NCT07277244

Low-Intensity Mechanical Ventilation in the Operating Room: a Pilot Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to assess whether a bundle of protective low-intensity mechanical ventilation interventions reduces perioperative atelectasis and postoperative pulmonary complications, compared with standard care in a robot-assisted surgical setting. The feasibility of this ventilation bundle will also be assessed.

Detailed description

The investigators hypothesize that protective low-intensity mechanical ventilation during robot-assisted surgery reduces perioperative atelectasis and postoperative pulmonary complications.

Conditions

• Robotic Surgery
• Post Operative Pulmonary Complications

Interventions

Type	Name	Description
DEVICE	Low Intensity Mechanical Ventilation	A bundle of protective low-intensity mechanical ventilation strategies will be applied throughout the procedure: 1. Recruitment maneuver 2. Tidal volume set to 8 ml/kg predicted body weight (PBW) and stepwise adjustment to achieve a driving pressure (Plateau pressure - PEEP) \< 13 cmH2O with a minimum tidal volume of 5ml/kg PBW 3. Respiratory rate adjustment to maintain a target end-tidal carbon dioxide concentration (etCO₂) between 45 and 55 mmHg. 4. Reassessment and adaptation after Trendelenburg positioning and pneumoperitoneum. 5. Re-adjustment of Tidal Volume and PEEP ventilator settings to (2.) after exsufflation and return to the supine position. FiO₂ set to 70% during the washout phase of the inhalational anesthetic until extubation.

Timeline

• Start date: 2026-04-02
• Primary completion: 2026-10-31
• Completion: 2027-03-31
• First posted: 2025-12-11
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study