Decanulation in Critically Ill Patients

December 18, 2025 updated by: Pınar Küçükdemirci Kaya, Uludag University

Ultrasound-guided Decannulation With Critically Ill Patients; a Prospective Cohort Study

Purpose of the Study: To predict potential problems (such as shortness of breath and obstruction of the airway due to vocal cord immobility) before the tracheostomy cannula is removed, the patient's vocal cords, their movement, and airflow rate will be assessed at the bedside. The patient will also be examined using routine methods to identify these problems, and the results will be compared with ultrasound scans. The study aims to determine the success and failure of ultrasound in detecting these problems. Method and Procedures: While the patient is receiving treatment in the intensive care unit, the probe of the existing ultrasound device will be placed on the patient's neck, over the cannula, and the movement of the vocal cords and airflow rate will be assessed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this study, in patients who will be treated in our intensive care unit between 01.07.2024 and 01.12.2025 and who are deemed suitable for decannulation after tracheostomy [patients must be clinically stable, have been able to stay off the ventilator for at least 48 hours and have appropriate arterial blood gases taken during this time, have no dyspnea, GCS>10, have swallowing and cough reflexes, have no problems with mouth opening, and have secretions less than 1/3 of the length of a catheter (1)], the position of the vocal cords (right, left, cadaveric, normal), movements with phonation and respiration, and vocal fold displacement velocity (VFDV) to control air permeability will be measured by bedside ultrasound by deflating the cuff of the tracheostomy cannula, the cannula will be removed and the same measurements will be taken again with ultrasonography, before being transferred to the otolaryngology clinic (OT) for Flexible Endoscopic Evaluation of Swallowing (FEES) exam. The accuracy of the measurement will be confirmed by two researchers by video recording, and the findings will be compared with the FEES examination. Additionally, demographic characteristics, comorbidities, acute physiology and chronic health assessment scores (APACHEII), sequential organ failure assessment score (SOFA), comorbidities, decannulation failure (repeat tracheostomy or intubation within 2 days after decannulation) and prognosis (90 day-mortality) after decanulation will be recorded for patients meeting the above criteria.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
107

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

  • Turkey (Türkiye)
      • Bursa, Turkey (Türkiye), 16140
        • Uludag Universty Faculty of MedicineDepartment of Anesthesiology and Reanimation, Bursa, Turkey

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

critically ill patients whom suitable for decanulation after tracheostomy

Description

Inclusion Criterias

  1. Critically ill patients (CIPs) who are receiving treatment within the specified time period and who require a tracheostomy.
  2. Critically ill patients who are suitable for decannulation (underwent spontaneous breathing trials with the use of CPAP ( CPAP level of maximum 6 cm of water and maximum 10 cm of water pressure support at least 24 hours ).
  3. Critically ill patients with intact swallowing reflexes ( patients were first examined for GAG reflexes, followed by ultrasonography; changes in muscle length and contraction velocity during swallowing were measured in a sagittal section using a convex probe ,
  4. CIPs with GCS>8.

Exclusion Criteria:

1.Critically ill patients under 18 years of age. 2.Critically ill patients who do not require tracheostomy. 3.Critically ill patients who are spontaneously breathing and can be weaned off the ventilator for <24 hours 4.Critically ill patients with GCS < 8. 5.Critically ill patients with absent swallowing reflexes

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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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
suitable for decannulation after tracheostomy within the specified date range
Patients who were deemed suitable for decannulation after tracheostomy within the specified date range and who underwent FEES by an otolaryngologist
Device: ultrasound guided airway examination
the position of the vocal cords (right, left, cadaveric, normal), movements with phonation and respiration, and vocal fold displacement velocity (VFDV) to control air permeability will be measured by bedside ultrasound by deflating the cuff of the tracheostomy cannula, the cannula will be removed and the same measurements will be taken again with ultrasonography, before being transferred to the otolaryngology clinic (OT) for Flexible Endoscopic Evaluation of Swallowing (FEES) exam

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Airway examination with ultrasound for decanulation
Time Frame: 15 months
This study aimed to observe at what doppler velocity values (cm/s) successful decannulation (168 hours without ventilation) could be achieved in patients.
15 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uludag University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BursaUludag ( 2024-10/15)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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.

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