Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Eme… (NCT02273687) | Clinical Trial Compass
CompletedNot Applicable
Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department
France104 participantsStarted 2014-10-29
Plain-language summary
The main objective of this study is to show that "diaphragmatic excursion measures upon emergency admission" (CDA values) on patients with acute respiratory failure are predictive of the need to use mechanical ventilation (invasive or non-) in the first four hours.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The patient has given informed consent (and signed the consent form) or, in case of an emergency situation, an investigator has committed to obtaining the consent of the patient as soon as his/her condition permits
* Patient affiliated with or beneficiary of a health insurance plan
* Acute Respiratory Distress (DRA) defined by: (1) respiratory rate \> 25 and/or signs of struggle and hypoxia AND (2) SpO2 values \< 90% and/or \[pH \< 7.35 and pCO2 \> 6 kPa (45 mm Hg)\]
* Breathing spontaneously (no ventilation)
Exclusion Criteria:
* Patient currently participating in or having participated in another interventional study in the previous three months, or patient in an exclusion period determined by a previous study
* Patient under judicial protection or any kind of guardianship
* Refusal to sign the consent
* Patient pregnant, parturient, or lactating
* Neurological or neuromuscular disease modifying the operation of the diaphragm without any decompensation (Polyneuropathy, Lou Gehrig's disease, Myasthenia ...)
* Patient who received mechanical ventilation at home
* Patient who received treatment by mechanical ventilation during the pre-hospitalization care phase
* Patient admitted with respiratory failure requiring immediate installation of a mechanical ventilation and thus not allowing the performance of two ultrasound measurements
* Patient suffering from a pneumothorax
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measurement of diaphragmatic excursion by M-mode ultrasound