NCT07306091

Decanulation in Critically Ill Patients

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 107 (estimated)
• Sponsor: Uludag University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Decanulation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-12-31
• Completion: 2026-02-01
• First posted: 2025-12-29
• Last updated: 2025-12-29

Locations

1 site across 1 country: Turkey (Türkiye)