Low Gas Pressure vs Standard Gas Pressure in Weight-Loss Surgery

July 13, 2026 updated by: Weill Medical College of Cornell University

Comparison Between Low Pressure (8 mmHg) AirSeal Insufflation vs Standard Pressure (15 mmHg) Pneumoperitoneum on Postoperative Recovery in Bariatric Surgery: A Randomized Controlled Trial

During weight-loss surgery that is done using a robot, the surgeon needs to put carbon dioxide gas into the belly to lift the belly wall. This is done so the surgeon can adequately see all the body organs and operate safely. Many surgeons currently use a standard pressure of 15 mmHg (a unit to measure pressure). However, many patients find the use of this pressure to be painful after surgery. New research has shown that using a lower pressure with a device called "AirSeal" can safely reduce pain and lead to faster recovery after surgery.

The goal of this clinical trial is to learn if using a lower gas pressure with the AirSeal device during weight-loss surgery, compared to standard gas pressure with conventional devices, helps adults feel less pain and recover faster.

The study includes adults aged 18 or older having robotic weight-loss surgery (sleeve gastrectomy or Roux-en-Y gastric bypass) at New York-Presbyterian Hospital/Weill Cornell Medical Center.

The main questions this clinical trial aims to answer are:

  1. Does using lower gas pressure shorten the time people spend in the recovery room after surgery?
  2. Does using lower gas pressure lead to less pain and reduce the need for pain medicine after surgery?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Minimally invasive bariatric surgeries require the use of pneumoperitoneum, which is a standard of care as it creates a working environment to utilize minimally invasive tools to accomplish surgical procedures. However, there is no uniform standard pressure (usually between 12-15 mmHg). Moreover, maintaining the same pressure throughout the procedure can be inconsistent at best. Elevations in pneumoperitoneum cause significant stretch to the peritoneum which results in significant postoperative pain, longer post-anesthesia care unit (PACU) stay times, and higher opioid consumption. These effects are amplified to a higher degree in patients with severe obesity. If the pressures can be maintained and set to lower levels, then patients may have the opportunity to recover in the immediate postoperative period.

The AirSeal Robotic Solution (CONMED Corporation) is an FDA 510(k)-cleared carbon dioxide insufflation device that is indicated for use in robotic-assisted surgery.

This study is a prospective, single-center, single-blind, double-arm parallel-group randomized controlled trial that aims to determine if the use of low-pressure (8 mmHg) AirSeal insufflation, compared to standard-pressure (15 mmHg) pneumoperitoneum, provides superior patient outcomes in terms of post-operative recovery time and convalescence.

During the preoperative evaluation, participants will be consented and enrolled into the trial. Participants will then be randomly allocated to either low-pressure AirSeal insufflation (8 mmHg) or standard-pressure pneumoperitoneum (15 mmHg). Patients and outcome assessors will be blinded to allocation; however, for safety purposes, the operating surgeon and anesthesiologist cannot be blinded.

Intraoperative data (including operation time, estimated blood loss, abdominal pressure, and pressure deviations) will be recorded. Participant data related to comorbidities (i.e. body mass index, American Society of Anesthesiologists physical status, hypertension, diabetes, obstructive sleep apnea, chronic obstructive pulmonary disease/asthma, and smoking status) will be collected from the electronic medical record.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • New York-Presbyterian/Weill Cornell Medical Center GI Metabolic and Bariatric Surgery
        • Principal Investigator:
          • Cheguevara Afaneh, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18 years or older
  • Scheduled to undergo robotic-assisted Roux-en-Y gastric bypass or sleeve gastrectomy at New York-Presbyterian/Weill Cornell Medical Center
  • Obesity (body mass index≥40kg/m2 or ≥35kg/m2 with serious obesity-related health conditions)
  • American Society of Anesthesiologists physical status I-III
  • Able to understand and provide written informed consent in English

Exclusion Criteria:

  • American Society of Anesthesiologists physical status IV or higher (i.e. a severe systemic disease that is a constant threat to life such as decompensated heart failure)
  • Chronic opioid use (≥30 morphine milligram equivalents per day for ≥30 days within the past 6 months)
  • Current pregnancy
  • Inability to understand and provide informed consent in English
  • Inability to provide informed consent due to cognitive impairment or other conditions impacting decision-making capacity
  • Scheduled open or laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low-pressure pneumoperitoneum (AirSeal)

Participants who are assigned to this arm will receive 8 mmHg pneumoperitoneum using the AirSeal Robotic Solution device.

The AirSeal Robotic Solution device is a FDA 510(k)-cleared carbon dioxide insufflation platform with valveless trocar technology that helps to maintain stable intra-abdominal pressure during surgery.
Device: AirSeal Robotic Solution

The experimental intervention is low-pressure pneumoperitoneum at 8 mmHg using the AirSeal Robotic Solution device.

The AirSeal Robotic Solution (CONMED Corporation) is an FDA 510(k)-cleared carbon dioxide insufflation device that is indicated for use in robotic-assisted surgery. It consists of a console, tri-lumen filtered tube set, and access ports that function as valveless trocars.

The console of the device is mounted on a cart and regulates carbon dioxide flow and smoke evacuation by continuously measuring the intra-abdominal pressure. The trilumen filtered tube set carries carbon dioxide to the abdomen, transmits pressure information back to the console, and returns gas from the abdomen for smoke evacuation and filtration. These features allow for the device to operate in the "AirSeal" mode, whereby the pressure within the abdomen is effectively kept constant. The valveless trocars are access ports for the minimally invasive tools to enter the abdominal cavity.
Active Comparator: Standard-pressure pneumoperitoneum
Participants who are assigned to this arm will receive 15 mmHg pneumoperitoneum using the conventional insufflation machine at New York-Presbyterian/Weill Cornell Medical Center.
Other: Standard-pressure pneumoperitoneum (15 mmHg)
The control intervention is standard-pressure pneumoperitoneum set at a pressure of 15 mmHg. This will be delivered using the operating room's conventional valved-trocar carbon dioxide insufflator.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Average post-anesthesia care unit (PACU) length of stay in minutes from PACU admission to PACU discharge order
Time Frame: From PACU arrival (5 minutes post-surgery) to PACU discharge-order (1 to 4 hours post-surgery)

The PACU is the area where participants recover from anesthesia after surgery. The PACU recovery time will be computed in minutes as the interval between the documented PACU arrival timestamp and the documented PACU discharge-order timestamp which will both be abstracted from the institutional electronic medical record.

The discharge-order timestamp represents the clinical decision that the participant is fit to leave the PACU and is therefore not confounded by factors such as transport delays.
From PACU arrival (5 minutes post-surgery) to PACU discharge-order (1 to 4 hours post-surgery)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Average numeric rating scale (NRS) pain score (0-10) at PACU admission
Time Frame: PACU arrival (5 minutes post-surgery)

Postoperative pain intensity is measured using a verbally administered numeric rating scale (NRS) ranging from 0 to 10.

0 indicates no pain while 10 indicates the worst pain that the participant can imagine or has experienced. The score will be recorded as an integer.

The pain scores will be taken from the participants within 5 minutes of documented PACU arrival.
PACU arrival (5 minutes post-surgery)
Average numeric rating scale (NRS) pain score (0-10) at PACU discharge
Time Frame: PACU discharge (1-4 hours post-surgery)

Postoperative pain intensity is measured using a verbally administered numeric rating scale (NRS) ranging from 0 to 10.

0 indicates no pain while 10 indicates the worst pain that the participant can imagine or has experienced. The score will be recorded as an integer.

The pain scores will be taken from the participants within 10 minutes of PACU discharge order time stamp.
PACU discharge (1-4 hours post-surgery)
Average numeric rating scale (NRS) pain score (0-10) at post-operative day 1 (POD1)
Time Frame: Post-operative day 1 (24 hours after surgery)

Postoperative pain intensity is measured using a verbally administered numeric rating scale (NRS) ranging from 0 to 10.

0 indicates no pain while 10 indicates the worst pain that the participant can imagine or has experienced. The score will be recorded as an integer.

The pain scores will be taken from the participants on POD1 between the hours of 08:00 and 12:00. If the participant is discharged, a telephone call will be made during those hours.
Post-operative day 1 (24 hours after surgery)
Average numeric rating scale (NRS) pain score (0-10) at post-operative day 3 (POD3)
Time Frame: Post-operative day 3 (72 hours after surgery)

Postoperative pain intensity is measured using a verbally administered numeric rating scale (NRS) ranging from 0 to 10.

0 indicates no pain while 10 indicates the worst pain that the participant can imagine or has experienced. The score will be recorded as an integer.

The pain scores will be taken from the patients on POD3 between the hours of 08:00 and 12:00. If the participant is discharged, a telephone call will be made during those hours.
Post-operative day 3 (72 hours after surgery)
Average morphine milligram equivalents (MME) in the post-anesthesia care unit (PACU)
Time Frame: PACU arrival to PACU discharge (1-4 hours post-surgery)

Cumulative opioid consumption will be measured using morphine milligram equivalents (MME) which will convert all administered opioids regardless of agent or route of administration to an equivalent amount of oral morphine using standard conversion factors.

Opioid dosage data will be abstracted from the electronic medical record. The total MME administered between the PACU arrival timestamp and the documented PACU discharge-order timestamp will be recorded.

A lower cumulative MME indicates less opioid requirements.
PACU arrival to PACU discharge (1-4 hours post-surgery)
Average morphine milligram equivalents (MME) over the first 24-hour post-operative period
Time Frame: Post-operative day 1 (24 hours after surgery)

Cumulative opioid consumption will be measured using morphine milligram equivalents (MME) which will convert all administered opioids regardless of agent or route of administration to an equivalent amount of oral morphine using standard conversion factors.

Opioid dosage data will be abstracted from the electronic medical record. The total MME administered within the first 24 hours after surgery will be recorded.

A lower cumulative MME indicates less opioid requirements.
Post-operative day 1 (24 hours after surgery)
Proportion of participants experiencing postoperative nausea or vomiting in the post-anesthesia care unit (PACU)
Time Frame: PACU arrival to PACU discharge (1-4 hours post-surgery)

Postoperative nausea or vomiting is defined as any event of nausea or emesis. Episodes will be abstracted from the electronic medical record and corroborated by asking the patient.

Events will be recorded during the PACU stay
PACU arrival to PACU discharge (1-4 hours post-surgery)
Proportion of participants experiencing postoperative nausea or vomiting on post-operative day 1 (POD1)
Time Frame: Post-operative day 1 (24 hours after the surgery)

Postoperative nausea or vomiting is defined as any event of nausea or emesis. Episodes will be abstracted from the electronic medical record and corroborated by asking the patient.

Events will be recorded on POD1
Post-operative day 1 (24 hours after the surgery)
Proportion of participants experiencing postoperative nausea or vomiting on post-operative day 3 (POD3)
Time Frame: Post-operative day 3 (72 hours after the surgery)

Postoperative nausea or vomiting is defined as any event of nausea or emesis. Episodes will be abstracted from the electronic medical record and corroborated by asking the patient.

Events will be recorded on POD3
Post-operative day 3 (72 hours after the surgery)
Proportion of participants who require intra-operative conversion from robotic-assisted surgery to open surgery
Time Frame: During the surgery (about 60 to 240 minutes)
Conversion events will be abstracted from the operative note posted on the electronic medical record.
During the surgery (about 60 to 240 minutes)
Proportion of participants with clinical or radiographic subcutaneous emphysema
Time Frame: From start of surgery to PACU discharge (1-4 hours after surgery)
Cases will be identified by intraoperative inspection of the abdominal wall during the procedure, clinical examination during the PACU stay, and any postoperative imaging that is clinically obtained.
From start of surgery to PACU discharge (1-4 hours after surgery)
Proportion of participants who sustained intraoperative pressure elevation (defined as sustained increase to ≥12 mmHg for ≥10 minutes in the AirSeal arm)
Time Frame: During the surgery (about 60 to 240 minutes)
Pressure measurements will be obtained from the AirSeal console and elevations will be recorded regardless of reason.
During the surgery (about 60 to 240 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weill Medical College of Cornell University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cheguevara Afaneh, MD, New York-Presbyterian/Weill Cornell Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 26-05030301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumoperitoneum

Clinical Trials on AirSeal Robotic Solution

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings