NCT07536464

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Apr 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Apr 2026Jun 2026

First Submitted

Initial submission to the registry

April 11, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

16 days

First QC Date

April 11, 2026

Last Update Submit

April 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cumulative Mechanical Power (MP-AUC)

    Total energy delivered to the respiratory system during surgery

    During surgery (from intubation to extubation)

Secondary Outcomes (3)

  • PaO₂/FiO₂ ratio

    Intraoperative period and postoperative period (within 2 hours)

  • Oxygenation Index (OSI)

    Postoperative 2 hours

  • Postoperative Pulmonary Complications (PPC)

    Within 7 postoperative days

Study Arms (3)

Fixed PEEP

ACTIVE COMPARATOR

Ventilation with constant PEEP of 5 cmH₂O throughout surgery.

Procedure: Fixed PEEP VentilationProcedure: Decremental PEEP StrategyProcedure: Incremental PEEP Strategy

Decremental PEEP

EXPERIMENTAL

PEEP is gradually decreased to identify the level associated with the lowest driving pressure or lowest mechanical power.

Procedure: Fixed PEEP VentilationProcedure: Decremental PEEP StrategyProcedure: Incremental PEEP Strategy

Incremental PEEP

EXPERIMENTAL

PEEP is gradually increased to determine the optimal level corresponding to the lowest driving pressure or mechanical power.

Procedure: Fixed PEEP VentilationProcedure: Decremental PEEP StrategyProcedure: Incremental PEEP Strategy

Interventions

Patients receive mechanical ventilation with a constant positive end-expiratory pressure (PEEP) of 5 cmH₂O throughout the surgical procedure.

Decremental PEEPFixed PEEPIncremental PEEP

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.

Decremental PEEPFixed PEEPIncremental PEEP

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.

Decremental PEEPFixed PEEPIncremental PEEP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\>= 18
  • ASA I-III
  • Elective robotic surgery

You may not qualify if:

  • COPD GOLD ≥2
  • Restrictive lung disease
  • BMI \>40 kg/m²
  • Heart failure
  • Preoperative oxygen requirement
  • Need for postoperative mechanical ventilation
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assos prof

Study Record Dates

First Submitted

April 11, 2026

First Posted

April 17, 2026

Study Start

April 15, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04