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

Beth Israel Lahey Health

Status: Not yet enrolling

Conditions: Post Operative Pulmonary Complications; Robotic Surgery

Treatments: Other: Low Intensity Mechanical Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT07277244

2025P000986

Details and patient eligibility

About

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.

Full description

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Control

No Intervention group

Description:

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 group

Description:

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

Treatment:

Other: Low Intensity Mechanical Ventilation