TerminatedNot Applicable

Comparative Effects on Diaphragmatic Electrical Activity and Respiratory Pattern of Various Levels of Assistance

Stopped: Difficulties to enroll patients

Switzerland2 participantsStarted 2010-08

Plain-language summary

Exploration of the effects on diaphragmatic electrical activity (EMG) and on respiratory pattern of various level of assistance delivered by the ventilator in intubated spontaneously breathing patients in pressure support (PS) and in Neurally Adjusted Ventilatory Assist (NAVA) by step by step increasing of the level of assistance. Flow, airway pressure, transesophageal EMG signal and transcutaneous EMG signal will be recorded.

Who can participate

Age range

18 Years – 90 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: \- Patients admitted to the ICU, intubated for acute respiratory failure, and ventilated in PS mode will be eligible for inclusion in the study. Exclusion Criteria: * Severe hypoxemia requiring an FIO2 \> 0.5 * hemodynamic instability (defined as the need for high doses of catecholamines namely ≥ 0.5 μg/kg min- and/or high need in volume resuscitation namely more than two litres of crystalloids in two hours-) * oesophageal problem such as hiatal hernia, oesophageal varicosities, oesophageal surgery; * active upper gastro-intestinal bleeding; * known coagulation disorder; * any other contraindication to the insertion of a naso-gastric tube; * poor short term prognosis (death expected within the next seven days) * age \< 18 years old.

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

Electrical diaphragmatic signal variations and ventilatory profile variations under various level of assistance

Trial details

NCT IDNCT01248845

SponsorProf. Philippe Jolliet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-06

View on ClinicalTrials.gov More Respiratory Failure trials