Clinical Outcome Following Early Decannulation of Severe Acquired Brain Injury Patients

Brain Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06167538
• Other study ID #: p-2023-14366
• Status: Active, not recruiting
• Start date: July 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: December 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All severe acquired brain injury patients = 18 years with a tracheal tube at admission. Exclusion Criteria: -

Related Conditions & MeSH terms

• Brain Injuries
• Wounds and Injuries

Intervention

Other:
• Decannulation
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.

Locations

Country	Name	City	State
Denmark	Department of Brain Injury, Rigshospitalet	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality at three months after hospital discharge	Rate of survival	Three months counted from hospital discharge
Primary	Mortality at twelve months after hospital discharge	Rate of survival	Twelve months counted from hospital discharge
Secondary	Rate of antibiotics prescribed to treat pneumonia after decannulation	Pneumonia as assessed by treating physician	Counted number of days from decannulation until discharge
Secondary	Rate of re-cannulation of the tracheal tube after initial decannulation	Assessment of failed decannulation attempts	Counted number of days from decannulation until discharge
Secondary	Length of hospital stay	LOS counted from admission to our department	Counted number of days from admission to our department until discharge
Secondary	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