NCT06138093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

December 20, 2024

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

November 7, 2023

Last Update Submit

December 17, 2024

Conditions

Tracheostomy

Keywords

tracheostomyrespiratory insufficiencyrespiratory function testsmechanical ventilatorsrehabilitationcritical care

Outcome Measures

Primary Outcomes (4)

  • Forced expiratory volume in one second (FEV1)

    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

    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)

    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)

    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

Study Arms (1)

Sealed / closed tracheostomy

EXPERIMENTAL

Sealing of the tracheostomy wound using a sealing device.

Device: Sealing deviceDevice: No device

Interventions

Sealing deviceDEVICE

Intratracheal tracheostomy sealing

Sealed / closed tracheostomy
No deviceDEVICE

Open tracheostomy wound

Sealed / closed tracheostomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Tracheostomy for minimum 7 days
  • Age \> 18 years
  • Capped uncuffed tube size 7 or 8 for at least 24 hours

You may not qualify if:

  • Cognitive dysfunction (patients who are not able to cooperate with investigation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology and Intensive Care, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (1)

  • Kraghede RE, Christiansen KJ, Kaspersen AE, Pedersen M, Petersen JJ, Hasenkam JM, Devantier L. Novel Method for Sealing Tracheostomies Immediately after Decannulation-An Acute Clinical Feasibility Study. Biomedicines. 2024 Apr 12;12(4):852. doi: 10.3390/biomedicines12040852.

    PMID: 38672206DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Rasmus E Kraghede, MD

    Department of Anaesthesiology and Intensive Care, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

  • J. Michael Hasenkam, MD, DMSc

    Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2023

First Posted

November 18, 2023

Study Start

February 28, 2020

Primary Completion

January 12, 2022

Study Completion

June 1, 2023

Last Updated

December 20, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)