Actively Recruiting
Unraveling PEEP-induced Effects on Respiratory dRivE and EFfort in Acute Hypoxemic Respiratory Failure: the REEF Study
Led by Radboud University Medical Center · Updated on 2025-11-17
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Radboud University Medical Center
Lead Sponsor
C
Catholic University of the Sacred Heart
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with acute hypoxemic respiratory failure (AHRF) who require invasive mechanical ventilation. This study aims to understand how different levels of positive end-expiratory pressure (PEEP) affect the diaphragm's neuromechanical efficiency, which reflects neural respiratory drive and inspiratory effort. The study also seeks to identify the main factors influencing PEEP-related changes in diaphragm function, lung mechanics, and muscle activity. The study involves testing six different PEEP levels (15, 12, 10, 8, 5, and 2 cmH2O) in a decreasing sequence during a trial. Each PEEP level is maintained for 30 minutes, with measurements taken during the last 10 minutes of each step. Researchers will collect data on respiratory muscle function using ultrasound and surface electromyography, lung inflation patterns through electrical impedance tomography, muscle activity, gas exchange, and hemodynamic parameters. Participants will be adults on invasive assisted mechanical ventilation in pressure support mode with adequate inspiratory effort. Throughout the study, multiple assessments will be performed at each PEEP level, including diaphragm thickening fraction, expiratory muscle activity, gastric pressure, and various respiratory mechanics. The primary outcome is the change in diaphragm neuromechanical efficiency, while secondary outcomes include changes in inspiratory effort, neural respiratory drive, lung mechanics, and gas exchange. The total participation time varies per patient as measurements are taken during the PEEP trial steps.
CONDITIONS
Brief Title
PEEP-induced Effects on Respiratory dRivE and EFfort
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Acute hypoxemic respiratory failure with PaO2/FiO2 ratio ≤ 200
- On invasive assisted mechanical ventilation in pressure support mode with valid inspiratory efforts (occlusion pressure > 5 cmH2O)
You will not qualify if you...
- Pre-existing neuromuscular disease
- History of chronic respiratory failure requiring long-term oxygen therapy
- Muscle paralysis
- Pneumothorax
- Contraindication to electrical impedance tomography monitoring (e.g., burns, pacemaker, thoracic wounds limiting electrode placement)
- Contraindications for EAdi or oesophageal balloon catheter placement (e.g., history of gastric bypass surgery, gastro-oesophageal junction surgery, oesophageal stricture, recent upper gastrointestinal hemorrhage, or known/suspected varices)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Approximately 3 hours
Participants undergo testing at six different PEEP levels, each lasting 30 minutes, to measure respiratory drive, inspiratory effort, muscle activity, lung function, gas exchange, and hemodynamics.
1 in-person visit during which all PEEP levels are tested sequentially
Trial Site Locations
Total: 1 location
1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525 GA
Actively Recruiting
Research Team
T
Tommaso Rosà, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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