Clinical Outcome Following Early Decannulation of Severe Acquired Brain Injury Patients

Study Overview
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Brief Summary
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After severe acquired brain injury (SABI: severe traumatic brain injury, stroke, anoxic brain damage), up to 50-70% of patients are tracheostomized. The need to tracheostomize a patient is based on the prolonged inability to breathe and/or protect their airway sufficiently. This is usually done in an Intensive Care Unit (ICU). A tracheostomy is first removed when the patient's clinical conditions allow for it. The removal can be performed in many settings, a neurological rehabilitation unit being one of these. The overall objective of this study is to evaluate the safety of this earlier decannulation procedure in patients with SABI at our department as well as the effectiveness on functional ability.

Official Title
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Clinical Outcome Following Early Decannulation of Severe Acquired Brain Injury Patients: a Retrospective Cohort Study

Conditions
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Brain Injuries

Intervention / Treatment
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* Other: Decannulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All severe acquired brain injury patients ≥ 18 years with a tracheal tube at admission. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SABI patients with a tracheal tube treated with the new decannulation procedure.<br>All adult SABI patients ≥ 18 years with a tracheal tube at admission to the Department of Brain Injury from September 2021 to October 2022 and treated with the new decannulation procedure. | Other: Decannulation<br>* From the 1st of September 2021, the investigators started to perform decannulation earlier after admission to the Department of Brain Injury. Before attempting to decannulate a patient, several factors were considered and assessed by the patient's treating team: patient's level of consciousness, hemodynamical stability, need for and frequency of salivary aspiration, cough strength and respiration frequency. Patients could not be under treatment for pneumonia and simultaneously have respiratory instability at the time of decannulation.<br>|
| SABI patients in whom decannulation was attempted before implementation of the new procedure.<br>Patients with SABI and a tracheal tube in whom decannulation was attempted between July 2019 until December 2020 will serve as a historical control group. | Other: Decannulation<br>* From the 1st of September 2021, the investigators started to perform decannulation earlier after admission to the Department of Brain Injury. Before attempting to decannulate a patient, several factors were considered and assessed by the patient's treating team: patient's level of consciousness, hemodynamical stability, need for and frequency of salivary aspiration, cough strength and respiration frequency. Patients could not be under treatment for pneumonia and simultaneously have respiratory instability at the time of decannulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at three months after hospital discharge | Rate of survival | Three months counted from hospital discharge | 
| Mortality at twelve months after hospital discharge | Rate of survival | Twelve months counted from hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of antibiotics prescribed to treat pneumonia after decannulation | Pneumonia as assessed by treating physician | Counted number of days from decannulation until discharge | 
| Rate of re-cannulation of the tracheal tube after initial decannulation | Assessment of failed decannulation attempts | Counted number of days from decannulation until discharge | 
| Length of hospital stay | LOS counted from admission to our department | Counted number of days from admission to our department until discharge | 
| Rate of hospital readmission at two and twelve months after discharge | Rate of hospital readmission, and if yes, for what cause | At two and twelve months respectively counted from discharge |