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

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.

Study Overview

• Status: Recruiting
• Conditions: Bariatric Surgery
• Intervention / Treatment: Device: Warm humidified CO2; Device: Dry CO2

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angielyn Rivera; Phone Number: 713-416-1350; Email: Angielyn.R.Rivera@uth.tmc.edu
• Study Contact Backup: Name: Erik B Wilson, MD,FACS; Phone Number: 713-500-7277; Email: Erik.B.Wilson@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Angielyn Rivera; Phone Number: 713-416-1350; Email: Angielyn.R.Rivera@uth.tmc.edu
      • Contact: Erik B Wilson, MD, FACS; Phone Number: 713-500-7277; Email: Erik.B.Wilson@uth.tmc.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• elective bariatric primary or revision procedures and hiatal hernia repair procedures for all indications.

Exclusion Criteria:

• emergency surgery, reoperation within 30 days
• patients who are taking pain medications (narcotics) daily preoperatively for whatever reason
• history of narcotics addiction
• paraplegic and quadriplegic patients
• dementia or altered mental status
• patients on steroids
• pregnant women
• psychiatric patients
• minors
• unable to give informed consent

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Warm humidified CO2	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
Active Comparator: Dry CO2	Device: Dry CO2; Participants will receive standard cold (19-21 °C) and non-humidified (0%) CO2 insufflation with Airseal Insufflator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain as assessed by the visual analog scale (VAS)	This will be measured as a binary outcome variable (pain will be determined as VAS >/= 4, and no pain will be VAS < 4). This will be determined on post-operative day 1 as an average of the two pain scores.	First 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative temperature measured via bladder probe (average of the measurements on the anesthesia record)	the body temperature of the patient from the bladder	From the start surgery to the end of the surgery in minutes
Temperature in the PACU	the temperature of the patient in PACU measured each 30 minutes in PACU	From the time the patient enters PACU to the time patient leaves the PACU in minutes
Analgesic requirements in the Post Anesthesia Care Unit (PACU)	the amount, type and doses of drugs administered in the PACU to the patient	From the time the patient enters the PACU to the time patient leaves the PACU in minutes
Volume of CO2 consumed during the procedure	the amount/volume of CO2 used during the procedure	from the time the CO2 machine is turned on to the time the CO2 machine is turned off in minutes
Length of hospital stay	from admission to the hospital to discharge from the hospital in hours	the amount of hours the patient stays in the hospital (ie 24 hours)
Duration of surgery	from the start of the first incision of surgery to the closing of the last incision of surgery in minutes	From start of the surgery to the end of the surgery in minutes
Incision length	the length of the incisions on the patient abdomen	measurement in centimeters the patients incision lengths at the closing of the surgery
Intra-operative and total hospital costs	the cost for the intra-operative services and total hospital hospital costs	from the admission to discharge of the patient in hours
Total narcotic use intra-operatively (in morphine milliequivalents)	volume of narcotics used during the operation	volume of narcotics used from the beginning of surgery to end of surgery in milliequivalents
Postoperative Analgesia Requirement measured in morphine milliequivalents	the amount of analgesia used type, dose and amounts used post operatively	any postoperative analgesia used after the surgery is completed to the discharge of the patient from the hospital

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Erik Wilson, MD, FACS, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: minimally invasive surgery; carbon dioxide
• Other Study ID Numbers: HSC-MS-22-0444

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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