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

NCT07277244 | Enrolling By Invitation FDA Device

• 1 other identifier: 2025P000986
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Robotic Surgery; Post Operative Pulmonary Complications

Keywords

Lung protective ventilation; Electric Impedance Tomography (EIT)

Outcome Measures

Primary Outcomes (1)

• ΔEELV between baseline and after extubation before leaving the operating room.

  Change in end-expiratory lung volume (EELV), measured using electrical impedance tomography between baseline and after extubation before leaving the operating room.

  Perioperative Day 0: From pre-intubation baseline in the operating room (prior to induction of anesthesia) to the first post-extubation EIT assessment (within 10 min after extubation on Day 0).

Secondary Outcomes (19)

• Proportion of patients with postoperative pulmonary complications at day 7

  This secondary outcome will be assessed in the time between day of surgery until 7 days after the day of surgery

• Change in right-ventricular systolic function (TAPSE, mm) from pre-intubation baseline to first post-extubation echocardiogram

  Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, just before extubation

• Change in right-ventricular fractional area change (RV-FAC, %) from pre-intubation baseline to first post-extubation echocardiogram

  Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, just before extubation

• Change in left ventricular ejection fraction (LVEF, %) from pre-intubation baseline to first post-extubation echocardiogram

  Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, just before extubation

• Change in estimated pulmonary artery systolic pressure (PASP, mmHg) from pre-intubation baseline to first post-extubation echocardiogram

  Perioperative Day 0: before anesthesia, after intubation, after PEEP/TV/RR titration, just before extubation

Study Arms (2)

Control

NO INTERVENTION

A guided standard of care protocol will be applied in the control group. This includes a PEEP of 5 cmH₂O, with adjustment by the anesthesia provider if SpO₂ falls below 96% or whenever deemed clinically necessary, a tidal volume of 6-10 mL/kg predicted body weight, and a respiratory rate adjusted to maintain end-tidal CO₂ between 35 and 45 mmHg throughout anesthesia. FiO₂ will be set to 100% during the washout phase at the end of surgery to limit resorption atelectasis.

Intervention

EXPERIMENTAL

A bundle of protective low-intensity mechanical ventilation strategies will be applied throughout the procedure. All interventions consist of modification of ventilator settings.

Device: Low Intensity Mechanical Ventilation

Interventions

Low Intensity Mechanical Ventilation DEVICE

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing elective intra-abdominal or pelvic robot-assisted surgery with a planned duration of at least 2 hours, under general anesthesia with planned extubation at the end of the procedure

You may not qualify if:

• Known pregnancy
• Pre-existing intubation or tracheostomy
• Contraindications for esophageal manometry: severe midface trauma or recent nasal surgery, esophageal varices, recent gastric or esophageal surgery
• Contraindications for electrical impedance tomography (EIT): inability to place EIT belt, presence of an active electronic implantable device (e.g., pacemaker, ICD)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• Schaefer MS, Treschan TA, Gauch J, Neukirchen M, Kienbaum P. Influence of xenon on pulmonary mechanics and lung aeration in patients with healthy lungs. Br J Anaesth. 2018 Jun;120(6):1394-1400. doi: 10.1016/j.bja.2018.02.064. Epub 2018 Apr 13.

  PMID: 29793604 RESULT

• Schaefer MS, Wania V, Bastin B, Schmalz U, Kienbaum P, Beiderlinden M, Treschan TA. Electrical impedance tomography during major open upper abdominal surgery: a pilot-study. BMC Anesthesiol. 2014 Jul 5;14:51. doi: 10.1186/1471-2253-14-51. eCollection 2014.

  PMID: 25018668 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesia

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 11, 2025
• Study Start: April 2, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1)