PEEP and Spontaneous Breathing During ARDS
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Respiratory Distress Syndrome
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This prospective, physiological, randomized, cross-over study will be conducted in the 20-bed general ICU of the Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy. Patients with ARDS will be screened for eligibility. ARDS will be defined according to the Berlin Definition. Intubated...
This prospective, physiological, randomized, cross-over study will be conducted in the 20-bed general ICU of the Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy. Patients with ARDS will be screened for eligibility. ARDS will be defined according to the Berlin Definition. Intubated patients fulfilling ARDS criteria, undergoing assisted ventilation as per clinical decision and exhibiting intense inspiratory effort (occlusion pressure equal or greater than 13 cmH2O) will be enrolled. Patients will be placed in a 30°-45° head up position during all study phases. According to our institution protocol, pressure support setting will be selected by the attending physician to target a predefined tidal volume range of 6-8 mL/kg of predicted body weight (PBW) (female PBW [kg] = 45.5 + 0.91 [cm of height - 152.4]; male PBW [kg] = 50 + 0.91 [cm of height - 152.4]).The lowest pressure support level allowed will be 7 cmH2O, even if Vt <8 ml/Kg PBW is not achieved. In each patient, four different ventilator settings will be applied in a random order. Each step will last 45 minutes.
Tracking Information
- NCT #
- NCT04241874
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Giuseppe Bello, MD Fondazione Policlinico A. Gemelli IRCCS Study Director: Massimo Antonelli, MD Fondazione Policlinico A. Gemelli IRCCS