NCT05838300

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

Lexion AP 50/30 Warmed Humidified Real Time CO2 Insufflation vs Airseal Recirculated CO2/Air Insufflation in Minimally Invasive Bariatric (Gastric Bypass) Surgery: A Randomized Controlled Study of Clinical Evaluation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-05-19
• Primary completion: 2025-09-30
• Completion: 2025-12-30
• First posted: 2023-05-01
• Last updated: 2025-06-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study