Consequence of Open Versus Closed Tracheostomy Immediately After Decannulation

December 17, 2024 updated by: Aarhus University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See protocol document.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Department of Anaesthesiology and Intensive Care, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sealed / closed tracheostomy
Sealing of the tracheostomy wound using a sealing device.
Device: Sealing device
Intratracheal tracheostomy sealing
Device: No device
Open tracheostomy wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
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
Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
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
Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
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
Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Investigators

  • Principal Investigator: Rasmus E Kraghede, MD, Department of Anaesthesiology and Intensive Care, Aarhus University Hospital
  • Study Chair: J. Michael Hasenkam, MD, DMSc, Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2020

Primary Completion (Actual)

January 12, 2022

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 74553

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tracheostomy

Clinical Trials on Sealing device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe