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.: PACTR202306740935710 Date of Approval: 09/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Hyomental Distance Measured Ultrasonography versus weight-based criteria for laryngeal mask size selection in children. A prospective, Randomised Observational Study
Official scientific title Hyomental Distance Measured Ultrasonography versus weight-based criteria for laryngeal mask size selection in children. A prospective, Randomised Observational Study
Brief summary describing the background and objectives of the trial The feasibility of using ultrasound examination to confirm LMA placement had been compared with clinical tests and fiberoptic laryngoscopy in females scheduled for gynecologic surgery. The placement was confirmed as acceptable in 89.1% by clinical tests, 59.4% by fiberoptic laryngoscope assessment and 67.2% by ultrasound examination. Concerning patients classified with high oropharyngeal leaks, there were no differences in confirmation of acceptable placement between clinical tests and ultrasound examinations, but the number of patients determined to have acceptable placement by ultrasound examination was greater than that determined by fiberoptic laryngoscopy. The study concluded that ultrasound examination is a superior technique for confirming the seal on the LMA.This prospective, observational study aims to assess the efficacy and safety of ultrasonographic measured hyomental distance in the optimization of LMA placement in pediatric patients. - In pediatric surgery and emergencies, LMA represents a useful airway management device for routine and difficult airway management. - Inserting an improper LMA size may result in malposition, displacement within the hypopharynx, and failed ventilation that needs repositioning. - Selection of the size of LMA represents a major challenge for anesthesiologists, especially in children. - The ultrasonographic measured hyomental distance showed a correlation with the length of the pharyngeal cavity. - Optimization of the size of the inserted LMA can be confirmed either clinically, ultrasonographic or through the fiberoptic laryngoscope. - The ultrasonographic measured hyomental distance confirmed the optimization of LMA with results comparable to that of the clinical methods and better than those of the fiberoptic laryngoscope. OBJECTIVES 1) To assess the airway of all included children; clinically and ultrasonographic. 2) To measure the hyomental distance ultrasonographically before and after insertion of the LMA. 3) Select the size of LMA according to the patient’s weight as recommended by producers. 4) To assess the state of ventilation of the patient after insertion of the LMA. 5) To assess the position of the inserted LMA in the pharyngeal cavity during anaesthesia. 6) To correct any malposition or displacement of the inserted LMA according to the measured hyomental distance. 7) To reassess the state of ventilation and position of the LMA after correction. 8) To tabulate and analyze the collected data.
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 05/04/2023
Actual trial start date 05/04/2023
Anticipated date of last follow up 05/10/2023
Actual Last follow-up date 05/10/2023
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Active, not 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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group CONTROL during the whole procedure (30 patients): where size selection will be based on weight guide.- At an acceptable depth of anaesthesia, LMA will be placed after size selection according to weight as recommended by the producer. 30 Active-Treatment of Control Group
Experimental Group hyomental distance group during the whole procedure hyomental distance group (30 patients): where the size of LMA will be according to measured hyomental distance by ultrasound as follows: • If Less than 2 cm: LMA size 2 will be used. • If 2-3 cm: LMA size 2.5 will be used. • If more than 3 cm: LMA size 3 will be used. - LMA placement will be imaged by the US. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion Criteria: a- Parents’ acceptance. b- Age: between 3-14 years. c- Sex: Both male and female. d- Physical Status: American Society of Anesthesiologists (ASA) I & II) Exclusion Criteria: a- Developmental Delay (mental and physical growth retardation). b- Hypersensitivity to any type of used drugs. c- Patient with a difficult airway ( according to thyromental height and the Mallampati test) d- Patients with a history of neck surgery, airway malformation, upper respiratory tract infection, congenital heart disease or risk of aspiration. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 3 Year(s) 14 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 09/01/2023 Scientific Research Ethics Committee Kafrelsheikh university faculty of medicine
Ethics Committee Address
Street address City Postal code Country
El Geish street, Kafrelsheikh , Egypt Kafrelsheikh 33511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the correct rate of the predicted LMA size without needing size adjustment or employing other devices. During the study period
Secondary Outcome 2- Secondary outcomes included injury rate (defined as visible blood stains on LMA upon removal), OLP value, many insertion attempts (defined as re-insertion after complete LMA removal from the oral cavity), Patient characteristics and operative data: age, sex, ASA, body weight, duration of anaesthesia & surgery. - Heart rate (HR), oxygen saturation (SpO2) and noninvasive blood pressure - (NIBP), End Tidal Carbon Dioxide (EtCO2 ) & Peak Inspiratory Pressure (PIP ) will be recorded every 5 minutes intraoperative. - Data collected from monitoring will be recorded individually for analysis and presentation. During the study period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kafrelsheikh University Hospitals El geish street , Kafrelsheikh , Egypt Kafrelsheikh 33511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sherif Kamal hafez Arafa 12 Tout Angh Amoun street Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor sherif kamal hafez arafa 12 tout Angh Amiun street Tanta 31527 Egypt Individual
Secondary Sponsor sherif kamal hafez arafa 12 tout Angh Amiun street Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
sherif kamal hafez arafa 12 Tout Angh Amoun street Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator sherif arafa sherifarafa1020@gmail.com 00201005714014 12 Tout Angh Amiun street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt assisstant professor of anesthesia and surgical ICU
Role Name Email Phone Street address
Public Enquiries sherif arafa sherifarafa1020@gmail.com 00201005714014 12 Tout Angh Amiun street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt assisstant professor of anesthesia and surgical ICU
Role Name Email Phone Street address
Scientific Enquiries Amir Abuzikary aabozikry@yahoo.com 00201016326544 23 Mohb street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt assisstant professor of anesthesia and surgical ICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported in article after deidentification (text, tables,figure and appendices) Study Protocol Beginning 9 months and ending 36 months following article publication Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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