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Robotic SurgeryNCT07710352

Low Gas Pressure vs Standard Gas Pressure in Robotic Surgery

A study testing AirSeal Robotic Solution and Standard-pressure pneumoperitoneum (15 mmHg) in people with Robotic Surgery and Pneumoperitoneum, run by Weill Medical College of Cornell University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

During 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Robotic Surgery, Pneumoperitoneum
What is being tested?
AirSeal Robotic Solution and Standard-pressure pneumoperitoneum (15 mmHg)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
30 Jul 2026to Feb 2027
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 years or older
  • Scheduled to undergo robotic-assisted surgery at New York-Presbyterian/Weill Cornell Medical Center
  • American Society of Anesthesiologists physical status I-III
  • Able to understand and provide written informed consent in English

Who cannot join

  • 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 surgeries

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cheguevara Afaneh, MD contact

(646) 962-8462

cha9043@med.cornell.edu

United States1 site, 1 recruiting
  • New York-Presbyterian/Weill Cornell Medical Center GI Metabolic and Bariatric Surgery

    New York, New York, 10021

    Cheguevara Afaneh, MD, (646) 962-8462, cha9043@med.cornell.edu

    Cheguevara Afaneh, MD

    Recruiting

Other trials in United States

About this study

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

During 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 robotic surgery, compared to standard gas pressure with conventional devices, helps adults feel less pain and recover faster.

Read more

The study includes adults aged 18 or older having robotic 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?
Read the detailed description

Robotic 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.

Being tested
AirSeal Robotic Solution, Standard-pressure pneumoperitoneum (15 mmHg)
Keywords
robotic surgery, low-pressure pneumoperitoneum, recovery time, pain, pneumoperitoneum
Medical subject headings
Pneumoperitoneum, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AirSeal Robotic SolutionDevice

    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.

  • Standard-pressure pneumoperitoneum (15 mmHg)Other

    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.

Study groups in NCT07710352
Study groupRoleWhat they receive
Low-pressure pneumoperitoneum (AirSeal)ExperimentalParticipants 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.
Receives: Device: AirSeal Robotic Solution
Standard-pressure pneumoperitoneumActive comparatorParticipants who are assigned to this arm will receive 15 mmHg pneumoperitoneum using the conventional insufflation machine at New York-Presbyterian/Weill Cornell Medical Center.
Receives: Other: Standard-pressure pneumoperitoneum (15 mmHg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average post-anesthesia care unit (PACU) length of stay in minutes from PACU admission to PACU discharge order

    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.

    Measured: From PACU arrival (5 minutes post-surgery) to PACU discharge-order (1 to 4 hours post-surgery)

Secondary outcomes (12)
  1. Average numeric rating scale (NRS) pain score (0-10) at PACU admission

    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.

    Measured: PACU arrival (5 minutes post-surgery)

  2. Average numeric rating scale (NRS) pain score (0-10) at PACU discharge

    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.

    Measured: PACU discharge (1-4 hours post-surgery)

  3. Average numeric rating scale (NRS) pain score (0-10) at post-operative day 1 (POD1)

    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.

    Measured: Post-operative day 1 (24 hours after surgery)

  4. Average numeric rating scale (NRS) pain score (0-10) at post-operative day 3 (POD3)

    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.

    Measured: Post-operative day 3 (72 hours after surgery)

  5. Average morphine milligram equivalents (MME) in the post-anesthesia care unit (PACU)

    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.

    Measured: PACU arrival to PACU discharge (1-4 hours post-surgery)

  6. Average morphine milligram equivalents (MME) over the first 24-hour post-operative period

    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.

    Measured: Post-operative day 1 (24 hours after surgery)

  7. Proportion of participants experiencing postoperative nausea or vomiting in the post-anesthesia care unit (PACU)

    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

    Measured: PACU arrival to PACU discharge (1-4 hours post-surgery)

  8. Proportion of participants experiencing postoperative nausea or vomiting on post-operative day 1 (POD1)

    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

    Measured: Post-operative day 1 (24 hours after the surgery)

  9. Proportion of participants experiencing postoperative nausea or vomiting on post-operative day 3 (POD3)

    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

    Measured: Post-operative day 3 (72 hours after the surgery)

  10. Proportion of participants who require intra-operative conversion from robotic-assisted surgery to open surgery

    Conversion events will be abstracted from the operative note posted on the electronic medical record.

    Measured: During the surgery (about 60 to 240 minutes)

  11. Proportion of participants with clinical or radiographic subcutaneous emphysema

    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.

    Measured: From start of surgery to PACU discharge (1-4 hours after surgery)

  12. Proportion of participants who sustained intraoperative pressure elevation (defined as sustained increase to ≥12 mmHg for ≥10 minutes in the AirSeal arm)

    Pressure measurements will be obtained from the AirSeal console and elevations will be recorded regardless of reason.

    Measured: During the surgery (about 60 to 240 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2026
  2. Study start30 Jul 2026
  3. Primary completionJan 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomization will be performed using a computer-generated permuted block sequence pre-loaded into REDCap with allocation concealed until the day of surgery. Allocation will be blinded to participants and outcome assessors. Surgical staff cannot be blinded to allocation for safety reasons.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07710352
Sponsor's protocol ID
26-05030301
Status last verified
Aug 2026
First submitted
13 Jul 2026
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing AirSeal Robotic Solution and Standard-pressure pneumoperitoneum (15 mmHg) in people with Robotic Surgery and Pneumoperitoneum, run by Weill Medical College of Cornell University 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 4 inclusion and 6 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 20 Aug 2026. 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 Cheguevara Afaneh, MD ((646) 962-8462, cha9043@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). 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 20 Aug 2026.

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