ObeseNCT07774065
Mechanical Ventilation in Obese Surgical Patients
A study testing Standard PEEP (8 cmH₂O) in people with Obese, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether an intraoperative positive end-expiratory pressures (PEEP) setting strategy aimed at minimizing the mechanical power delivered to the lungs via transpulmonary pressure improves postoperative outcomes in obese patients undergoing conventional laparoscopic or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obese
- What is being tested?
- Standard PEEP (8 cmH₂O)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2026to 31 Jul 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
- Age ≥ 18 years;
- Body Mass Index (BMI) ≥ 35 kg/m2;
- Scheduled for laparoscopic surgery expected to exceed 2h (from incision to closure) under general anesthesia, as determined pre-operatively by the attending surgeon and surgical team based on typical scheduling estimates, prior experience, procedure type, planned surgical approach, and patient-specific factors.
Who cannot join
- Previous lung surgery;
- Invasive mechanical ventilation for >30 minutes within the last 30 days prior to surgery;
- Receipt of immunosuppressive medication (chemotherapy or radiotherapy) up to two months prior to surgery;
- Neurological procedures or cardiac surgery;
- Need for one-lung ventilation or planned re-intubation following surgery;
- Requirement for intraoperative prone or lateral decubitus positioning;
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- Enrollment in another interventional study or refusal to give written informed consent;
- Pregnancy, determined by anamnesis and/or laboratory testing;
- Persistent hemodynamic instability or intractable shock, considered hemodynamically unsuitable for the study by the patient's managing physician;
- Severe chronic obstructive pulmonary disease (COPD, defined as non-invasive ventilation and/or oxygen therapy at home or repeated systemic corticosteroid therapy for acute exacerbations of COPD);
- Severe cardiac disease (defined as New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmia);
- Acute respiratory distress syndrome (according to the Berlin definition 2) expected to require prolonged postoperative mechanical ventilation;
- Severe pulmonary arterial hypertension (defined as systolic pulmonary artery pressure > 40 mmHg)
- Intracranial injury, intracranial tumor, or neuromuscular disease;
- Known esophageal disease or anatomy that would preclude the safe placement of a standard orogastric tube
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
University of Texas Medical Branch, Galveston
Galveston, Texas, 77555
Negar Motayagheni, nemotaya@utmb.edu
About this study
Official title: Minimizing Post-Operative Pulmonary Complications in Patients With a BMI =35 kg/m2 Undergoing Robotic-Assisted or Conventional Laparoscopic Surgery
The purpose of this study is to evaluate whether an intraoperative positive end-expiratory pressures (PEEP) setting strategy aimed at minimizing the mechanical power delivered to the lungs via transpulmonary pressure improves postoperative outcomes in obese patients undergoing conventional laparoscopic or robotic-assisted surgery. The objectives are to determine whether this strategy reduces immediate postoperative hypoxemia, and to assess whether it mitigates lung injury as reflected by relevant blood biomarkers.
- Conditions
- Obese
- Being tested
- Standard PEEP (8 cmH₂O)
- Keywords
- Robotic Surgery, Body Mass Index (BMI) ≥ 35 kg/m2, Laparoscopic Surgery, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard PEEP (8 cmH₂O)Procedure or surgery
Participants will receive standard intraoperative mechanical ventilation with a fixed positive end-expiratory pressure (PEEP) of 8 cmH₂O maintained throughout the surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Transpulmonary Pressure-Guided Individualized PEEP | Experimental | A transpulmonary-guided individualized positive end-expiratory pressure (PEEPPTP) will be set as follows: (A) The intervention is initiated by a recruitment maneuver consisting of 5 cmH2O-stepwise (30 sec) PEEP increases until either maximum PEEP=30 cmH2O or end-inspiratory PTP>25 cmH2O is reached. Settings: volume-controlled ventilation, VT=7ml/kg, I:E=1:1, inspiratory pause=20%, RR=10bpm, FiO2=80%. (B) Following recruitment, PEEP will be set to the value used immediately before the recruitment maneuver and PEso-EE assessed.
PEEPPTP=PEso-EE+1-2 cmH2O. (C) PEEP will then be set for 30 sec at the highest value achieved during recruitment, followed by (D) PEEPPTP. Individualized PEEP-setting will be performed after: (1) induction of anesthesia, (2) pneumoperitoneum and final surgical position, including Trendelenburg and robot docking, (3) significant airway pressure changes or >15% reduction in compliance (CRS=VT/DP), and (4) before extubation. Receives: Procedure: Standard PEEP (8 cmH₂O) |
| Control Group - Standard Intraoperative PEEP | No intervention | PEEP will be set to currently accepted settings for intraoperative PEEP=8cmH2O. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral Oxygen Saturation (SpO₂) Following Extubation
Peripheral oxygen saturation (SpO₂) will be measured by pulse oximetry at least every 15 minutes during the first hour following extubation. SpO₂ will be recorded as a percentage (%).
Measured: First hour following extubation (assessed at least every 15 minutes)
Fraction of Inspired Oxygen (FiO₂) Following Extubation
Fraction of inspired oxygen (FiO₂) will be recorded at least every 15 minutes during the first hour following extubation. FiO₂ will be recorded as a percentage (%).
Measured: First hour following extubation (assessed at least every 15 minutes)
Secondary outcomes (3)
Highest Severity of Postoperative Pulmonary Complication (PPC)
Highest severity grade of any postoperative pulmonary complication (PPC) experienced by the participant, assessed using the study-defined PPC severity classification.
Measured: Postoperative Day 7 or hospital discharge, whichever occurs first
Incidence of Grade 3 and Grade 4 Postoperative Pulmonary Complications
Number of participants who experience Grade 3 or Grade 4 postoperative pulmonary complications (PPCs) based on the study-defined PPC severity classification.
Measured: Within 30 days after surgery
Duration of Postoperative Respiratory Support
Duration of postoperative supplemental oxygen therapy and/or other respiratory support, including noninvasive or invasive respiratory support, measured from initiation to discontinuation.
Measured: From surgery until discontinuation of supplemental oxygen therapy and/or respiratory support, up to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start29 Jul 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcos Vidal Melo, Principal investigator, University of Texas Medial Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774065
- Sponsor's protocol ID
- 25-0341
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing Post-Operative Pulmonary Complications in Patients With a BMI =35 kg/m2 Undergoing Robotic-Assisted or Conventional Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT07774065
- Acronym / sponsor ID
- 25-0341
- Conditions
- Obese
- Keywords
- Robotic Surgery, Body Mass Index (BMI) ≥ 35 kg/m2, Laparoscopic Surgery, Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 29 Jul 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 19 Aug 2026 (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 evaluate whether an intraoperative positive end-expiratory pressures (PEEP) setting strategy aimed at minimizing the mechanical power delivered to the lungs via transpulmonary pressure improves postoperative outcomes in obese patients undergoing conventional laparoscopic or robotic-assisted surgery. The objectives are to determine whether this strategy reduces immediate postoperative hypoxemia, and to assess whether it mitigates lung injury as reflected by relevant blood biomarkers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transpulmonary Pressure-Guided Individualized PEEP | Experimental | Procedure: Standard PEEP (8 cmH₂O)A transpulmonary-guided individualized positive end-expiratory pressure (PEEPPTP) will be set as follows: (A) The intervention is initiated by a recruitment maneuver consisting of 5 cmH2O-stepwise (30 sec) PEEP increases until either maximum PEEP=30 cmH2O or end-inspiratory PTP>25 cmH2O is reached. Settings: volume-controlled ventilation, VT=7ml/kg, I:E=1:1, inspiratory pause=20%, RR=10bpm, FiO2=80%. (B) Following recruitment, PEEP will be set to the value used immediately before the recruitment maneuver and PEso-EE assessed. PEEPPTP=PEso-EE+1-2 cmH2O. (C) PEEP will then be set for 30 sec at the highest value achieved during recruitment, followed by (D) PEEPPTP. Individualized PEEP-setting will be performed after: (1) induction of anesthesia, (2) pneumoperitoneum and final surgical position, including Trendelenburg and robot docking, (3) significant airway pressure changes or >15% reduction in compliance (CRS=VT/DP), and (4) before extubation. |
| Control Group - Standard Intraoperative PEEP | No intervention | –PEEP will be set to currently accepted settings for intraoperative PEEP=8cmH2O. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- Body Mass Index (BMI) ≥ 35 kg/m2;
- Scheduled for laparoscopic surgery expected to exceed 2h (from incision to closure) under general anesthesia, as determined pre-operatively by the attending surgeon and surgical team based on typical scheduling estimates, prior experience, procedure type, planned surgical approach, and patient-specific factors.
Key exclusion criteria (15 listed)
- Previous lung surgery;
- Invasive mechanical ventilation for >30 minutes within the last 30 days prior to surgery;
- Receipt of immunosuppressive medication (chemotherapy or radiotherapy) up to two months prior to surgery;
- Neurological procedures or cardiac surgery;
- Need for one-lung ventilation or planned re-intubation following surgery;
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 |
|---|---|---|
| Standard PEEP (8 cmH₂O)Participants will receive standard intraoperative mechanical ventilation with a fixed positive end-expiratory pressure (PEEP) of 8 cmH₂O maintained throughout the surgical procedure. | Procedure or surgery | Transpulmonary Pressure-Guided Individualized PEEP |
Primary outcome
Peripheral Oxygen Saturation (SpO₂) Following Extubation
Time frame: First hour following extubation (assessed at least every 15 minutes)
Peripheral oxygen saturation (SpO₂) will be measured by pulse oximetry at least every 15 minutes during the first hour following extubation. SpO₂ will be recorded as a percentage (%).
Fraction of Inspired Oxygen (FiO₂) Following Extubation
Time frame: First hour following extubation (assessed at least every 15 minutes)
Fraction of inspired oxygen (FiO₂) will be recorded at least every 15 minutes during the first hour following extubation. FiO₂ will be recorded as a percentage (%).
3 secondary outcomes
Highest Severity of Postoperative Pulmonary Complication (PPC)
Time frame: Postoperative Day 7 or hospital discharge, whichever occurs first
Incidence of Grade 3 and Grade 4 Postoperative Pulmonary Complications
Time frame: Within 30 days after surgery
Duration of Postoperative Respiratory Support
Time frame: From surgery until discontinuation of supplemental oxygen therapy and/or respiratory support, up to 30 days postoperatively
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 19 Aug 2026.
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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.
Marcos Vidal Melo principal investigator
University of Texas Medial Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard PEEP (8 cmH₂O) in people with Obese, run by The University of Texas Medical Branch, Galveston 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 3 inclusion and 15 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 19 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 Negar Motayagheni ((409)772-1011, nemotaya@utmb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral Oxygen Saturation (SpO₂) Following Extubation (time frame: First hour following extubation (assessed at least every 15 minutes)). The study lists 2 primary outcomes in all. 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 19 Aug 2026.