Consequence of Open Versus Closed Tracheostomy Immediately After Decannulation

Aarhus University Hospital

Status: Completed

Conditions: Tracheostomy

Treatments: Device: No device; Device: Sealing device

Study type: Interventional

Funder types: Other

Identifiers

NCT06138093

74553

Details and patient eligibility

About

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.

Full description

See protocol document.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Sealed / closed tracheostomy

Experimental group

Description:

Sealing of the tracheostomy wound using a sealing device.

Treatment:

Device: Sealing device

Device: No device