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NCT Number: NCT07774065

Mechanical Ventilation in Obese Surgical Patients

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Medical Branch, Galveston

Galveston, Texas, 77555, United States

Location status: Recruiting

Location contact

Negar Motayagheni

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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

Treatment and study plan

Standard PEEP (8 cmH₂O)

Procedure

Participants will receive standard intraoperative mechanical ventilation with a fixed positive end-expiratory pressure (PEEP) of 8 cmH₂O maintained throughout the surgical procedure.

Primary outcomes

  1. 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 (%).

  2. 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 (%).

Secondary outcomes

  1. Highest Severity of Postoperative Pulmonary Complication (PPC)

    Time frame: Postoperative Day 7 or hospital discharge, whichever occurs first

    Highest severity grade of any postoperative pulmonary complication (PPC) experienced by the participant, assessed using the study-defined PPC severity classification.

  2. Incidence of Grade 3 and Grade 4 Postoperative Pulmonary Complications

    Time frame: Within 30 days after surgery

    Number of participants who experience Grade 3 or Grade 4 postoperative pulmonary complications (PPCs) based on the study-defined PPC severity classification.

  3. Duration of Postoperative Respiratory Support

    Time frame: From surgery until discontinuation of supplemental oxygen therapy and/or respiratory support, up to 30 days postoperatively

    Duration of postoperative supplemental oxygen therapy and/or other respiratory support, including noninvasive or invasive respiratory support, measured from initiation to discontinuation.

Other outcomes

  1. Major Extrapulmonary Complications

    Time frame: Within 30 days after surgery

    Number of participants experiencing major extrapulmonary postoperative complications.

  2. All-Cause Mortality

    Time frame: Postoperative Day 30

    Number of all-cause mortality following surgery.

  3. Length of Stay in the Post-Anesthesia Care Unit (PACU)

    Time frame: At 3 hours after PACU admission

    Duration of stay in the post-anesthesia care unit following surgery.

  4. Unexpected Intensive Care Unit (ICU) Admission

    Time frame: During the index hospitalization, up to 30 days after surgery

    Number of participants requiring an unplanned admission to the Intensive Care Unit following surgery.

  5. Hospital Length of Stay

    Time frame: Day of surgery, postoperative Day 7, and postoperative Day 30, or discharge, whichever occurs first

    Duration of hospitalization following surgery.

  6. ICU Length of Stay

    Time frame: Day of surgery, postoperative Day 7, and postoperative Day 30, or discharge, whichever occurs first

    Duration of stay in the Intensive Care Unit among participants admitted to the ICU postoperatively.

  7. Immediate Postoperative Adverse Events

    Time frame: Within 24 hours after surgery

    Number of adverse events occurring within 24 hours after surgery, including pneumothorax, hypoxemia, hypotension, use of vasoactive medications, and volume replacement.

  8. End-Inspiratory Transpulmonary Pressure Greater Than 25 cmH₂O

    Time frame: During surgery

    Rate of participants with end-inspiratory transpulmonary pressure (PTP) greater than 25 cmH₂O during the perioperative period.

Study contacts

Contact information is provided by the study sponsor or research team.

Congli Zeng, MD, PhD

CONTACT

[email protected]

(409)772-1011

Negar Motayagheni

CONTACT

[email protected]

(409)772-1011

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Official study title

Minimizing Post-Operative Pulmonary Complications in Patients With a BMI =35 kg/m2 Undergoing Robotic-Assisted or Conventional Laparoscopic Surgery

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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