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Consequence of Open Versus Closed Tracheostomy Immediately After Decannulation

NCT06138093 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-12-20

No results posted yet for this study

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.

Conditions

  • Tracheostomy

Interventions

DEVICE

Sealing device

Intratracheal tracheostomy sealing

DEVICE

No device

Open tracheostomy wound

Sponsors & Collaborators

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Rasmus E Kraghede, MD · Department of Anaesthesiology and Intensive Care, Aarhus University Hospital

  • J. Michael Hasenkam, MD, DMSc · Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-28
Primary Completion
2022-01-12
Completion
2023-06-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06138093 on ClinicalTrials.gov