Comparison of the Decannulation Protocol With Suctioning and Capping in Severe Acquired Brain Inj… (NCT04835272) | Clinical Trial Compass
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Comparison of the Decannulation Protocol With Suctioning and Capping in Severe Acquired Brain Injury Patients
China104 participantsStarted 2021-11-01
Plain-language summary
Single-center randomized trail focused on tracheostomized patients with severe acquired brain injury , comparing two different decannulation protocols:
1. an assessment of readiness for decannulation that was based on suctioning frequency
2. an assessment that was based on tracheostomy capping
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:
* Within three months of onset
* Age≥18 years old
* GCS≥8
* Clinical stability( defined as the absence of fever, sepsis, or active infection and hemodynamic stability)
* Without massive pooling or silent aspiration of saliva, more than one efficient swallow per minute, adequate cough reflex were tested by gently touching the aryepiglottic region with the tip of the endoscope.
* Passing a tracheostomy-tube de-cuff test(de-cuff the tube for 3 days without pulmonary complications.
* Without significant airway stenosis.
Exclusion Criteria:
* Patients with pending diagnostic or therapeutic procedures and were considered by the clinicians to be at risk for neurologic deterioration
* Medical history of severe respiratory system or heart disease
* Neuromuscular disease other than ICU-acquired weakness, or tracheostomy for airway control
* Don't get informed consent from patient or guardian
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
the time to decannulation
Timeframe: From the date of randomization to decannulation, and the patients will be followed for the duration of hospital stay, an expected average of 3 months
Trial details
NCT IDNCT04835272
SponsorFu Xing Hospital, Capital Medical University