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

Not Applicable

• Conditions: Tracheostomy Decannulation; Acquired Brain Injury
• Interventions: Procedure: the Decannulation Protocol With Suctioning

• Registration Number: NCT04835272
• Lead Sponsor: Fu Xing Hospital, Capital Medical University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-04-04
• Study First Posted: 2021-04-08
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-09
• Last Update Posted: 2021-10-18
• Study Start: 2021-11-01
• Primary Completion: 2023-03-30
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	the Decannulation Protocol With Suctioning	In the intervention group, the decision to decannulate was based on suctioning frequency.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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）.

Trial Locations

Locations (1)

Fuxing hospital, capital medical university; 🇨🇳 Beijing, China