Skip to main content
OpenTrials
Completed

NCT Number: NCT06138093

Consequence of Open Versus Closed Tracheostomy Immediately After Decannulation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tracheostomy Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology and Intensive Care, Aarhus University Hospital

Aarhus, 8200, Denmark

About this study

See protocol document.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sealing Device

Device

Intratracheal tracheostomy sealing

No device

Device

Open tracheostomy wound

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Nov 18, 2023
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.