Lexion AP 50/30 Warmed Humidified Real Time CO2 Insufflation vs Airseal Recirculated CO2/Air Insufflation in Minimally Invasive Bariatric (Gastric Bypass) Surgery

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT05838300
Status
Recruiting
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Conditions

  • Bariatric Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Warm humidified CO2 — DEVICE
    Participants will receive warm (37°C) and humidified (95%) CO2.The humidification and warming device to be used is AlwaysPneumo® AP 50/30 InsuflowPort® (Lexion Medical, FDA approved) which is a specialized port that delivers warmed (95° F) and humidified (95% relative humidity) CO2, the source of which is a standard CO2 tank or wall source
  • Dry CO2 — DEVICE
    Participants will receive standard cold (19-21 °C) and non-humidified (0%) CO2 insufflation with Airseal Insufflator

Study Details

The purpose of this study is to To determine the effect of warm and humidified (WH) carbon dioxide (CO2) on post-operative pain/analgesia requirement in patients undergoing laparoscopic bariatric surgery.

Key Dates

Start date
May 19, 2023
Status verified
Jun 2025
Primary completion
Sep 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Warm humidified CO2
  • Active Comparator: Dry CO2

Primary Outcome Measure

Pain as assessed by the visual analog scale (VAS) [ Time Frame: First 24 hours after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Erik B Wilson, MD, FACS
[email protected]
713-500-7277
Angielyn Rivera
[email protected]
713-416-1350

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By research site
The University of Texas Health Science Center at Houston· Houston, TX

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