Consequence of Open Versus Closed Tracheostomy Immediately After Decannulation

Not Applicable

Completed

• Conditions: Tracheostomy
• Interventions: Device: Sealing device; Device: No device

• Registration Number: NCT06138093
• Lead Sponsor: Aarhus University Hospital

Brief 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.

Detailed Description

See protocol document.

Study Timeline

• Study Start: 2020-02-28
• Primary Completion: 2022-01-12
• Study Completion: 2023-06-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-13
• Study First Posted: 2023-11-18
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sealed / closed tracheostomy	No device	Sealing of the tracheostomy wound using a sealing device.
Sealed / closed tracheostomy	Sealing device	Sealing of the tracheostomy wound using a sealing device.

Primary Outcome Measures

Name	Time	Method
Forced expiratory volume in one second (FEV1)	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	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)	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)	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

Trial Locations

Locations (1)

Department of Anaesthesiology and Intensive Care, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark