An interventional study of Repetition of medical examinations performed as part of the care in Ventilator Weaning, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-02.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic
Among 22 studies in Pulmonary Edema with a site in France — 6 open to participants now, 6 under way, none of them phase 3. Pulmonary Edema · France.
Among the 22 studies in Pulmonary Edema with a site in France, this one is the 10th largest by enrollment of the 12 interventional ones that give a count, is one of 2 that started in 2018, is one of 10 with no phase, and was the 9th registered.
126 studies on the registry are indexed under Pulmonary Edema; 27 are open to participants now.
Browse Pulmonary Edema studies →6 of the 22 studies in Pulmonary Edema with a site in France are open now. Recruiting first, the newest first:
Centre Hospitalier Régional d'Orléans · Sites in France
Ages 18+
Centre Hospitalier Universitaire de la Réunion · Sites in France
Ages 18+
University Hospital, Strasbourg, France · Sites in France
Ages 76+
Direction Centrale du Service de Santé des Armées · Sites in France
Ages 18–60 · Healthy volunteers
Centre Hospitalier Universitaire de Nice · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 20 Pulmonary Edema studies recruiting now, 18 (90%) set no upper age limit and 1 (5%) stops at 75 or younger; 2 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2018.
This study's enrollment of 47 is below the median of 65 across 62 interventional studies indexed under Pulmonary Edema.
Median enrollment 79 across the 12 interventional studies, 100 across the 8 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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None of the 22 has an industry lead sponsor. The 10 most frequent:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,596 studies on the registry; 1,037 are open to participants now.
Assistance Publique - Hôpitaux de Paris has 4 studies filed under Pulmonary Edema — fewer than ten, so there is no comparison to draw.
1 of the studies in Pulmonary Edema with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06923267Centre Hospitalier Régional d'OrléansUltrasound Evaluation of Cardiac Function During Spontaneous Breathing Trials | 2027-04-09 |
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Among the 22 studies in Pulmonary Edema with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Weaning failure is associated with prolonged duration of mechanical ventilation that itself can worsen patient's prognosis. Therefore, identification of the causes and mechanisms leading to weaning failure is important in daily practice. While diaphragm dysfunction and pulmonary edema are two main causes of weaning failure, there are currently no data that quantify their respective contribution neither their potential co-existence. During weaning from mechanical ventilation, heart and lung interaction plays a major role. As a key factor, diaphragm function is therefore certainly involved in the occurrence of weaning-induced pulmonary edema. However, both phenomenons diaphragm dysfunction and weaning induced pulmonary edema have not been simultaneously investigated so far. This current project aims at exploring the relationship between diaphragm dysfunction and pulmonary in patients experiencing weaning failure. The objectives are 1) to quantify the respective contribution and co-existence of diaphragm dysfunction and weaning induced pulmonary edema and 2) to investigate the role of diaphragm function in the occurrence of weaning induced pulmonary edema.
The study will take place in the Medical ICU of Pitié-Salpêtrière Hospital in Paris. The ICU have an established and successful clinical research program and infrastructure.
ICU patients will be enrolled if eligible (based on inclusion and non inclusion criteria) after their first spontaneous breathing trial failure.
Diaphragm function will be assessed by its capacity to generate a pressure with the phrenic nerves stimulation technique (reference method) and by ultrasonography (thickening fraction). Weaning induced pulmonary edema will be diagnosed with cardiac echo and markers of plasma contraction (plasma protein concentration).
Phrenic nerves stimulation, diaphragm and cardiac ultrasound will be repeated as part of the research before the spontaneous breathing trial.
After obtaining consent and before starting the second spontaneous breathing trial, clinical and biological will be collected. EKG and maximal inspiratory pressure will be done. Then, a diaphragm ultrasound and cardiac echo will be done and the phrenic nerves stimulation method will be undertaken. After these measurements, the spontaneous breathing trial will start. At the end of the spontaneous breathing trial (30 minutes with pressure support 7 cmH2O and 0 positive end expiratory pressure) or sooner in case of intolerance (respiratory distress), a new cardiac echo and diaphragm ultrasound will be performed as part of standard care before resuming the initial ventilator settings. As recommended by the usual medical practice, a second phrenic nerves stimulation will be eventually done after resuming the initial ventilator settings.
Diaphragm capacity to generate pressure :
Twitch airway pressure (Ptr, stim) will be measured during phrenic nerve stimulation. Phrenic nerve stimulation will be performed by bilateral anterior magnetic stimulation.
Cardiac echo :
Cardiac echo will be performed with a Philips Sparq ultrasound with a dedicated probe. The following variables will be obtained: left ventricular ejection fraction, E wave, A wave, E' wave, TAPSE
Diaphragm ultrasound :
Diaphragm thickening fraction will be measured by placing 13 MHz transducer on the right chest wall in the ninth intercostal space mid-way between the anterior and mid-axillary line and held perpendicular to the chest wall. Thickening fraction will be computed as the percentage change in thickness between end-expiration (i.e. minimum muscle thickness) and peak inspiration (i.e. maximal muscle thickness) visualized in M-mode.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Repetition of medical examinations performed as part of the care. All patients will have a cardiac echo examination and diaphragm function assessment before the spontaneous breathing trial.
Other: Repetition of medical examinations performed as part of the care
Cardiac echo, diaphragm ultrasound and phrenic nerves stimulation performed before the spontaneous breathing trial.
Failure at the spontaneous breathing trial
Weaning failure defined by the criteria of the International Conference on Weaning (Boles et al. ERJ 2007)
Time frame: During or at the end of the spontaneous breathing trial
Rate of patients with diaphragm dysfunction
Diaphragm dysfunction will be defined as a decrease capacity of the diaphragm to generate a pressure
Time frame: At the end of the patient participation (Day 3)
Rate of patients with weaning induced pulmonary edema
Weaning induced pulmonary edema will be defined by an increase in left filling pressure and/or plasma protides concentration
Time frame: At the end of the patient participation (Day 3)
Rate of patients with diaphragm dysfunction and weaning induced pulmonary edema
Diaphragm dysfunction will be defined as a decrease capacity of the diaphragm to generate a pressure and weaning induced pulmonary edema will be defined by an increase in left filling pressure and/or plasma protides concentration
Time frame: At the end of the patient participation (Day 3)
Ran from Apr 2018 to primary completion in Apr 2018, 0 months.
Of 22 interventional studies with no phase under Pulmonary Edema, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 69. This study's 0 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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