Ultrasound-guided Decannulation With Critically Ill Patients; a Prospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- Airway examination with ultrasound for decanulation
Study Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
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 <
- •5.Critically ill patients with absent swallowing reflexes
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Pınar Küçükdemirci Kaya
associated proffesor
Uludag University