NCT07203781 PEEP-induced Effects on Respiratory dRivE and EFfort
| NCT ID | NCT07203781 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Radboud University Medical Center |
| Condition | ARDS (Moderate or Severe) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-09-02 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-09-02 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * Age \> 18 years * Acute hypoxemic respiratory failure (AHRF) with a PaO2/FiO2-ratio ≤ 200 * Patient on invasive assisted mechanical ventilation in pressure support mode exhibiting valid inspiratory efforts (occlusion pressure \> 5 cmH2O). Exclusion Criteria: * Pre-existent neuromuscular disease * History of chronic respiratory failure requiring long-term oxygen therapy * Muscle paralysis * Pneumothorax * Contra-indication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode placement) * Contra-indications 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).
Contact & Investigator
Jonne Doorduin, PhD
PRINCIPAL INVESTIGATOR
Radboud University Medical Center
Frequently Asked Questions
Who can join the NCT07203781 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ARDS (Moderate or Severe). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07203781 currently recruiting?
Yes, NCT07203781 is actively recruiting participants. Contact the research team at tommaso.rosa@radboudumc.nl for enrollment information.
Where is the NCT07203781 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands.
Who is sponsoring the NCT07203781 clinical trial?
NCT07203781 is sponsored by Radboud University Medical Center. The principal investigator is Jonne Doorduin, PhD at Radboud University Medical Center. The trial plans to enroll 20 participants.