An observational study in Diaphragm Dysfunction, Weaning Invasive Mechanical Ventilation and Respiratory Failure, ICU, sponsored by Radboud University Medical Center. Not yet recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Radboud University Medical Center · Observational
Among 37 studies in Respiratory Insufficiency with a site in Netherlands — 8 open to participants now, 10 under way, 1 of them phase 3. Respiratory Insufficiency · Netherlands.
Among the 37 studies in Respiratory Insufficiency with a site in Netherlands, this one is the 6th largest by planned enrollment of the 12 observational ones, is one of 2 that started in 2026, is one of 12 observational ones, and was the 37th registered.
1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.
This study's planned enrollment of 112 is above the median of 100 across 455 observational studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →8 of the 37 studies in Respiratory Insufficiency with a site in Netherlands are open now, in 12 countries. Each count lists the studies.
Of the 178 Respiratory Insufficiency studies recruiting now, 134 (75%) set no upper age limit and 18 (10%) stop at 75 or younger; 21 take children under 18; 19 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →37 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2026.
Median enrollment 100 across the 25 interventional studies, 94 across the 12 observational. Of the 22 that completed or were terminated, 5 (23%) have results posted.
7 of 37 have an industry lead sponsor. The 10 most frequent:
Radboud University Medical Center is the lead sponsor of 986 studies on the registry; 136 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Radboud University Medical Center has 3 studies filed under Respiratory Insufficiency — fewer than ten, so there is no comparison to draw.
2 of the studies in Respiratory Insufficiency with a site in Netherlands that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06776939Henrik EndemanPhysiological Effect High-flow Tracheal Oxygen on Viscosity of Airway Mucus and Respiratory Effort in Patients Weaning From Invasive Mechanical Ventilation | 2026-12-31 |
| NCT05947955BioAegis Therapeutics Inc.Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS) | 2027-10-01 |
Among the 37 studies in Respiratory Insufficiency with a site in Netherlands, from their registry updates:
Rationale:
Patients with invasive mechanical ventilation (IMV) frequently develop diaphragm dysfunction and experience difficult weaning. Recent ex vivo work suggests that a subset of mechanically ventilated ICU patients may exhibit diaphragm hibernation, an energy conserving myosin state that reduces force generation and may lead to a reversible increase in diaphragm strength over time. However, it is unknown whether diaphragm hibernation can be demonstrated in vivo during IMV and which clinical and biological factors are associated with this phenotype.
Objective:
Primary objective is to determine the driving factors (biomarkers) of diaphragm hibernation during IMV. Secondary objectives are to determine the proportion of ventilated critically ill patients who exhibit diaphragm hibernation during IMV, to investigate inflammatory and metabolic factors and other clinical exposures associated with diaphragm hibernation, and to explore associations between diaphragm hibernation and weaning related and survival outcomes.
Study design:
Prospective, observational, longitudinal cohort study.
Study population:
Adult ICU patients receiving IMV, expected to remain mechanically ventilated for at least 72 hours.
Intervention (if applicable):
Not applicable. This is an observational study. Study specific procedures consist of repeated phrenic nerve magnetic stimulation and additional blood sampling.
Main study parameters/endpoints:
The primary study parameter is the proportion of participants exhibiting diaphragm hibernation during IMV. Diaphragm hibernation is defined as an increase in stimulated twitch tracheal pressure (Ptr,stim), a measure of diaphragm strength, of at least 10% relative to baseline (Day 0-1) at any follow up assessment (Day 2, 3, 5, or 7) obtained before extubation or death. Ptr,stim will be assessed repeatedly on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Participant burden is limited and mainly consists of repeated phrenic nerve magnetic stimulation during a ventilator delivered end expiratory occlusion and additional blood sampling of 9.5 mL per time point, up to a total of 47.5 mL across the study period. Magnetic stimulation is non-invasive and expected discomfort is transient. Rare transient physiological changes may occur and measurements are performed under continuous ICU monitoring and will be postponed or omitted if considered unsafe or interfering with clinical care. Direct benefit for participants is limited, but the study may provide clinically relevant knowledge on diaphragm hibernation and its driving factors. The research questions are specific to diaphragm physiology during IMV in critically ill patients, therefore the study is group related and cannot be performed in a different population.
The study population consists of newly admitted adult ICU patients receiving invasive mechanical ventilation, in whom the first study assessment can be performed within 36 hours after initiation of IMV and who are expected to require IMV for at least 3 days.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients expected \> 3 days of invasive mechanical ventilation will be included in this study. Blood sample and diaphragm strength will be assessed repeatedly, until 7 days after initiation of invasive mechanical ventilation, extubation or death.
Blood C reactive protein level
C reactive protein will be assessed by blood sample.
Time frame: C reactive protein will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Blood procalcitonin level
Procalcitonin will be assessed by blood sample.
Time frame: Procalcitonin will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Blood metabolic biomarkers level
Metabolic biomarkers will be assessed by blood sample using OLINK Target 96 panel.
Time frame: Metabolic biomarkers will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Blood TNF-α level
TNF-α will be assessed by blood sample.
Time frame: TNF-α will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Blood IL-10 level
IL-10 will be assessed by blood sample.
Time frame: IL-10 will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Blood IL-8 level
IL-8 will be assessed by blood sample.
Time frame: IL-8 will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Blood IL-6 level
IL-6 will be assessed by blood sample.
Time frame: IL-6 will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Blood ferritin level
Ferritin will be assessed by blood sample.
Time frame: Ferritin will be assessed on Day 0-1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Proportion of participants exhibiting diaphragm hibernation during invasive mechanical ventilation
Diaphragm hibernation is defined as an increase in stimulated twitch tracheal pressure (Ptr,stim), a measure of diaphragm strength, of at least 10% relative to baseline (Day 0 to 1) at any follow up assessment (Day 2, 3, 5, or 7) obtained before extubation or death.
Time frame: Ptr,stim will be assessed repeatedly on Day 0 to 1, Day 2, Day 3, Day 5, and Day 7, or until extubation or death, whichever occurs first.
Number of days from intubation to successful extubation
Data about number of days from intubation to successful extubation will be retrieved from electronic medical records.
Time frame: Collected from study inclusion until Day 28, or ICU/hospital discharge or death, whichever occurs first
Number of days from first SBT to successful extubation
Data about number of days from first SBT to successful extubation will be retrieved from electronic medical records.
Time frame: Collected from study inclusion until Day 28, or ICU/hospital discharge or death, whichever occurs first
Incidence of weaning failure
Weaning failure is defined as SBT failure or reintubation within 48 hours. Data will be retrieved from electronic medical records.
Time frame: Collected from study inclusion until Day 28, or ICU/hospital discharge or death, whichever occurs first
ICU length of stay
Data about ICU length of stay will be retrieved from electronic medical records.
Time frame: Collected from study inclusion until Day 28, or ICU discharge or death, whichever occurs first
Hospital length of stay
Data about hospital length of stay will be retrieved from electronic medical records.
Time frame: Collected from study inclusion until Day 28, or hospital discharge or death, whichever occurs first
ICU mortality
Data about ICU mortality will be retrieved from electronic medical records.
Time frame: Collected from study inclusion until Day 28, or ICU discharge or death, whichever occurs first
Hospital mortality
Data about hospital mortality will be retrieved from electronic medical records.
Time frame: Collected from study inclusion until Day 28, or hospital discharge or death, whichever occurs first
Day 28 all-cause mortality
Data about day 28 all-cause mortality will be retrieved from electronic medical records.
Time frame: Collected from study inclusion until Day 28 or death, whichever occurs first
ICU-free days through day 28
Data about ICU-free days through day 28 will be retrieved from electronic medical records.
Time frame: Collected from ICU discharge until Day 28 or death, whichever occurs first
Hospital-free days through day 28
Data about hospital-free days through day 28 will be retrieved from electronic medical records.
Time frame: Collected from hospital discharge until Day 28 or death, whichever occurs first
Time to ICU discharge alive through day 28
Data about time to ICU discharge alive through day 28 will be retrieved from electronic medical records.
Time frame: Collected from study inclusion until Day 28, or ICU discharge or death, whichever occurs first
Time to hospital discharge alive through day 28
Data about time to hospital discharge alive through day 28 will be retrieved from electronic medical records.
Time frame: Collected from study inclusion until Day 28, or hospital discharge or death, whichever occurs first
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Sep 2028, 23 months later.
Of 232 non-industry observational studies under Respiratory Insufficiency, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 54. This study's planned 23 months is close to that.
Counting every sponsor, half of 248 studies reached it within 22 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Radboud University Medical Center →