Clinical trial Recruiting at 1 site Interventional Ages 18 and up

How changing PEEP affects breathing drive and effort during pressure‑support ventilation

Official title: Unraveling PEEP-induced Effects on Respiratory dRivE and EFfort in Acute Hypoxemic Respiratory Failure: the REEF Study

Run by Radboud University Medical Center · NCT07203781 · Data updated 2026-11-12

We will test whether changing PEEP levels changes neural respiratory drive and inspiratory effort in adults on pressure‑support ventilation for moderate‑to‑severe ARDS or acute hypoxemic respiratory failure.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment20 (estimated)
SponsorRadboud University Medical Center
Academic / other
Locations1 site (Nijmegen, Gelderland)
StatusRecruiting
StartedSeptember 2, 2025
Main results expectedSeptember 2026
Study endsSeptember 2026
Registry record updatedNovember 17, 2025
Trial IDNCT07203781 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults over 18 with acute hypoxemic respiratory failure (PaO2/FiO2 ≤ 200) who are on invasive pressure‑support ventilation with valid spontaneous inspiratory efforts (occlusion pressure > 5 cmH2O) and who can tolerate EIT and oesophageal/EAdi monitoring are ideal candidates.

Probably not a fit

Patients with pre‑existing neuromuscular disease, chronic respiratory failure requiring long‑term oxygen, ongoing muscle paralysis, pneumothorax, or contraindications to EIT or oesophageal/EAdi catheter placement are unlikely to qualify or benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an interventional physiologic protocol that changes positive end‑expiratory pressure (PEEP) in invasively ventilated adults with acute hypoxemic respiratory failure (PaO2/FiO2 ≤ 200) who are breathing with pressure support and have measurable inspiratory efforts. While patients remain on assisted ventilation, investigators will record neural and mechanical measures of breathing (for example EAdi, oesophageal pressure, and electrical impedance tomography) as PEEP is adjusted to observe short‑term effects. The protocol aims to define how PEEP alters neural respiratory drive and inspiratory effort and to explore whether these effects are driven by diaphragm geometry, lung compliance, or recruitment of expiratory muscles. Procedures are performed at a single center with advanced physiologic monitoring during brief PEEP interventions.

Why it matters

Potential benefit: If successful, the results could help clinicians choose PEEP settings that reduce harmful inspiratory effort and better protect both lung and diaphragm function.

How similar studies have gone: Previous small physiologic studies in volunteers and limited patient groups have shown mixed and heterogeneous PEEP effects on drive and effort, so this detailed simultaneous‑measurement approach is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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).

Where it's running

  • Radboudumc
    Nijmegen, Gelderland, Netherlands
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.