Mechanical Ventilation in Obese Surgical Patients

ConditionObese

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorThe University of Texas Medical Branch, Galveston

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

10 Participants

are divided into 2 treatment groups

Group A: Transpulmonary Pressure-Guided Individualized PEEPExperimental treatment 1 intervention

Group B: Control Group - Standard Intraoperative PEEPNo intervention 0 interventions

Trial outcomes

Primary outcomes

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 (%).

Time frame

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 (%).

Time frame

First hour following extubation (assessed at least every 15 minutes)

Secondary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

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

Other outcomes

Major Extrapulmonary Complications

Number of participants experiencing major extrapulmonary postoperative complications.

Time frame

Within 30 days after surgery

All-Cause Mortality

Number of all-cause mortality following surgery.

Time frame

Postoperative Day 30

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

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

Time frame

At 3 hours after PACU admission

Unexpected Intensive Care Unit (ICU) Admission

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

Time frame

During the index hospitalization, up to 30 days after surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Medical Branch, Galveston

Lead sponsor

Source ClinicalTrials.gov

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