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Clinical Outcome Following Early Decannulation of Severe Acquired Brain Injury Patients

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06167538
Enrollment
60
Registered
2023-12-12
Start date
2023-07-01
Completion date
2024-04-01
Last updated
2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries

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.

Interventions

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.

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Mortality at three months after hospital dischargeThree months counted from hospital dischargeRate of survival
Mortality at twelve months after hospital dischargeTwelve months counted from hospital dischargeRate of survival

Secondary

MeasureTime frameDescription
Rate of antibiotics prescribed to treat pneumonia after decannulationCounted number of days from decannulation until dischargePneumonia as assessed by treating physician
Rate of re-cannulation of the tracheal tube after initial decannulationCounted number of days from decannulation until dischargeAssessment of failed decannulation attempts
Length of hospital stayCounted number of days from admission to our department until dischargeLOS counted from admission to our department
Rate of hospital readmission at two and twelve months after dischargeAt two and twelve months respectively counted from dischargeRate of hospital readmission, and if yes, for what cause

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026