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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Reducing Operative and Post-operative Morbidity in Living Kidney Donors With the Airseal System: A Randomized Control Trial

Conditions
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Pain

Intervention / Treatment
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* Device: Valveless recirculating insufflation (VTI)
* Device: Conventional pressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any living donor who has been approved to donate a kidney is eligible to participate. Exclusion Criteria: none
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Pressure<br>Conventional Insufflation with 15mmHg target pressure | Device: Conventional pressure<br>* 15 mmHg target pressure<br>|
| Experimental: Low Pressure (VTI)<br>Valveless recirculating insufflation (VTI) with 10mmHg target pressure | Device: Valveless recirculating insufflation (VTI)<br>* 10 mmHg target pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotic Use (mg) | Total Morphine Equivalents - mean in mg | Intra-Operative on day of surgery | 
| Narcotic Use (mg) | Total Morphine Equivalents - mean in mg | Post-operative (until time of discharge, typically 2-4 days) | 
| Narcotic Use (mg) | Total Morphine Equivalent - mean in mg | Operative and Post-operative (until time of discharge, typically 2-4 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 hour post-op | 
| 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. | 6 hours post-op | 
| 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. | 12 hours post-op | 
| Mean ETCO2 | mean End-tidal carbon dioxide concentration in the expired air | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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living, kidney, donors