Clinical Outcome Following Early Decannulation of Severe Acquired Brain Injury Patients

NCT06167538 | Unknown

• 1 other identifier: p-2023-14366
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Rate of antibiotics prescribed to treat pneumonia after decannulation

  Counted number of days from decannulation until discharge

• Rate of re-cannulation of the tracheal tube after initial decannulation

  Counted number of days from decannulation until discharge

• Length of hospital stay

  Counted number of days from admission to our department until discharge

• Rate of hospital readmission at two and twelve months after discharge

  At two and twelve months respectively counted from discharge

Study Arms (2)

SABI patients with a tracheal tube treated with the new decannulation procedure.

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

SABI patients in whom decannulation was attempted before implementation of the new procedure.

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

Interventions

Decannulation OTHER

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.

SABI patients in whom decannulation was attempted before implementation of the new procedure.; SABI patients with a tracheal tube treated with the new decannulation procedure.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 will be included. 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.

You may qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Brain Injury, Rigshospitalet

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

Tracheostomy Decannulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Tracheostomy; Airway Management; Therapeutics; Device Removal; Surgical Procedures, Operative; Ostomy; Otorhinolaryngologic Surgical Procedures; Thoracic Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Head, MD, PhD

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: December 12, 2023
• Study Start: July 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: April 1, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

DK (1)