DecanulationNCT07306091
Decanulation in Critically Ill Patients
An observational study of Decanulation, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
Purpose of the Study: To predict potential problems (such as shortness of breath and obstruction of the airway due to vocal cord immobility) before the tracheostomy cannula is removed, the patient's vocal cords, their movement, and airflow rate will be assessed at the bedside. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decanulation
- What is being tested?
- ultrasound guided airway examination
- Type of treatment
- Medical device
- How many people
- 107 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 1 Feb 2026
- How long will I take part?
- 15 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: critically ill patients whom suitable for decanulation after tracheostomy
Who may be able to join
- Critically ill patients (CIPs) who are receiving treatment within the specified time period and who require a tracheostomy.
- Critically ill patients who are suitable for decannulation (underwent spontaneous breathing trials with the use of CPAP ( CPAP level of maximum 6 cm of water and maximum 10 cm of water pressure support at least 24 hours ).
- Critically ill patients with intact swallowing reflexes ( patients were first examined for GAG reflexes, followed by ultrasonography; changes in muscle length and contraction velocity during swallowing were measured in a sagittal section using a convex probe ,
- CIPs with GCS>8.
Who cannot join
- 1.Critically ill patients under 18 years of age. 2.Critically ill patients who do not require tracheostomy. 3.Critically ill patients who are spontaneously breathing and can be weaned off the ventilator for <24 hours 4.Critically ill patients with GCS < 8. 5.Critically ill patients with absent swallowing reflexes
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Uludag Universty Faculty of MedicineDepartment of Anesthesiology and Reanimation, Bursa, Turkey
Bursa, 16140
About this study
Official title: Ultrasound-guided Decannulation With Critically Ill Patients; a Prospective Cohort Study
Purpose of the Study: To predict potential problems (such as shortness of breath and obstruction of the airway due to vocal cord immobility) before the tracheostomy cannula is removed, the patient's vocal cords, their movement, and airflow rate will be assessed at the bedside. The patient will also be examined using routine methods to identify these problems, and the results will be compared with ultrasound scans. The study aims to determine the success and failure of ultrasound in detecting these problems. Method and Procedures: While the patient is receiving treatment in the intensive care unit, the probe of the existing ultrasound device will be placed on the patient's neck, over the cannula, and the movement of the vocal cords and airflow rate will be assessed.
Read the detailed description
In this study, in patients who will be treated in our intensive care unit between 01.07.2024 and 01.12.2025 and who are deemed suitable for decannulation after tracheostomy [patients must be clinically stable, have been able to stay off the ventilator for at least 48 hours and have appropriate arterial blood gases taken during this time, have no dyspnea, GCS>10, have swallowing and cough reflexes, have no problems with mouth opening, and have secretions less than 1/3 of the length of a catheter (1)], the position of the vocal cords (right, left, cadaveric, normal), movements with phonation and respiration, and vocal fold displacement velocity (VFDV) to control air permeability will be measured by bedside ultrasound by deflating the cuff of the tracheostomy cannula, the cannula will be removed and the same measurements will be taken again with ultrasonography, before being transferred to the otolaryngology clinic (OT) for Flexible Endoscopic Evaluation of Swallowing (FEES) exam. The accuracy of the measurement will be confirmed by two researchers by video recording, and the findings will be compared with the FEES examination. Additionally, demographic characteristics, comorbidities, acute physiology and chronic health assessment scores (APACHEII), sequential organ failure assessment score (SOFA), comorbidities, decannulation failure (repeat tracheostomy or intubation within 2 days after decannulation) and prognosis (90 day-mortality) after decanulation will be recorded for patients meeting the above criteria.
- Conditions
- Decanulation
- Being tested
- ultrasound guided airway examination
- Keywords
- Ultrasound, decanulation, critically illness, weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided airway examinationDevice
the position of the vocal cords (right, left, cadaveric, normal), movements with phonation and respiration, and vocal fold displacement velocity (VFDV) to control air permeability will be measured by bedside ultrasound by deflating the cuff of the tracheostomy cannula, the cannula will be removed and the same measurements will be taken again with ultrasonography, before being transferred to the otolaryngology clinic (OT) for Flexible Endoscopic Evaluation of Swallowing (FEES) exam
| Study group | Role | What they receive |
|---|---|---|
| suitable for decannulation after tracheostomy within the specified date range | Patients who were deemed suitable for decannulation after tracheostomy within the specified date range and who underwent FEES by an otolaryngologist Receives: Device: ultrasound guided airway examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway examination with ultrasound for decanulation
This study aimed to observe at what doppler velocity values (cm/s) successful decannulation (168 hours without ventilation) could be achieved in patients.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Jul 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DecanulationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (estimated)
- Target duration
- 15 Months
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Küçükdemirci Kaya, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306091
- Sponsor's protocol ID
- BursaUludag ( 2024-10/15)
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Decannulation With Critically Ill Patients; a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07306091
- Acronym / sponsor ID
- BursaUludag ( 2024-10/15)
- Conditions
- Decanulation
- Keywords
- Ultrasound, decanulation, critically illness, weaning
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 29 Dec 2025 (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.
Purpose of the Study: To predict potential problems (such as shortness of breath and obstruction of the airway due to vocal cord immobility) before the tracheostomy cannula is removed, the patient's vocal cords, their movement, and airflow rate will be assessed at the bedside. The patient will also be examined using routine methods to identify these problems, and the results will be compared with ultrasound scans. The study aims to determine the success and failure of ultrasound in detecting these problems. Method and Procedures: While the patient is receiving treatment in the intensive care unit, the probe of the existing ultrasound device will be placed on the patient's neck, over the cannula, and the movement of the vocal cords and airflow rate will be assessed.
Detailed description
In this study, in patients who will be treated in our intensive care unit between 01.07.2024 and 01.12.2025 and who are deemed suitable for decannulation after tracheostomy [patients must be clinically stable, have been able to stay off the ventilator for at least 48 hours and have appropriate arterial blood gases taken during this time, have no dyspnea, GCS>10, have swallowing and cough reflexes, have no problems with mouth opening, and have secretions less than 1/3 of the length of a catheter (1)], the position of the vocal cords (right, left, cadaveric, normal), movements with phonation and respiration, and vocal fold displacement velocity (VFDV) to control air permeability will be measured by bedside ultrasound by deflating the cuff of the tracheostomy cannula, the cannula will be removed and the same measurements will be taken again with ultrasonography, before being transferred to the otolaryngology clinic (OT) for Flexible Endoscopic Evaluation of Swallowing (FEES) exam. The accuracy of the measurement will be confirmed by two researchers by video recording, and the findings will be compared with the FEES examination. Additionally, demographic characteristics, comorbidities, acute physiology and chronic health assessment scores (APACHEII), sequential organ failure assessment score (SOFA), comorbidities, decannulation failure (repeat tracheostomy or intubation within 2 days after decannulation) and prognosis (90 day-mortality) after decanulation will be recorded for patients meeting the above criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| suitable for decannulation after tracheostomy within the specified date range | – | Device: ultrasound guided airway examinationPatients who were deemed suitable for decannulation after tracheostomy within the specified date range and who underwent FEES by an otolaryngologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critically ill patients whom suitable for decanulation after tracheostomy
Key inclusion criteria (4 listed)
- Critically ill patients (CIPs) who are receiving treatment within the specified time period and who require a tracheostomy.
- Critically ill patients who are suitable for decannulation (underwent spontaneous breathing trials with the use of CPAP ( CPAP level of maximum 6 cm of water and maximum 10 cm of water pressure support at least 24 hours ).
- Critically ill patients with intact swallowing reflexes ( patients were first examined for GAG reflexes, followed by ultrasonography; changes in muscle length and contraction velocity during swallowing were measured in a sagittal section using a convex probe ,
- CIPs with GCS>8.
Key exclusion criteria (2 listed)
- 1.Critically ill patients under 18 years of age. 2.Critically ill patients who do not require tracheostomy. 3.Critically ill patients who are spontaneously breathing and can be weaned off the ventilator for <24 hours 4.Critically ill patients with GCS < 8. 5.Critically ill patients with absent swallowing reflexes
- -
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 |
|---|---|---|
| ultrasound guided airway examinationthe position of the vocal cords (right, left, cadaveric, normal), movements with phonation and respiration, and vocal fold displacement velocity (VFDV) to control air permeability will be measured by bedside ultrasound by deflating the cuff of the tracheostomy cannula, the cannula will be removed and the same measurements will be taken again with ultrasonography, before being transferred to the otolaryngology clinic (OT) for Flexible Endoscopic Evaluation of Swallowing (FEES) exam | Device | suitable for decannulation after tracheostomy within the specified date range |
Primary outcome
Airway examination with ultrasound for decanulation
Time frame: 15 months
This study aimed to observe at what doppler velocity values (cm/s) successful decannulation (168 hours without ventilation) could be achieved in patients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Yes
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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.
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 Decanulation, run by Uludag University at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 29 Dec 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
Airway examination with ultrasound for decanulation (time frame: 15 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 29 Dec 2025.