35 participants at risk
Prospective sample of patients anticipating cardiothoracic surgery.
Prehabilitation: Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
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|---|---|
|
Blood and lymphatic system disorders
Orthostatic Hypotension
|
2.9%
1/35 • Number of events 1 • Adverse events were collected for each participant, from the time of enrollment, usually 3-6 weeks prior to surgery, to first final follow up, 90 days after surgery. Adverse events were collected over a time period of approximately four months.
|
|
Vascular disorders
Suspected ischemic stroke
|
2.9%
1/35 • Number of events 1 • Adverse events were collected for each participant, from the time of enrollment, usually 3-6 weeks prior to surgery, to first final follow up, 90 days after surgery. Adverse events were collected over a time period of approximately four months.
|
|
General disorders
Unrelated inpatient hospitalization
|
2.9%
1/35 • Number of events 2 • Adverse events were collected for each participant, from the time of enrollment, usually 3-6 weeks prior to surgery, to first final follow up, 90 days after surgery. Adverse events were collected over a time period of approximately four months.
|
|
General disorders
Detox
|
2.9%
1/35 • Number of events 1 • Adverse events were collected for each participant, from the time of enrollment, usually 3-6 weeks prior to surgery, to first final follow up, 90 days after surgery. Adverse events were collected over a time period of approximately four months.
|
|
Respiratory, thoracic and mediastinal disorders
Unrelated inpatient hospitalization
|
2.9%
1/35 • Number of events 2 • Adverse events were collected for each participant, from the time of enrollment, usually 3-6 weeks prior to surgery, to first final follow up, 90 days after surgery. Adverse events were collected over a time period of approximately four months.
|
|
Injury, poisoning and procedural complications
Post-operative pain unrealted inpatient hospitalization
|
2.9%
1/35 • Number of events 1 • Adverse events were collected for each participant, from the time of enrollment, usually 3-6 weeks prior to surgery, to first final follow up, 90 days after surgery. Adverse events were collected over a time period of approximately four months.
|
|
Surgical and medical procedures
Second unexpect surgery
|
2.9%
1/35 • Number of events 1 • Adverse events were collected for each participant, from the time of enrollment, usually 3-6 weeks prior to surgery, to first final follow up, 90 days after surgery. Adverse events were collected over a time period of approximately four months.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place