Bariatric SurgeryNCT05838300
Lexion AP 50/30 Warmed Humidified Real Time CO2 Insufflation vs Airseal Recirculated CO2/Air Insufflation in Minimally Invasive Bariatric (Gastric Bypass) Surgery
A study testing Warm humidified CO2 and Dry CO2 in people with Bariatric Surgery, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- Warm humidified CO2 and Dry CO2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective bariatric primary or revision procedures and hiatal hernia repair procedures for all indications.
Who cannot join
- 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
Show all 10Show fewer
- pregnant women
- psychiatric patients
- minors
- unable to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Erik B Wilson, MD, FACS, 713-500-7277, Erik.B.Wilson@uth.tmc.edu
Angielyn Rivera, 713-416-1350, Angielyn.R.Rivera@uth.tmc.edu
About this study
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
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.
- Conditions
- Bariatric Surgery
- Being tested
- Warm humidified CO2, Dry CO2
- Keywords
- carbon dioxide, minimally invasive surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Dry CO2Device
Participants will receive standard cold (19-21 °C) and non-humidified (0%) CO2 insufflation with Airseal Insufflator
| Study group | Role | What they receive |
|---|---|---|
| Warm humidified CO2 | Experimental | Not described Receives: Device: Warm humidified CO2 |
| Dry CO2 | Active comparator | Not described Receives: Device: Dry CO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 24 hours after surgery
Secondary outcomes (10)
Intraoperative temperature measured via bladder probe (average of the measurements on the anesthesia record)
the body temperature of the patient from the bladder
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From start of the surgery to the end of the surgery in minutes
Incision length
the length of the incisions on the patient abdomen
Measured: 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
Measured: 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
Measured: 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
Measured: any postoperative analgesia used after the surgery is completed to the discharge of the patient from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start19 May 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik B Wilson, The University of Texas Health Science Center, Houston
- Investigators
- Erik Wilson, MD, FACS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838300
- Sponsor's protocol ID
- HSC-MS-22-0444
- Status last verified
- Jun 2025
- First submitted
- 4 Apr 2023
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05838300
- Acronym / sponsor ID
- HSC-MS-22-0444
- Conditions
- Bariatric Surgery
- Keywords
- carbon dioxide, minimally invasive surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 19 May 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warm humidified CO2 | Experimental | Device: Warm humidified CO2 |
| Dry CO2 | Active comparator | Device: Dry CO2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective bariatric primary or revision procedures and hiatal hernia repair procedures for all indications.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warm humidified CO2Participants 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 | Warm humidified CO2 |
| Dry CO2Participants will receive standard cold (19-21 °C) and non-humidified (0%) CO2 insufflation with Airseal Insufflator | Device | Dry CO2 |
Primary outcome
Pain as assessed by the visual analog scale (VAS)
Time frame: First 24 hours after surgery
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erik Wilson, MD, FACS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm humidified CO2 and Dry CO2 in people with Bariatric Surgery, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erik B Wilson, MD,FACS (713-500-7277, Erik.B.Wilson@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain as assessed by the visual analog scale (VAS) (time frame: First 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.