Decanulation in Critically Ill Patients

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: Enrolling by invitation
• Conditions: Decanulation
• Intervention / Treatment: Device: ultrasound guided airway examination

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: Observational
• Enrollment (Estimated): 107

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Airway examination with ultrasound for decanulation	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

• Sponsor: Uludag University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Ultrasound; weaning; critically illness; decanulation
• Other Study ID 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