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

F

Fu Xing Hospital, Capital Medical University

Status

Unknown

Conditions

Tracheostomy Decannulation
Acquired Brain Injury

Treatments

Procedure: the Decannulation Protocol With Suctioning

Study type

Interventional

Funder types

Other

Identifiers

NCT04835272
songlu20210320

Details and patient eligibility

About

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

Enrollment

104 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

104 participants in 2 patient groups

control group
No Intervention group
Description:
In the control group, the decision to decannulate was based on a 48-hour capping trial.
intervention group
Experimental group
Description:
In the intervention group, the decision to decannulate was based on suctioning frequency.
Treatment:
Procedure: the Decannulation Protocol With Suctioning

Trial contacts and locations

1

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Central trial contact

Lu Song

Data sourced from clinicaltrials.gov

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