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

Bariatric Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05838300
• Other study ID #: HSC-MS-22-0444
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Erik B Wilson, MD,FACS
• Phone: 713-500-7277
• Email: Erik.B.Wilson[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	Incision length	the length of the incisions on the patient abdomen	measurement in centimeters the patients incision lengths at the closing of the surgery
Secondary	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
Secondary	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
Secondary	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