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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: Conventional pressure; Device: Valveless recirculating insufflation (VTI)

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Transplantation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Pressure; Conventional Insufflation with 15mmHg target pressure	Device: Conventional pressure; 15 mmHg target pressure
Experimental: Low Pressure (VTI); Valveless recirculating insufflation (VTI) with 10mmHg target pressure	Device: Valveless recirculating insufflation (VTI); 10 mmHg target pressure

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: SurgiQuest, Inc.
• Investigators: Study Director: Sanjay Kulkarni, MD, Yale University

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: July 9, 2014
• First Submitted That Met QC Criteria: October 6, 2014
• First Posted (Estimate): October 10, 2014

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 12, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: kidney; living; donors
• Other Study ID Numbers: 1405013985

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No