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CompletedNCT02262039Updated Jan 17, 2018Results posted

Reducing Operative and Post-operative Morbidity in Living Kidney Donors With the Airseal System

An interventional study of Valveless recirculating insufflation (VTI) and Conventional pressure in Pain, sponsored by Yale University. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2018-01-17.

Sponsored by Yale University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Randomized
Sex
All
01

Study summary

The purpose of this study is to determine if the Airseal System will reduce post-operative pain and reduce the need for narcotics in laparoscopic living kidney donor surgeries.

Read the detailed description

Our hypothesis is that Airseal Insufflation System will provide reduced mean operative insufflation pressure and operative mean ETCO2, resulting in improved post-operative pain control and improved operative safety.

The Airseal System has demonstrated decreased variability in intra-abdominal pressure, less post-operative shoulder pain, lower mean ETCO2 and reduced narcotic pain administration. These metrics have been demonstrated in human subjects undergoing gynecologic, urologic and bariatric procedures. The established benefits in a human model provide a foundation for translating this technology to living kidney donors. The advantage lies in the ability to improve pain-related outcomes in this population, which translates into increased living donation; the single solution to reduce mortality for patients suffering from end-stage kidney disease.

02

Conditions studied

  • Pain

Keywords

  • living
  • kidney
  • donors
03

In context

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Any living donor who has been approved to donate a kidney is eligible to participate.

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
41 participants (actual)

Study arms

  • Active comparator
    Conventional Pressure

    Conventional Insufflation with 15mmHg target pressure

    Device: Conventional pressure

  • Experimental
    Low Pressure (VTI)

    Valveless recirculating insufflation (VTI) with 10mmHg target pressure

    Device: Valveless recirculating insufflation (VTI)

Interventions

  • DeviceValveless recirculating insufflation (VTI)

    10 mmHg target pressure

  • DeviceConventional pressure

    15 mmHg target pressure

06

What researchers measure

Primary outcomes

  1. Narcotic Use (mg)

    Total Morphine Equivalents - mean in mg

    Time frame: Intra-Operative on day of surgery

  2. Narcotic Use (mg)

    Total Morphine Equivalents - mean in mg

    Time frame: Post-operative (until time of discharge, typically 2-4 days)

  3. Narcotic Use (mg)

    Total Morphine Equivalent - mean in mg

    Time frame: Operative and Post-operative (until time of discharge, typically 2-4 days)

Secondary outcomes

  1. Subjective Pain Score

    Pain 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.

    Time frame: 1 hour post-op

  2. Subjective Pain Score

    Pain 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.

    Time frame: 6 hours post-op

  3. Subjective Pain Score

    Pain 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.

    Time frame: 12 hours post-op

  4. Mean ETCO2

    mean End-tidal carbon dioxide concentration in the expired air

    Time frame: intraoperative

07

Results

Posted Dec 23, 2016

Participant flow

Participant flow — Overall Study
MilestoneConventional PressureLow Pressure (VTI)
Started1427
Completed1427
Not completed00

Outcome measures

PrimaryNarcotic Use (mg)

Total Morphine Equivalents - mean in mg

Time frame:
Intra-Operative on day of surgery
Reported as:
Mean · mg
Narcotic Use (mg)
mgConventional PressureLow Pressure (VTI)
Narcotic Use (mg)113.8 ± 1999.6 ± 25
Statistical analysis
  • Conventional Pressure vs Low Pressure (VTI) · t-test, 2 sided · p = <0.05
PrimaryNarcotic Use (mg)

Total Morphine Equivalents - mean in mg

Time frame:
Post-operative (until time of discharge, typically 2-4 days)
Reported as:
Mean · mg
Narcotic Use (mg)
mgConventional PressureLow Pressure (VTI)
Narcotic Use (mg)130.8 ± 125.6134.5 ± 80.2
Statistical analysis
  • Conventional Pressure vs Low Pressure (VTI) · t-test, 2 sided · p = 0.92
PrimaryNarcotic Use (mg)

Total Morphine Equivalent - mean in mg

Time frame:
Operative and Post-operative (until time of discharge, typically 2-4 days)
Reported as:
Mean · mg
Narcotic Use (mg)
mgConventional PressureLow Pressure (VTI)
Narcotic Use (mg)244.6 ± 126.7234.0 ± 88.0
Statistical analysis
  • Conventional Pressure vs Low Pressure (VTI) · t-test, 2 sided · p = 0.78
SecondarySubjective Pain Score

Pain 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.

Time frame:
1 hour post-op
Reported as:
Mean · units on a scale
Subjective Pain Score
units on a scaleConventional PressureLow Pressure (VTI)
Subjective Pain Score4.6 ± 3.25.3 ± 3.2
Statistical analysis
  • Conventional Pressure vs Low Pressure (VTI) · t-test, 2 sided · p = 0.52
SecondarySubjective Pain Score

Pain 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.

Time frame:
6 hours post-op
Reported as:
Mean · units on a scale
Subjective Pain Score
units on a scaleConventional PressureLow Pressure (VTI)
Subjective Pain Score3.5 ± 3.24.6 ± 2.6
Statistical analysis
  • Conventional Pressure vs Low Pressure (VTI) · t-test, 2 sided · p = 0.25
SecondarySubjective Pain Score

Pain 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.

Time frame:
12 hours post-op
Reported as:
Mean · units on a scale
Subjective Pain Score
units on a scaleConventional PressureLow Pressure (VTI)
Subjective Pain Score3.9 ± 3.03.7 ± 2.7
Statistical analysis
  • Conventional Pressure vs Low Pressure (VTI) · t-test, 2 sided · p = 0.82
SecondaryMean ETCO2

mean End-tidal carbon dioxide concentration in the expired air

Time frame:
intraoperative
Reported as:
Mean · mmHg
Mean ETCO2
mmHgConventional PressureLow Pressure (VTI)
Mean ETCO229.7 ± 4.430.8 ± 3.0
Statistical analysis
  • Conventional Pressure vs Low Pressure (VTI) · t-test, 2 sided · p = 0.45

Adverse events

Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Conventional Pressure—0/14 (0%)3/14 (21.4%)
Low Pressure (VTI)—0/27 (0%)2/27 (7.4%)
Most frequent other events
Most frequent other events
EventConventional PressureLow Pressure (VTI)
Wound infectionInfections and infestations0/142/27
Post-operative hemorrhageSurgical and medical procedures1/140/27
Aspiration pneumoniaRespiratory, thoracic and mediastinal disorders1/140/27
Urinary tract infectionInfections and infestations1/140/27

Baseline characteristics

All participants who agreed to participate completed the study and are included in the analysis.

Age, Continuous
Age, Continuous(years)Conventional PressureLow Pressure (VTI)Total
Mean45.6 ± 12.351.6 ± 14.547.6 ± 13.2
Sex: Female, Male
Sex: Female, Male(Participants)Conventional PressureLow Pressure (VTI)Total
Female81624
Male61117
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Conventional PressureLow Pressure (VTI)Total
White112233
African American224
Hispanic134
Nephrectomy Laterality
Nephrectomy Laterality(participants)Conventional PressureLow Pressure (VTI)Total
Left112435
Right336
ASA Class
ASA Class(participants)Conventional PressureLow Pressure (VTI)Total
191726
251015
08

Study locations

1 site
  • Yale New Haven Transplantation Center
    New Haven, Connecticut 06520, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02262039
Lead sponsor
Yale University
Collaborators
SurgiQuest, Inc.
Responsible party
Sponsor
First posted
Oct 10, 2014
Start date
Aug 2014
Primary completion
Dec 2015
Completion
Feb 2016
Results posted
Dec 23, 2016
Last update
Jan 17, 2018

Study contacts

Sanjay Kulkarni, MD
study director · Yale University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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