Clinical trial NCT04835272: Comparison of the Decannulation Protocol With Suctioning and Capping in Severe Acquired Brain Injury Patients
Official title: Tracheostomy Decannulation in Severe Acquired Brain Injury: a Decannulation Protocol With Suctioning or Capping?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tracheostomy Decannulation
Acquired Brain Injury
Keywords: Tracheostomy
Decannulation
without capping
Airway patency assessment
Lead sponsor: Fu Xing Hospital, Capital Medical University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Rate of decannulation failure
timeFrame: within 1 week after decannulation
measure: high dependency unit length of stay
timeFrame: 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
measure: Rate of respiratory infections
timeFrame: 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
measure: Glasgow Outcome Scale(GOS) six months after the acute brain injury
timeFrame: follow-up six months after discharge
measure: Functional Independence Measure(FIM) six months after the acute brain injury
timeFrame: follow up six months after discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuxing hospital, capital medical university
Study officials:
affiliation: Rehabilitation medicine center, Fuxing hospital, capital medical university
name: Yong Wang
role: STUDY_CHAIR
References: