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Recruiting NCT05838300

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

No phase Interventional Bariatric Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Warm humidified CO2, Dry CO2.
Who it may be relevant to
Registry conditions: Bariatric Surgery. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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

Primary outcome measures

  • Pain as assessed by the visual analog scale (VAS) [Time frame: First 24 hours after surgery]
Secondary outcome measures (10)
  • Intraoperative temperature measured via bladder probe (average of the measurements on the anesthesia record) [Time frame: From the start surgery to the end of the surgery in minutes]
  • Temperature in the PACU [Time frame: 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) [Time frame: From the time the patient enters the PACU to the time patient leaves the PACU in minutes]
  • Volume of CO2 consumed during the procedure [Time frame: from the time the CO2 machine is turned on to the time the CO2 machine is turned off in minutes]
  • Length of hospital stay [Time frame: the amount of hours the patient stays in the hospital (ie 24 hours)]
  • Duration of surgery [Time frame: From start of the surgery to the end of the surgery in minutes]
  • Incision length [Time frame: measurement in centimeters the patients incision lengths at the closing of the surgery]
  • Intra-operative and total hospital costs [Time frame: from the admission to discharge of the patient in hours]
  • Total narcotic use intra-operatively (in morphine milliequivalents) [Time frame: volume of narcotics used from the beginning of surgery to end of surgery in milliequivalents]
  • Postoperative Analgesia Requirement measured in morphine milliequivalents [Time frame: any postoperative analgesia used after the surgery is completed to the discharge of the patient from the hospital]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT05838300 · HSC-MS-22-0444

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗