NCT04241874

PEEP and Spontaneous Breathing During ARDS

Effects of Positive End-expiratory Pressure With and Without Inspiratory Synchronization During Moderate to Severe ARDS

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, physiological study to systematically assess the effects of high positive end-expiratory pressure (PEEP) with and without inspiratory synchronization in patients with moderate to severe acute respiratory distress syndrome (ARDS) exhibiting intense inspiratory effort while on assisted ventilation.

Detailed 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 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.

Conditions

• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
OTHER	Mechanical Ventilation	Respiratory support through mechanical ventilator

Timeline

• Start date: 2021-05-01
• Primary completion: 2022-06-15
• Completion: 2022-06-15
• First posted: 2020-01-27
• Last updated: 2022-09-07

Locations

1 site across 1 country: Italy