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

Fu Xing Hospital, Capital Medical University104 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

104

Conditions

Tracheostomy Decannulation Acquired Brain Injury

Interventions

the Decannulation Protocol With SuctioningPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Fuxing hospital, capital medical university

Beijing, China

Outcomes

Primary Outcomes

the time to decannulation

the time from randomization to actual 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

Secondary Outcomes

Rate of decannulation failure

reintubation within 1 week after decannulation

Time frame: within 1 week after decannulation

high dependency unit length of stay

the time from high dependency unit admission to rehabilitation ward

Time frame: 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

post decannulation respiratory infections rate in each study group

Time frame: 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

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

Time frame: follow-up six months after discharge

Functional Independence Measure(FIM) six months after the acute brain injury

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）.

Central Contacts

Lu Song

CONTACT

+86 15010852973 songlu@ccmu.edu.cn

Data from ClinicalTrials.gov

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