Conventional vs Neurally Adjusted Ventilatory Assist in Difficult Weaning From Mechanical Ventila… (NCT02382861) | Clinical Trial Compass
CompletedNot Applicable
Conventional vs Neurally Adjusted Ventilatory Assist in Difficult Weaning From Mechanical Ventilation
France47 participantsStarted 2015-02-20
Plain-language summary
The NAVA, by its more physiological aspect and a better adaptation of the patient to the ventilator with a decrease of asynchronies patients-ventilators, could decrease the duration of weaning and so decrease the duration of invasive mechanical ventilation and the morbi-mortality. The objective of this study is to compare the neurally adjusted ventilatory assist versus the usual management of weaning from mechanical ventilation, in term of duration of weaning, at the patients in period of difficult weaning from the invasive mechanical ventilation.
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:
* Age \>18 years
* Under mechanical ventilation \> 48 hours
* A first failure of a SBT
* Plateau pressure 30cmH2O with tidal volume 8ml / kg
* SpO2 ≥ in 90 % with a FiO2 ≥ 50 %, or PaO2 / FiO2 \> 150mmHg
* Positive expiratory pressure 8cmH2O
* No more of one mg/hour of noradrenaline or adrenalin
* Temperature \>36 and \<39°C.
* Stable neurological state (Glasgow scale \> 4) without sedation (or very low sedation).
* Consent, dated and signed by the patient or his representative.
Exclusion Criteria:
* Contraindications to the NAVA (recent high digestive suture or oesophageal varices bleeding \< 4 days).
* Pregnant woman.
* Age \<18 years.
* Tracheotomy.
* Cardiac arrest with a reserved neurological prognostic.
* Therapeutic limitation.
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
Duration of weaning from the mechanical invasive ventilation.