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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Bariatric Surgery

Intervention / Treatment
-----------------
* Device: Warm humidified CO2
* Device: Dry CO2


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carbon dioxide, minimally invasive surgery