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

NCT ID: NCT07277244

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2027-02-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type: EXPERIMENTAL

Low Intensity Mechanical Ventilation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Maximilian S Schaefer

Associate Professor of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Arian Karimitar, PhD

Role: CONTACT

akarimit@bidmc.harvard.edu

6176328056

Maximilian S. Schaefer, MD PhD

Role: CONTACT

msschaef@bidmc.harvard.edu

References

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.

Reference Type: RESULT

PMID: 29793604 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25018668 (View on PubMed)

Other Identifiers

2025P000986

Identifier Type: -

Identifier Source: org_study_id