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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.
See protocol document.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sealed / closed tracheostomy | Experimental | Sealing of the tracheostomy wound using a sealing device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sealing device | Device | Intratracheal tracheostomy sealing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume in one second (FEV1) | Lung function / air flow evaluated by spirometry | 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 | 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 | 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 | Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rasmus E Kraghede, MD | Department of Anaesthesiology and Intensive Care, Aarhus University Hospital | Principal Investigator |
| J. Michael Hasenkam, MD, DMSc | Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology and Intensive Care, Aarhus University Hospital | Aarhus | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38672206 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 22, 2020 | Nov 7, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| No device |
| Device |
Open tracheostomy wound |
|