Low-Intensity Mechanical Ventilation for Pulmonary Complications
(VIOLET Trial)
AK
MS
Overseen ByMaximilian S. Schaefer, MD PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Beth Israel Deaconess Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
Inclusion Criteria
I am an adult scheduled for a robot-assisted surgery in my abdomen or pelvis that will last at least 2 hours under general anesthesia, with plans to remove the breathing tube after surgery.
Exclusion Criteria
Known pregnancy
Pre-existing intubation or tracheostomy
Contraindications for electrical impedance tomography (EIT): inability to place EIT belt, presence of an active electronic implantable device (e.g., pacemaker, ICD)
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What Are the Treatments Tested in This Trial?
Interventions
- Low Intensity Mechanical Ventilation
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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 II: ControlActive Control1 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical Center
Lead Sponsor
Trials
872
Recruited
12,930,000+
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