Comparison of the Decannulation Protocol With Suctioning and Capping in Severe Acquired Brain Injury Patients

Study Overview
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Brief Summary
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Single-center randomized trail focused on tracheostomized patients with severe acquired brain injury , comparing two different decannulation protocols: an assessment of readiness for decannulation that was based on suctioning frequency an assessment that was based on tracheostomy capping

Official Title
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Tracheostomy Decannulation in Severe Acquired Brain Injury: a Decannulation Protocol With Suctioning or Capping?

Conditions
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Tracheostomy Decannulation, Acquired Brain Injury

Intervention / Treatment
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* Procedure: the Decannulation Protocol With Suctioning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>In the control group, the decision to decannulate was based on a 48-hour capping trial. | |
| Experimental: intervention group<br>In the intervention group, the decision to decannulate was based on suctioning frequency. | Procedure: the Decannulation Protocol With Suctioning<br>* In the intervention group, the decision to decannulate was based on suctioning frequency. Patients underwent decannulation when they had had no more than two aspirations every 8 hours during during a 24-hour period. Patients in this group did not undergo capping trials.<br>* Other names: the Decannulation Protocol With Capping;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time to decannulation | the time from randomization to actual decannulation | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of decannulation failure | reintubation within 1 week after decannulation | within 1 week after decannulation | 
| high dependency unit length of stay | the time from high dependency unit admission to rehabilitation ward | From the date of high dependency unit admission to transferring to rehabilitation ward, and the patients will be followed for the duration of high dependency unit stay, an expected average of 2 months | 
| Rate of respiratory infections | post decannulation respiratory infections rate in each study group | From the date of high dependency unit admission to hospital discharge, and the patients will be followed for the duration of hospital stay, an expected average of 3 months | 
| Glasgow Outcome Scale(GOS) six months after the acute brain injury | The GOS is a brief descriptive outcome scale(from 0 point to 29 points, higher score means worse outcome). GOS six months after discharge to asess the prognosis of the patient | follow-up six months after discharge | 
| Functional Independence Measure(FIM) six months after the acute brain injury | The FIM is an 18-item ordinal scale, is viewed as most useful for assessment of progress during inpatient rehabilitation（from 18 points to 126 points, higher score means better outcome）. | follow up six months after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tracheostomy, Decannulation, without capping, Airway patency assessment