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NCT06138093 Clinical Trial

Consequence of Open Versus Closed Tracheostomy Immediately After Decannulation

Tracheostomy Clinical Trial

Official title:
Consequence of Open Versus Closed Tracheostomy Immediately After Decannulation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06138093
Other study ID # 74553
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 28, 2020
Est. completion date June 1, 2023

Study information
Verified date November 2023
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Description:

See protocol document.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date June 1, 2023
Est. primary completion date January 12, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Tracheostomy for minimum 7 days - Age > 18 years - Capped uncuffed tube size 7 or 8 for at least 24 hours Exclusion Criteria: - Cognitive dysfunction (patients who are not able to cooperate with investigation)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Sealing device
Intratracheal tracheostomy sealing
• No device
Open tracheostomy wound

Locations
Country Name City State
Denmark Department of Anaesthesiology and Intensive Care, Aarhus University Hospital Aarhus

Sponsors (1)
Lead Sponsor Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lung function / air flow Evaluated by spirometry At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
Primary 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 At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
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