Tracheostomy DecannulationNCT04835272
Comparison of the Decannulation Protocol With Suctioning and Capping in Severe Acquired Brain Injury Patients
A study testing the Decannulation Protocol With Suctioning in people with Tracheostomy Decannulation and Acquired Brain Injury, run by Fu Xing Hospital, Capital Medical University at 1 site in China.
Trial summary
Single-center randomized trail focused on tracheostomized patients with severe acquired brain injury , comparing two different decannulation protocols: 1. an assessment of readiness for decannulation that was based on suctioning frequency 2. an assessment that was based on tracheostomy capping Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy Decannulation, Acquired Brain Injury
- What is being tested?
- the Decannulation Protocol With Suctioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 30 Oct 2023
- Phase
- Interventional
- 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
Who may be able to join
- Within three months of onset
- Age≥18 years old
- GCS≥8
- Clinical stability( defined as the absence of fever, sepsis, or active infection and hemodynamic stability)
- Without massive pooling or silent aspiration of saliva, more than one efficient swallow per minute, adequate cough reflex were tested by gently touching the aryepiglottic region with the tip of the endoscope.
- Passing a tracheostomy-tube de-cuff test(de-cuff the tube for 3 days without pulmonary complications.
- Without significant airway stenosis.
Who cannot join
- Patients with pending diagnostic or therapeutic procedures and were considered by the clinicians to be at risk for neurologic deterioration
- Medical history of severe respiratory system or heart disease
- Neuromuscular disease other than ICU-acquired weakness, or tracheostomy for airway control
- Don't get informed consent from patient or guardian
Trial locations and contacts
1 site in 1 country.
China1 site
Fuxing hospital, capital medical university
Beijing
Yong Wang, 010-88062907, wyrehabil@ccmu.edu.cn
About this study
Official title: Tracheostomy Decannulation in Severe Acquired Brain Injury: a Decannulation Protocol With Suctioning or Capping?
Single-center randomized trail focused on tracheostomized patients with severe acquired brain injury , comparing two different decannulation protocols:
- an assessment of readiness for decannulation that was based on suctioning frequency
- an assessment that was based on tracheostomy capping
- Conditions
- Tracheostomy Decannulation, Acquired Brain Injury
- Being tested
- the Decannulation Protocol With Suctioning
- Keywords
- Tracheostomy, Decannulation, without capping, Airway patency assessment
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Decannulation Protocol With SuctioningProcedure or surgery
Also called the Decannulation Protocol With Capping
In the intervention group, the decision to decannulate was based on suctioning frequency. Patients underwent decannulation when they had had no more than two aspirations every 8 hours during during a 24-hour period. Patients in this group did not undergo capping trials.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | In the control group, the decision to decannulate was based on a 48-hour capping trial. |
| intervention group | Experimental | In the intervention group, the decision to decannulate was based on suctioning frequency. Receives: Procedure: the Decannulation Protocol With Suctioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time to decannulation
the time from randomization to actual decannulation
Measured: From the date of randomization to decannulation, and the patients will be followed for the duration of hospital stay, an expected average of 3 months
Secondary outcomes (5)
Rate of decannulation failure
reintubation within 1 week after decannulation
Measured: within 1 week after decannulation
high dependency unit length of stay
the time from high dependency unit admission to rehabilitation ward
Measured: From the date of high dependency unit admission to transferring to rehabilitation ward, and the patients will be followed for the duration of high dependency unit stay, an expected average of 2 months
Rate of respiratory infections
post decannulation respiratory infections rate in each study group
Measured: From the date of high dependency unit admission to hospital discharge, and the patients will be followed for the duration of hospital stay, an expected average of 3 months
Glasgow Outcome Scale(GOS) six months after the acute brain injury
The GOS is a brief descriptive outcome scale(from 0 point to 29 points, higher score means worse outcome). GOS six months after discharge to asess the prognosis of the patient
Measured: follow-up six months after discharge
Functional Independence Measure(FIM) six months after the acute brain injury
The FIM is an 18-item ordinal scale, is viewed as most useful for assessment of progress during inpatient rehabilitation（from 18 points to 126 points, higher score means better outcome）.
Measured: follow up six months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Nov 2021 (estimated)
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheostomy DecannulationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Xing Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Lu, Fu Xing Hospital, Capital Medical University
- Investigators
- Yong Wang, Study chair, Rehabilitation medicine center, Fuxing hospital, capital medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835272
- Sponsor's protocol ID
- songlu20210320
- Status last verified
- Oct 2021
- First submitted
- 29 Mar 2021
- Last updated
- 18 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication are to be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheostomy Decannulation in Severe Acquired Brain Injury: a Decannulation Protocol With Suctioning or Capping?
- ClinicalTrials.gov ID
- NCT04835272
- Acronym / sponsor ID
- songlu20210320
- Conditions
- Tracheostomy Decannulation, Acquired Brain Injury
- Keywords
- Tracheostomy, Decannulation, without capping, Airway patency assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Fu Xing Hospital, Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 8 Apr 2021 (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.
Single-center randomized trail focused on tracheostomized patients with severe acquired brain injury , comparing two different decannulation protocols:
- an assessment of readiness for decannulation that was based on suctioning frequency
- an assessment that was based on tracheostomy capping
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –In the control group, the decision to decannulate was based on a 48-hour capping trial. |
| intervention group | Experimental | Procedure: the Decannulation Protocol With SuctioningIn the intervention group, the decision to decannulate was based on suctioning frequency. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Within three months of onset
- Age≥18 years old
- GCS≥8
- Clinical stability( defined as the absence of fever, sepsis, or active infection and hemodynamic stability)
- Without massive pooling or silent aspiration of saliva, more than one efficient swallow per minute, adequate cough reflex were tested by gently touching the aryepiglottic region with the tip of the endoscope.
Key exclusion criteria (4 listed)
- Patients with pending diagnostic or therapeutic procedures and were considered by the clinicians to be at risk for neurologic deterioration
- Medical history of severe respiratory system or heart disease
- Neuromuscular disease other than ICU-acquired weakness, or tracheostomy for airway control
- Don't get informed consent from patient or guardian
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 |
|---|---|---|
| the Decannulation Protocol With SuctioningAlso: the Decannulation Protocol With CappingIn the intervention group, the decision to decannulate was based on suctioning frequency. Patients underwent decannulation when they had had no more than two aspirations every 8 hours during during a 24-hour period. Patients in this group did not undergo capping trials. | Procedure or surgery | intervention group |
Primary outcome
the time to decannulation
Time frame: From the date of randomization to decannulation, and the patients will be followed for the duration of hospital stay, an expected average of 3 months
the time from randomization to actual decannulation
5 secondary outcomes
Rate of decannulation failure
Time frame: within 1 week after decannulation
high dependency unit length of stay
Time frame: From the date of high dependency unit admission to transferring to rehabilitation ward, and the patients will be followed for the duration of high dependency unit stay, an expected average of 2 months
Rate of respiratory infections
Time frame: From the date of high dependency unit admission to hospital discharge, and the patients will be followed for the duration of hospital stay, an expected average of 3 months
Glasgow Outcome Scale(GOS) six months after the acute brain injury
Time frame: follow-up six months after discharge
Functional Independence Measure(FIM) six months after the acute brain injury
Time frame: follow up six months after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication are to be shared
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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.
Yong Wang study chair
Rehabilitation medicine center, Fuxing hospital, capital medical university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the Decannulation Protocol With Suctioning in people with Tracheostomy Decannulation and Acquired Brain Injury, run by Fu Xing Hospital, Capital Medical University at 1 site in China.
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 7 inclusion and 4 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 18 Oct 2021. 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 China. 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?
Contact Lu Song (+86 15010852973, songlu@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time to decannulation (time frame: From the date of randomization to decannulation, and the patients will be followed for the duration of hospital stay, an expected average of 3 months). 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 18 Oct 2021; AzTrials last refreshed its copy on 31 Oct 2026.