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Clinical Outcome Following Early Decannulation of Severe Acquired Brain Injury Patients

NCT ID: NCT06167538

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-04-01

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.

Detailed Description

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Conditions

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Brain Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Decannulation

Intervention Type 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.

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.

Decannulation

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Robbert-Jan van Hooff

Clinical Head, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Brain Injury, Rigshospitalet

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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p-2023-14366

Identifier Type: -

Identifier Source: org_study_id