NCT06438198 Early Switch from Controlled to Assisted Ventilation
| NCT ID | NCT06438198 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Acute Hypoxemic Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-09-15 |
| Primary Completion | 2026-04 |
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 2024-09-15 with a primary completion date of 2026-04.
⚠ 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
The goal of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio \< 200 mmHg). The intervention is that participants will be switched from controlled to assisted ventilation when PaO2/FiO2 ratio \> 200 mmHg. The primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch.
Eligibility Criteria
Inclusion Criteria: * 18 years old * Written informed consent from a legal representative * Mechanical ventilation via an endotracheal tube * Acute hypoxemic respiratory failure with PaO2/FiO2 ratio \< 200 mmHg * Under continuous sedation with or without paralysis Exclusion Criteria: * Expected mechanical ventilation duration of \<48 hours * Pure chronic obstructive pulmonary disease exacerbation * Pre-existent respiratory muscle disease * Contraindication to EIT monitoring (as per clinical protocol, e.g. pacemaker, burns or thoracic wounds limiting electrode placement) * Contra-indications to oesophageal manometry (as per clinical protocol, e.g., recent oesophageal surgery, oesophageal varices, severe bleeding disorders) * Known pregnancy * Anticipating withdrawal of life support and/or shift to palliation as the goal of care
Contact & Investigator
Annemijn Jonkman, PhD
PRINCIPAL INVESTIGATOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT06438198 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Hypoxemic Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06438198 currently recruiting?
Yes, NCT06438198 is actively recruiting participants. Contact the research team at a.jonkman@erasmusmc.nl for enrollment information.
Where is the NCT06438198 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT06438198 clinical trial?
NCT06438198 is sponsored by Erasmus Medical Center. The principal investigator is Annemijn Jonkman, PhD at Erasmus Medical Center. The trial plans to enroll 20 participants.