Brain InjuriesNCT06167538
Clinical Outcome Following Early Decannulation of Severe Acquired Brain Injury Patients
An observational study of Brain Injuries, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Decannulation
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2023to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All severe acquired brain injury patients ≥ 18 years with a tracheal tube at admission.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Brain Injury, Rigshospitalet
Glostrup Municipality, 2600
About this study
Official title: Clinical Outcome Following Early Decannulation of Severe Acquired Brain Injury Patients: a Retrospective Cohort Study
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
- Being tested
- Decannulation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecannulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Decannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at three months after hospital discharge
Rate of survival
Measured: Three months counted from hospital discharge
Mortality at twelve months after hospital discharge
Rate of survival
Measured: Twelve months counted from hospital discharge
Secondary outcomes (4)
Rate of antibiotics prescribed to treat pneumonia after decannulation
Pneumonia as assessed by treating physician
Measured: Counted number of days from decannulation until discharge
Rate of re-cannulation of the tracheal tube after initial decannulation
Assessment of failed decannulation attempts
Measured: Counted number of days from decannulation until discharge
Length of hospital stay
LOS counted from admission to our department
Measured: Counted number of days from admission to our department until discharge
Rate of hospital readmission at two and twelve months after discharge
Rate of hospital readmission, and if yes, for what cause
Measured: At two and twelve months respectively counted from discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Jul 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robbert-Jan van Hooff, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167538
- Sponsor's protocol ID
- p-2023-14366
- Status last verified
- Dec 2023
- First submitted
- 17 Nov 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome Following Early Decannulation of Severe Acquired Brain Injury Patients: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06167538
- Acronym / sponsor ID
- p-2023-14366
- Conditions
- Brain Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SABI patients with a tracheal tube treated with the new decannulation procedure. | – | Other: DecannulationAll 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. | – | Other: DecannulationPatients with SABI and a tracheal tube in whom decannulation was attempted between July 2019 until December 2020 will serve as a historical control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All severe acquired brain injury patients ≥ 18 years with a tracheal tube at admission.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DecannulationFrom 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. | Other | 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. |
Primary outcome
Mortality at three months after hospital discharge
Time frame: Three months counted from hospital discharge
Rate of survival
Mortality at twelve months after hospital discharge
Time frame: Twelve months counted from hospital discharge
Rate of survival
4 secondary outcomes
Rate of antibiotics prescribed to treat pneumonia after decannulation
Time frame: Counted number of days from decannulation until discharge
Rate of re-cannulation of the tracheal tube after initial decannulation
Time frame: Counted number of days from decannulation until discharge
Length of hospital stay
Time frame: Counted number of days from admission to our department until discharge
Rate of hospital readmission at two and twelve months after discharge
Time frame: At two and twelve months respectively counted from discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at three months after hospital discharge (time frame: Three months counted from hospital discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.