Clinical Outcome Following Early Decannulation of Severe Acquired Brain Injury Patients

Active, not recruiting

• Conditions: Brain Injuries
• Interventions: Other: Decannulation

• Registration Number: NCT06167538
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2023-11-17
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-11
• Last Update Submitted: 2023-12-11
• Study First Posted: 2023-12-12
• Last Update Posted: 2023-12-12
• Primary Completion: 2024-01-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

All severe acquired brain injury patients ≥ 18 years with a tracheal tube at admission.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SABI patients with a tracheal tube treated with the new decannulation procedure.	Decannulation	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.
SABI patients in whom decannulation was attempted before implementation of the new procedure.	Decannulation	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.

Primary Outcome Measures

Name	Time	Method
Mortality at three months after hospital discharge	Three months counted from hospital discharge	Rate of survival
Mortality at twelve months after hospital discharge	Twelve months counted from hospital discharge	Rate of survival

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Brain Injury, Rigshospitalet; 🇩🇰 Glostrup, Denmark