Actively Recruiting
PEEP-induced Effects on Respiratory dRivE and EFfort
Led by Radboud University Medical Center · Updated on 2025-11-17
20
Participants Needed
1
Research Sites
52 weeks
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
Rationale: In patients with acute hypoxemic respiratory failure (AHRF), preserving spontaneous breathing during mechanical ventilation offers physiological benefits, but also carries risks. While spontaneous breathing improves gas exchange and limits diaphragm atrophy, strong inspiratory efforts may worsen lung and diaphragm injury. Balancing these factors requires refined and tailored strategies, such as the modulation of PEEP. However, the impact of PEEP on neural respiratory drive and inspiratory effort is very heterogenous, and these two entities have only been studied separately in limited subsets of patients and healthy subjects. Additionally, it remains unclear whether the major determinant of PEEP-induced changes in respiratory drive and effort is represented by variations in diaphragm geometry, lung compliance, or by the presence of expiratory muscles recruitment, which may counteract its effect. Objective: The primary objective is to determine the effect of PEEP on diaphragm neuromechanical efficiency (i.e. an index of neural respiratory drive and inspiratory effort) in patients with acute hypoxemic respiratory failure during invasive assisted mechanical ventilation. The secondary objective is to determine the major physiological contributors to PEEP-mediated changes in diaphragm neuromechanical efficiency. Study design: Prospective, physiological study. Study population: Invasively mechanically ventilated adult patients admitted to the ICU. Intervention: For each patient, six different PEEP levels (15-12-10-8-5-2 cmH2O) will be tested during a decremental PEEP trial. During each step, neural respiratory drive, inspiratory effort, expiratory muscle activity, lung inflation pattern through electrical impedance tomography, respiratory muscle geometry and function through ultrasound and surface EMG, gas exchange and hemodynamics data will be collected. Main study parameters/endpoints: The primary outcome of the study will be the evaluation of PEEP-mediated changes in diaphragm neuromechanical efficiency (NME).
CONDITIONS
Official Title
PEEP-induced Effects on Respiratory dRivE and EFfort
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Acute hypoxemic respiratory failure with PaO2/FiO2 ratio less than or equal to 200
- Receiving invasive assisted mechanical ventilation in pressure support mode showing valid inspiratory efforts (occlusion pressure greater than 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
- Contraindications to electrical impedance tomography monitoring such as burns, pacemaker, or thoracic wounds limiting electrode placement
- Contraindications for EAdi or oesophageal balloon catheter placement such as history of gastric bypass surgery, gastro-oesophageal junction surgery, oesophageal stricture, recent upper gastrointestinal hemorrhage, or known/suspected varices
AI-Screening
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Trial Site Locations
Total: 1 location
1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525 GA
Actively Recruiting
Research Team
T
Tommaso Rosà, M.D.
CONTACT
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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