Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202402619757376 Date of Registration: 13/02/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative Study between Laryngeal Ultrasound and Cuff Leak Test in Predicting Post Extubation Airway Edema in Head and Neck Surgeries
Official scientific title Comparative Study between Laryngeal Ultrasound and Cuff Leak Test in Predicting Post Extubation Airway Edema in Head and Neck Surgeries
Brief summary describing the background and objectives of the trial Endotracheal intubation is an important procedure which is indicated in several clinical situations. However, complications followed the intubation or extubation such as post-extubation edema is considered one of the most frequent causes of reintubation, prolonged mechanical ventilation, and increased morbidity in patients. Laryngeal ultrasound is a new and non-invasive method of examining the airway anatomy. Cuff leak test (CLT) is a non-invasive and easily performed clinical test that has been traditionally used to predict airway narrowing in intubated patients. This study aims to decrease the risk of post extubation complications by evaluating the value of Laryngeal ultrasound and cuff leak test in predicting post extubation airway edema in head and neck surgeries.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ear, Nose and Throat
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/03/2024
Actual trial start date
Anticipated date of last follow up 30/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 77
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group leak test versus once at the end of surgery once before extubation at the end of surgery The cuff leak will be measured when the patient presumed ready for extubation. The procedure will be performed according to the protocol proposed by (Miller & Cole, 1996). Before the test measurement, oral and endotracheal secretions will be suctioned, and the ventilators will be placed on the assist-control mode. Tidal volumes will be measured with the cuff inflated and deflated. Six subsequent breath cycles will be measured, and the average value will be calculated. The leak volume will be defined as a difference between expiratory tidal volumes with the cuff inflated and deflated, 10% of predetermined tidal volume has been used to identify patients at risk for post-extubation stridor 77 Uncontrolled
Experimental Group layngeal ultrasound once at the end of surgery once before extubation at the end of surgery The laryngeal US will be performed with a Medisone-accuvix-v10-probe liner (7/5 MHz) for the visualization of the vocal cords according to the protocol described by Ding et al., (2006). All US measurements will be performed by an expert radiologist (M.K.T) who will be blinded to the results of the study. Patients will be put in supine position while the neck is hyper-extended. The test will be performed with the same settings as the CLT with the balloon cuff inflated and deflated. The laryngeal air column width will be defined as the width of air passed through the vocal cords as determined by US. It will be recorded for three consecutive times, and the averaged value will be recorded. The air-column width difference (ACWD) was the width difference between balloon-cuff inflation and deflation. less than 0.9 mm was the threshold value for predicting post extubation stridor. 77
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria: - American Society of Anesthesiologists I and II. - Age: 18-60 years. - Gender: both genders. - Intubated and mechanically ventilated for a minimum of 3 h. - Patients who are ready for extubation. Exclusion criteria: - Patients refused to participate in the study. - Patients documented vocal cord (VC) abnormalities and dysfunction. - Patients with laryngeal carcinoma - Patients with neck radiotherapy. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/01/2024 research ethics committee suez canal university faculty of medicine
Ethics Committee Address
Street address City Postal code Country
ring road ismailia ,egypt ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Post extubation edema: will be assessed. If the patient had Post extubation edema, he will be recorded as positive. While if not occurred, he will be recorded as negative among both groups. once at end of surgery before extubation
Secondary Outcome sore throat after extubation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
suez canal university hospital ring road kilo 4.5 ismailia 014552 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded ring road ismailia egypt ismailia 41522 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor self funded ring road ismailai egypt ismailia 41522 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ahmed abdelrahman ahmedabdelrahman29@gmail.com 0201002744572 ring road ismailia egypt
City Postal code Country Position/Affiliation
ismailia 41522 Egypt consultant
Role Name Email Phone Street address
Public Enquiries mostafa elsaeed ahmedabdelrahman29@gmail.com 0201020498984 ring road ismailia egypt
City Postal code Country Position/Affiliation
ismailia 41522 Egypt consultant
Role Name Email Phone Street address
Scientific Enquiries ahmed abdelrahman ahmedabdelrahman29@gmail.com 0201002744572 ring road
City Postal code Country Position/Affiliation
ismailia 41522 Egypt consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes excel sheet containning patient data witout revieling identity, statistical analysis and results. Clinical Study Report,Study Protocol by the end of study during publication shared pdf
URL Results Available Results Summary Result Posting Date First Journal Publication Date
will be available by the end of results No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information