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.: PACTR202109682609409 Date of Registration: 16/09/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The utility of ultrasound in the prediction of difficult laryngoscopy
Official scientific title The utility of ultrasonography in the assessment of difficult laryngoscopy: A prediction accuracy study
Brief summary describing the background and objectives of the trial Difficult intubation, is associated with significant morbidity and mortality. Ultrasound is a promising tool that offers a morphological study of anatomical structures that may interfere with upper airway management. The aim of this study is to evaluate the association of ultrasonographic measurements with difficult laryngoscopy and to establish a new predictive score of difficult laryngoscopy. For that, we conducted a prospective observational study and enrolled patients proposed for surgery under general anesthesia with orotracheal intubation. After collecting demographic and clinical data, we will evaluate 8 ultrasound measurements. After induction of general anesthesia, the sample will be (randomly) separated into 2 groups: easy laryngoscopy (EL: CLG I and II) and difficult laryngoscopy (DL: CLG III and IV). Univariate analysis and multivariable logistic regression will then be performed to test associations between clinical and sonographic measurements and difficult laryngoscopy
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/01/2021
Actual trial start date 02/01/2021
Anticipated date of last follow up 30/04/2021
Actual Last follow-up date 21/04/2021
Anticipated target sample size (number of participants) 205
Actual target sample size (number of participants) 200
Recruitment status Completed
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
Crossover: all participants receive all interventions in different sequence during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Ultrasonography of the anterior cervical region 5 minutes we evaluated 8 ultrasound measurements using an abdominal probe to calculate the saigittal and coronal diameter of the tongue, the hyomental distance in a neutral and an extended position and their ratio. Then using a linear probe, we evaluated the thickness of the anterior neck soft tissues at three levels : the hyoid bone, the epiglottis and the trachea at the suprasternal notch 159 Uncontrolled
Experimental Group Ultrasonography of the anterior cervical region 5 minutes we evaluated 8 ultrasound measurements using an abdominal probe to calculate the saigittal and coronal diameter of the tongue, the hyomental distance in a neutral and an extended position and their ratio. Then using a linear probe, we evaluated the thickness of the anterior neck soft tissues at three levels : the hyoid bone, the epiglottis and the trachea at the suprasternal notch. After this, airway management was performed and the Cormack and Lehane Grade was III or IV so the laryngoscopy was difficult. 41
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- patients older than 18 years of age, of either sex, - with an American Society of Anesthesiologists (ASA) score of I, II or III, - candidates for elective procedures under general anesthesia with endotracheal intubation and direct laryngoscopy after receiving a myorelaxant - impossibility to obtain an acoustic window - modification of the anesthesia or airway management protocol - suspicion of subglottic stenosis after intubation - Intubation operator considered inexperienced: experience <1.5 years - incapacity to evaluate clinical criteria: craniofacial and cervical trauma - incapacity of the patient to give his consent: dementia, agitation, altered state of consciousness, - conditions requiring the use of videolaryngoscopy or fibroscopy : inter-incisor gap<2,5 cm et /ou fixed cervical spine, - contraindication to propofol and/or succinylcholine, - Pregnancy and 6 first weeks postpartum, - abnormalities and malformations of the upper airways, - a thyroid goiter - a tracheostomy. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 95 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 07/11/2020 Southern protection committee of people
Ethics Committee Address
Street address City Postal code Country
Menzel Chaker Street, Sfax Sfax 3003 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Difficult laryngoscopy defined by the absence of vision of the glottis, either a Cormack and Lehane class III or IV without external laryngeal maneuver 20 minutes
Secondary Outcome Difficult intubation defined according to the expert conference of the French society of anesthesia reanimation (SFAR) of 2006 as an intubation requiring more than two laryngoscopies and / or the implementation of an alternative technique after optimization of the position of the head (Jackson's amended), with or without external laryngeal manipulation (BURP: backwards, upwards and rightwards pressure) 25 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Habib Bourguiba University Hospital Road Al Firdaws Sfax 3029 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Karim Bouzid Merkez el Jilani, Road n275, Mohamed Ibn Fadhl Sfax 3042 Tunisia Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Karim Bouzid karimbouzid7@yahoo.fr +21620907711 Merkez el Jilani, Street n275, Mohamed Ibn Fadhl
City Postal code Country Position/Affiliation
Sfax 3042 Tunisia Medical Resident in anesthesiology and critical care
Role Name Email Phone Street address
Public Enquiries Anas Kammoun anaskammoun93@gmail.com +21626699735 Kaied Mohamed Street km 6
City Postal code Country Position/Affiliation
Sfax 3000 Tunisia Medical resident in anesthesiology and critical care
Role Name Email Phone Street address
Scientific Enquiries Salma Ketata slayma@hotmail.com +21696107594 Menzel Chaker street km 7
City Postal code Country Position/Affiliation
Sfax 3000 Tunisia Senior physician in anesthesiology and critical care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol No time frame - Qualified researchers engaging in independent scientific research can have open access. - Study protocol, Infomed consent, data collected (spss file) and statistical methods and files will be shared - The investigator will decide to give access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 31/08/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 31/08/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information