Trial Outcomes & Findings for Reducing Operative and Post-operative Morbidity in Living Kidney Donors With the Airseal System (NCT NCT02262039)
NCT ID: NCT02262039
Last Updated: 2018-01-17
Results Overview
Total Morphine Equivalents - mean in mg
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Intra-Operative on day of surgery
Results posted on
2018-01-17
Participant Flow
Participant milestones
| Measure |
Conventional Pressure
15mmHg target pressure
|
Low Pressure (VTI)
10mmHg target pressure
VTI = Valveless recirculating insufflation
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
27
|
|
Overall Study
COMPLETED
|
14
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Operative and Post-operative Morbidity in Living Kidney Donors With the Airseal System
Baseline characteristics by cohort
| Measure |
Conventional Pressure
n=14 Participants
15mmHg target pressure
|
Low Pressure (VTI)
n=27 Participants
10mmHg target pressure
VTI= Valveless recirculating insufflation
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.6 years
STANDARD_DEVIATION 12.3 • n=39 Participants
|
51.6 years
STANDARD_DEVIATION 14.5 • n=41 Participants
|
47.6 years
STANDARD_DEVIATION 13.2 • n=35 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White
|
11 participants
n=39 Participants
|
22 participants
n=41 Participants
|
33 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 participants
n=39 Participants
|
2 participants
n=41 Participants
|
4 participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=39 Participants
|
3 participants
n=41 Participants
|
4 participants
n=35 Participants
|
|
Nephrectomy Laterality
Left
|
11 participants
n=39 Participants
|
24 participants
n=41 Participants
|
35 participants
n=35 Participants
|
|
Nephrectomy Laterality
Right
|
3 participants
n=39 Participants
|
3 participants
n=41 Participants
|
6 participants
n=35 Participants
|
|
ASA Class
1
|
9 participants
n=39 Participants
|
17 participants
n=41 Participants
|
26 participants
n=35 Participants
|
|
ASA Class
2
|
5 participants
n=39 Participants
|
10 participants
n=41 Participants
|
15 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Intra-Operative on day of surgeryTotal Morphine Equivalents - mean in mg
Outcome measures
| Measure |
Conventional Pressure
n=14 Participants
15mmHg target pressure
|
Low Pressure (VTI)
n=27 Participants
10mmHg target pressure
VTI= Valveless recirculating insufflation
|
|---|---|---|
|
Narcotic Use (mg)
|
113.8 mg
Standard Deviation 19
|
99.6 mg
Standard Deviation 25
|
PRIMARY outcome
Timeframe: Post-operative (until time of discharge, typically 2-4 days)Total Morphine Equivalents - mean in mg
Outcome measures
| Measure |
Conventional Pressure
n=14 Participants
15mmHg target pressure
|
Low Pressure (VTI)
n=27 Participants
10mmHg target pressure
VTI= Valveless recirculating insufflation
|
|---|---|---|
|
Narcotic Use (mg)
|
130.8 mg
Standard Deviation 125.6
|
134.5 mg
Standard Deviation 80.2
|
PRIMARY outcome
Timeframe: Operative and Post-operative (until time of discharge, typically 2-4 days)Total Morphine Equivalent - mean in mg
Outcome measures
| Measure |
Conventional Pressure
n=14 Participants
15mmHg target pressure
|
Low Pressure (VTI)
n=27 Participants
10mmHg target pressure
VTI= Valveless recirculating insufflation
|
|---|---|---|
|
Narcotic Use (mg)
|
244.6 mg
Standard Deviation 126.7
|
234.0 mg
Standard Deviation 88.0
|
SECONDARY outcome
Timeframe: 1 hour post-opPain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.
Outcome measures
| Measure |
Conventional Pressure
n=14 Participants
15mmHg target pressure
|
Low Pressure (VTI)
n=27 Participants
10mmHg target pressure
VTI= Valveless recirculating insufflation
|
|---|---|---|
|
Subjective Pain Score
|
4.6 units on a scale
Standard Deviation 3.2
|
5.3 units on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 6 hours post-opPain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0)- A score of 0 indicates no pain.
Outcome measures
| Measure |
Conventional Pressure
n=14 Participants
15mmHg target pressure
|
Low Pressure (VTI)
n=27 Participants
10mmHg target pressure
VTI= Valveless recirculating insufflation
|
|---|---|---|
|
Subjective Pain Score
|
3.5 units on a scale
Standard Deviation 3.2
|
4.6 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 12 hours post-opPain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.
Outcome measures
| Measure |
Conventional Pressure
n=14 Participants
15mmHg target pressure
|
Low Pressure (VTI)
n=27 Participants
10mmHg target pressure
VTI= Valveless recirculating insufflation
|
|---|---|---|
|
Subjective Pain Score
|
3.9 units on a scale
Standard Deviation 3.0
|
3.7 units on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: intraoperativemean End-tidal carbon dioxide concentration in the expired air
Outcome measures
| Measure |
Conventional Pressure
n=14 Participants
15mmHg target pressure
|
Low Pressure (VTI)
n=27 Participants
10mmHg target pressure
VTI= Valveless recirculating insufflation
|
|---|---|---|
|
Mean ETCO2
|
29.7 mmHg
Standard Deviation 4.4
|
30.8 mmHg
Standard Deviation 3.0
|
Adverse Events
Conventional Pressure
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Low Pressure (VTI)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Conventional Pressure
n=14 participants at risk
15mmHg target pressure
|
Low Pressure (VTI)
n=27 participants at risk
10mmHg target pressure
VTI= Valveless recirculating insufflation
|
|---|---|---|
|
Surgical and medical procedures
Post-operative hemorrhage
|
7.1%
1/14 • Number of events 1 • 1 month
Systematic chart reviews were conducted
|
0.00%
0/27 • 1 month
Systematic chart reviews were conducted
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
7.1%
1/14 • Number of events 1 • 1 month
Systematic chart reviews were conducted
|
0.00%
0/27 • 1 month
Systematic chart reviews were conducted
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Number of events 1 • 1 month
Systematic chart reviews were conducted
|
0.00%
0/27 • 1 month
Systematic chart reviews were conducted
|
|
Infections and infestations
Wound infection
|
0.00%
0/14 • 1 month
Systematic chart reviews were conducted
|
7.4%
2/27 • Number of events 2 • 1 month
Systematic chart reviews were conducted
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60