Comparison of the Decannulation Protocol With Suctioning and Capping in Severe Acquired Brain Injury Patients
Study Details
Study Description
Brief Summary
Single-center randomized trail focused on tracheostomized patients with severe acquired brain injury , comparing two different decannulation protocols:
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an assessment of readiness for decannulation that was based on suctioning frequency
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an assessment that was based on tracheostomy capping
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: control group In the control group, the decision to decannulate was based on a 48-hour capping trial. |
|
| Experimental: intervention group In the intervention group, the decision to decannulate was based on suctioning frequency. |
Procedure: the Decannulation Protocol With Suctioning
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- the time to 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]
the time from randomization to actual decannulation
Secondary Outcome Measures
- Rate of decannulation failure [within 1 week after decannulation]
reintubation within 1 week after decannulation
- high dependency unit length of stay [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]
the time from high dependency unit admission to rehabilitation ward
- Rate of respiratory infections [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]
post decannulation respiratory infections rate in each study group
- Glasgow Outcome Scale(GOS) six months after the acute brain injury [follow-up six months after discharge]
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
- Functional Independence Measure(FIM) six months after the acute brain injury [follow up six months after discharge]
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）.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Within three months of onset
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Age≥18 years old
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GCS≥8
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Clinical stability( defined as the absence of fever, sepsis, or active infection and hemodynamic stability)
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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.
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Passing a tracheostomy-tube de-cuff test(de-cuff the tube for 3 days without pulmonary complications.
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Without significant airway stenosis.
Exclusion Criteria:
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Patients with pending diagnostic or therapeutic procedures and were considered by the clinicians to be at risk for neurologic deterioration
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Medical history of severe respiratory system or heart disease
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Neuromuscular disease other than ICU-acquired weakness, or tracheostomy for airway control
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Don't get informed consent from patient or guardian
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fuxing hospital, capital medical university | Beijing | China |
Sponsors and Collaborators
- Fu Xing Hospital, Capital Medical University
Investigators
- Study Chair: Yong Wang, Rehabilitation medicine center, Fuxing hospital, capital medical university
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- songlu20210320