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

NCT05838300 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-06-13

No results posted yet for this study

Summary

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.

Conditions

  • Bariatric Surgery

Interventions

DEVICE

Warm humidified CO2

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

DEVICE

Dry CO2

Participants will receive standard cold (19-21 °C) and non-humidified (0%) CO2 insufflation with Airseal Insufflator

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Erik Wilson, MD, FACS · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-19
Primary Completion
2025-09-30
Completion
2025-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05838300 on ClinicalTrials.gov