Decanulation in Critically Ill Patients

NCT07306091 | Enrolling By Invitation DMC

• 1 other identifier: BursaUludag ( 2024-10/15)
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Decanulation

Keywords

Ultrasound; decanulation; critically illness; weaning

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

ultrasound guided airway examination DEVICE

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

suitable for decannulation after tracheostomy within the specified date range

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

critically ill patients whom suitable for decanulation after tracheostomy

You may qualify if:

• Critically ill patients (CIPs) who are receiving treatment within the specified time period and who require a tracheostomy.
• 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 ).
• 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 ,
• CIPs with GCS\>8.

You may not qualify if:

• 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

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Uludag Universty Faculty of MedicineDepartment of Anesthesiology and Reanimation, Bursa, Turkey

Bursa, 16140, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated proffesor

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 29, 2025
• Study Start: July 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: February 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)