Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT04835272
NCT04835272UnknownNot Applicable

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

Fu Xing Hospital, Capital Medical University1 site in 1 country104 target enrollmentStarted: November 1, 2021Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
104
Locations
1
Primary Endpoint
the time to decannulation
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Within three months of onset
  • •Age≥18 years old
  • •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

Arms & Interventions

control group

No Intervention

In the control group, the decision to decannulate was based on a 48-hour capping trial.

intervention group

Experimental

In the intervention group, the decision to decannulate was based on suctioning frequency.

Intervention: the Decannulation Protocol With Suctioning (Procedure)

Outcomes

Primary Outcomes

the time to decannulation

Time Frame: 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 Outcomes

  • Rate of decannulation failure(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)
  • 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)
  • Glasgow Outcome Scale(GOS) six months after the acute brain injury(follow-up six months after discharge)
  • Functional Independence Measure(FIM) six months after the acute brain injury(follow up six months after discharge)

Investigators

Sponsor
Fu Xing Hospital, Capital Medical University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Song Lu

Attending doctor

Fu Xing Hospital, Capital Medical University

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Efficacy and Safety of the DYNAtraq Device to Prevent Complications in Tracheostomy in Mechanically Ventilated PatientsTracheostomyMechanical Ventilation Complication
NCT04668742Fundación Cardiovascular de Colombia74
Active, not recruiting
Not Applicable
Clinical Outcome Following Early Decannulation of Severe Acquired Brain Injury PatientsBrain Injuries
NCT06167538Rigshospitalet, Denmark60
Completed
Not Applicable
Early Tracheostomy in Ventilated Stroke Patients 2Ischemic and Hemorrhagic Stroke, Subarachnoid Hemorrhage
NCT02377167University Hospital Heidelberg380
Completed
Not Applicable
Selective Bronchial Intubation (SBI)Selective Bronchial Tube
NCT03204656Centre Chirurgical Marie Lannelongue200
Completed
Not Applicable
Early Tracheostomy in Ventilated Stroke PatientsIschemic StrokeIntracerebral HemorrhageSubarachnoid Hemorrhage
NCT01261091Heidelberg University60