TracheostomyNCT06138093
Consequence of Open Versus Closed Tracheostomy Immediately After Decannulation
A study testing Sealing device and No device in people with Tracheostomy, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Tracheostomy is performed for prolonged mechanical ventilation. Ineffective bandaging following decannulation leaves the tracheostomy wound unsealed, reducing pulmonary function, coughing ability, and voice quality, ultimately leading to decannulation failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy
- What is being tested?
- Sealing device and No device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Feb 2020to 1 Jun 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
- Tracheostomy for minimum 7 days
- Age > 18 years
- Capped uncuffed tube size 7 or 8 for at least 24 hours
Who cannot join
- Cognitive dysfunction (patients who are not able to cooperate with investigation)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anaesthesiology and Intensive Care, Aarhus University Hospital
Aarhus, 8200
About this study
Tracheostomy is performed for prolonged mechanical ventilation. Ineffective bandaging following decannulation leaves the tracheostomy wound unsealed, reducing pulmonary function, coughing ability, and voice quality, ultimately leading to decannulation failure. Recently, a new concept enabling intratracheal sealing of the tracheotomy was introduced, potentially solving the issues of air leakage and tracheal wound infection. This study aims to investigate the feasibility of intratracheal tracheostomy sealing in relation to an immediate normalization of physiological airway flow and an improved voice quality.
Read the detailed description
See protocol document.
- Conditions
- Tracheostomy
- Being tested
- Sealing device, No device
- Keywords
- tracheostomy, respiratory insufficiency, respiratory function tests, mechanical ventilators, rehabilitation, critical care
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sealing deviceDevice
Intratracheal tracheostomy sealing
No deviceDevice
Open tracheostomy wound
| Study group | Role | What they receive |
|---|---|---|
| Sealed / closed tracheostomy | Experimental | Sealing of the tracheostomy wound using a sealing device. Receives: Device: Sealing device; Device: No device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in one second (FEV1)
Lung function / air flow evaluated by spirometry
Measured: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
Voice quality
Evaluated by Equal-Appearing Interval Scale ranging from 1 to 5, where 5 represents a normal voice quality and 1 represents a severely impaired voice
Measured: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
Peak expiratory flow (PEF)
Lung function / air flow evaluated by spirometry
Measured: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
Forced vital capacity (FVC)
Lung function / air flow evaluated by spirometry
Measured: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start28 Feb 2020
- Primary completion12 Jan 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TracheostomyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rasmus E Kraghede, MD, Principal investigator, Department of Anaesthesiology and Intensive Care, Aarhus University HospitalJ. Michael Hasenkam, MD, DMSc, Study chair, Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138093
- Sponsor's protocol ID
- 74553
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kraghede RE, Christiansen KJ, Kaspersen AE, Pedersen M, Petersen JJ, Hasenkam JM, Devantier L. Novel Method for Sealing Tracheostomies Immediately after Decannulation-An Acute Clinical Feasibility Study. Biomedicines. 2024 Apr 12;12(4):852. doi: 10.3390/biomedicines12040852.
PubMed 38672206
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequence of Open Versus Closed Tracheostomy Immediately After Decannulation
- ClinicalTrials.gov ID
- NCT06138093
- Acronym / sponsor ID
- 74553
- Conditions
- Tracheostomy
- Keywords
- tracheostomy, respiratory insufficiency, respiratory function tests, mechanical ventilators, rehabilitation, critical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 18 Nov 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.
Tracheostomy is performed for prolonged mechanical ventilation. Ineffective bandaging following decannulation leaves the tracheostomy wound unsealed, reducing pulmonary function, coughing ability, and voice quality, ultimately leading to decannulation failure. Recently, a new concept enabling intratracheal sealing of the tracheotomy was introduced, potentially solving the issues of air leakage and tracheal wound infection. This study aims to investigate the feasibility of intratracheal tracheostomy sealing in relation to an immediate normalization of physiological airway flow and an improved voice quality.
Detailed description
See protocol document.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sealed / closed tracheostomy | Experimental | Device: Sealing device, Device: No deviceSealing of the tracheostomy wound using a sealing device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Tracheostomy for minimum 7 days
- Age > 18 years
- Capped uncuffed tube size 7 or 8 for at least 24 hours
Key exclusion criteria (1 listed)
- Cognitive dysfunction (patients who are not able to cooperate with investigation)
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 |
|---|---|---|
| Sealing deviceIntratracheal tracheostomy sealing | Device | Sealed / closed tracheostomy |
| No deviceOpen tracheostomy wound | Device | Sealed / closed tracheostomy |
Primary outcome
Forced expiratory volume in one second (FEV1)
Time frame: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
Lung function / air flow evaluated by spirometry
Voice quality
Time frame: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
Evaluated by Equal-Appearing Interval Scale ranging from 1 to 5, where 5 represents a normal voice quality and 1 represents a severely impaired voice
Peak expiratory flow (PEF)
Time frame: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
Lung function / air flow evaluated by spirometry
Forced vital capacity (FVC)
Time frame: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
Lung function / air flow evaluated by spirometry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Derived from this study: PubMed 38672206Kraghede RE, Christiansen KJ, Kaspersen AE, Pedersen M, Petersen JJ, Hasenkam JM, Devantier L. Novel Method for Sealing Tracheostomies Immediately after Decannulation-An Acute Clinical Feasibility Study. Biomedicines. 2024 Apr 12;12(4):852. doi: 10.3390/biomedicines12040852.
- Individual participant dataSharing planned: No
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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.
Rasmus E Kraghede, MD principal investigator
Department of Anaesthesiology and Intensive Care, Aarhus University Hospital
J. Michael Hasenkam, MD, DMSc study chair
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sealing device and No device in people with Tracheostomy, run by Aarhus University Hospital 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 3 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: finished, as of the sponsor's last update on 20 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Forced expiratory volume in one second (FEV1) (time frame: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06138093, which also lists 1 linked publication.
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 20 Dec 2024.