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

NCT ID: NCT05838300

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-19

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bariatric Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Warm humidified CO2

Group Type EXPERIMENTAL

Warm humidified CO2

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

Dry CO2

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Dry CO2

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Erik B Wilson

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erik Wilson, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Erik B Wilson, MD,FACS

Role: CONTACT

713-500-7277

Angielyn Rivera

Role: CONTACT

713-416-1350

Facility Contacts

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Erik B Wilson, MD, FACS

Role: primary

713-500-7277

Angielyn Rivera

Role: backup

713-416-1350

Other Identifiers

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HSC-MS-22-0444

Identifier Type: -

Identifier Source: org_study_id

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