Comparison of Two Ventilator Mode During the Night: New Strategy of Mechanical Ventilation Weaning (NCT01573481) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Two Ventilator Mode During the Night: New Strategy of Mechanical Ventilation Weaning
France19 participantsStarted 2012-01
Plain-language summary
The purpose of the study is to compare pressure controlled continuous mandatory ventilation versus pressure support ventilation during the night for weaning to mechanical ventilation in chronic obstructive pulmonary disease patients and their impact onto sleep quality.
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 and/or legal representative of the patient has provided a written informed consent before inclusion in the study
* The patients is hospitalized in respiratory and critical care unit (university hospital of AMIENS, FRANCE)
* the patient is mechanically ventilated (ventilator model : puritan-bennett B840)
* Pulmonary disease,chronic obstructive (Spirometry and Blood Gas Analysis in chronic state before admission)
* stable cardiovascular status (cardiac frequency \< 140 beats/min and systolic blood pressure : 90-160 mmHg without catecholamines)
* midazolam \< 0,05mg/kg/h
* sufentanyl \< 0,05µ/kg/h
* the disorder that caused respiratory failure and prompted mechanical ventilation is treated
* the clinician suspects the patient may be ready to begin the weaning process
* inspiratory oxygen fraction (FiO2) \< 50%
* positive end-expiratory pressure \< or equal 8cmH2O
* during the day, the patient tolerate pressure support ventilation (pressure support level \< 15cmH2O
* respiratory frequency (FR) \< 35 breaths/min
* tidal volume (VT) \> 5ml/kg
* PaO2/FiO2 \> 200 mmHg
* FR/VT \< 105 breaths/min/L
Exclusion Criteria:
* sleep apnea, central
* narcolepsy
* Encephalopathy, Metabolic AND Encephalitis
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
Weaning duration
Timeframe: between one to 21 days (the study will begin when patient presents weaning criteria and will stop 48 days after extubation.)