NCT05838300

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

May 19, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

2.4 years

First QC Date

April 4, 2023

Last Update Submit

June 10, 2025

Conditions

Bariatric Surgery

Keywords

carbon dioxideminimally invasive surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Intraoperative temperature measured via bladder probe (average of the measurements on the anesthesia record)

    From the start surgery to the end of the surgery in minutes

  • Temperature in the 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)

    From the time the patient enters the PACU to the time patient leaves the PACU in minutes

  • Volume of CO2 consumed 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

    the amount of hours the patient stays in the hospital (ie 24 hours)

  • +5 more secondary outcomes

Study Arms (2)

Warm humidified CO2

EXPERIMENTAL
Device: Warm humidified CO2

Dry CO2

ACTIVE COMPARATOR
Device: Dry CO2

Interventions

Warm humidified CO2DEVICE

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

Warm humidified CO2
Dry CO2DEVICE

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

Dry CO2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Study Officials

  • Erik Wilson, MD, FACS

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erik B Wilson, MD,FACS

CONTACT

713-500-7277Erik.B.Wilson@uth.tmc.edu

Angielyn Rivera

CONTACT

713-416-1350Angielyn.R.Rivera@uth.tmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 4, 2023

First Posted

May 1, 2023

Study Start

May 19, 2023

Primary Completion

September 30, 2025

Study Completion

December 30, 2025

Last Updated

June 13, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)