Effect of Three Modalities of Spontaneous Breathing Tests on Respiratory Efforts in Tracheostomiz… (NCT03856424) | Clinical Trial Compass
UnknownNot Applicable
Effect of Three Modalities of Spontaneous Breathing Tests on Respiratory Efforts in Tracheostomized Patients
Switzerland18 participantsStarted 2019-03-08
Plain-language summary
Datas are lacking concerning weaning from mechanical ventilation for tracheostomized patients. In particular, the effect of different modalities of spontaneous breathing trials on respiratory effort has not been extensively described.
This crossover physiology study will include 18 tracheostomized patients ventilated for more than 72 hours.
The objective of this study is to compare the effect of three different modalities of SBTs on respiratory effort in tracheostomized patients. The modalities tested are : Pressure Support Ventilation (PSV level 5 cmH2O, PEEP 5 cmH2O), T-piece test and high-flow Oxygen. Each modality is applied in a randomized order, during 30 minutes. During every modality tested, esophageal and gastric pressure, expired CO2, and comfort will be monitored, in addition to standard monitoring. Based on esophageal pressure monitoring, patient's respiratory efforts can be calculated either by esophageal pressure-time product and work of breathing. Pressure generated by inspiratory muscles will also be assessed.
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:
* Patients for whom a tracheostomy is planned
* Patients on invasive ventilation for \>72 hours
Exclusion Criteria:
* Tracheostomy for upper airway obstruction or other disease
* Patients tracheostomized before current hospitalization
* Patients with Glasgow Coma Scale (GCS) \< 8/10 after cardiac arrest
* Patients with GCS \< 8/10 because of primary central neurologic disease
* Patients for whom therapeutic limitations have already been decided
* Patients for whom weaning from ventilation is not an objective
* Patients suffering from myasthenia gravis
* Patients with cardiac assistance device
* Patients with medullary lesion proximal to C5
* Patients for whom nasogastric tube insertion is contraindicated
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
Evolution of pressure-time product of esophageal pressure
Timeframe: Recorded every 5 minutes during each sequence and washout period, 180 minutes