Consequence of Open Versus Closed Tracheostomy Immediately After Decannulation

NCT ID: NCT06138093

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-28

Study Completion Date

2023-06-01

Brief Summary

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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

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See protocol document.

Conditions

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Tracheostomy

Keywords

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tracheostomy respiratory insufficiency respiratory function tests mechanical ventilators rehabilitation critical care

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sealed / closed tracheostomy

Sealing of the tracheostomy wound using a sealing device.

Group Type EXPERIMENTAL

Sealing device

Intervention Type DEVICE

Intratracheal tracheostomy sealing

No device

Intervention Type DEVICE

Open tracheostomy wound

Interventions

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Sealing device

Intratracheal tracheostomy sealing

Intervention Type DEVICE

No device

Open tracheostomy wound

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rasmus E Kraghede, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology and Intensive Care, Aarhus University Hospital

J. Michael Hasenkam, MD, DMSc

Role: STUDY_CHAIR

Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital

Locations

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Department of Anaesthesiology and Intensive Care, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 38672206 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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74553

Identifier Type: -

Identifier Source: org_study_id