- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07536464
PEEP Strategies and Mechanical Power in Robotic Surgery
Comparison of Incremental, Decremental, and Fixed PEEP Strategies on Mechanical Power and Postoperative Oxygenation in Robotic Surgery: A Prospective Randomized Controlled Trial
Robotic surgery requires pneumoperitoneum and steep Trendelenburg positioning, which significantly impair respiratory mechanics and increase the risk of postoperative pulmonary complications.
Positive end-expiratory pressure (PEEP) is a key determinant of lung recruitment; however, fixed PEEP strategies may not be optimal for all patients. Individualized PEEP titration strategies, including incremental and decremental approaches, may better optimize lung mechanics.
This randomized controlled trial aims to compare the effects of incremental, decremental, and fixed PEEP strategies on cumulative mechanical power (MP-AUC) and postoperative oxygenation in patients undergoing robotic surgery.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age>= 18
- ASA I-III
- Elective robotic surgery
Exclusion Criteria:
COPD GOLD ≥2
- Restrictive lung disease
- BMI >40 kg/m²
- Heart failure
- Preoperative oxygen requirement
- Need for postoperative mechanical ventilation
- Refusal to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Fixed PEEP
Ventilation with constant PEEP of 5 cmH₂O throughout surgery.
|
Patients receive mechanical ventilation with a constant positive end-expiratory pressure (PEEP) of 5 cmH₂O throughout the surgical procedure.
PEEP is gradually decreased from a higher level to determine the optimal PEEP associated with the lowest driving pressure or lowest mechanical power, and this level is maintained during surgery.
PEEP is gradually increased from a lower level to identify the optimal PEEP corresponding to the lowest driving pressure or mechanical power, and this level is maintained during surgery.
|
|
Experimental: Decremental PEEP
PEEP is gradually decreased to identify the level associated with the lowest driving pressure or lowest mechanical power.
|
Patients receive mechanical ventilation with a constant positive end-expiratory pressure (PEEP) of 5 cmH₂O throughout the surgical procedure.
PEEP is gradually decreased from a higher level to determine the optimal PEEP associated with the lowest driving pressure or lowest mechanical power, and this level is maintained during surgery.
PEEP is gradually increased from a lower level to identify the optimal PEEP corresponding to the lowest driving pressure or mechanical power, and this level is maintained during surgery.
|
|
Experimental: Incremental PEEP
PEEP is gradually increased to determine the optimal level corresponding to the lowest driving pressure or mechanical power.
|
Patients receive mechanical ventilation with a constant positive end-expiratory pressure (PEEP) of 5 cmH₂O throughout the surgical procedure.
PEEP is gradually decreased from a higher level to determine the optimal PEEP associated with the lowest driving pressure or lowest mechanical power, and this level is maintained during surgery.
PEEP is gradually increased from a lower level to identify the optimal PEEP corresponding to the lowest driving pressure or mechanical power, and this level is maintained during surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative Mechanical Power (MP-AUC)
Time Frame: During surgery (from intubation to extubation)
|
Total energy delivered to the respiratory system during surgery
|
During surgery (from intubation to extubation)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
PaO₂/FiO₂ ratio
Time Frame: Intraoperative period and postoperative period (within 2 hours)
|
Intraoperative period and postoperative period (within 2 hours)
|
|
Oxygenation Index (OSI)
Time Frame: Postoperative 2 hours
|
Postoperative 2 hours
|
|
Postoperative Pulmonary Complications (PPC)
Time Frame: Within 7 postoperative days
|
Within 7 postoperative days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- E26-14833
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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