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.: PACTR202312917896121 Date of Approval: 06/12/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative evaluation of two supraglottic airway devices: intubating laryngeal mask airway ( ILMA) and Ambu Aura I for blind tracheal intubation in adults.
Official scientific title Comparative evaluation of two supraglottic airway devices: intubating laryngeal mask airway (ILMA) and Ambu Aura I for blind tracheal intubation in adults.
Brief summary describing the background and objectives of the trial Laryngeal mask airways are supraglottic airway devices which may be used as temporary method to maintain an open airway during the administration of Anasthesia or as an immediate life saving measure in a patient with a difficult or failed airway. This study will compare between two types of supraglottic airways as regard blind tracheal intubation in adults
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 No
Anticipated trial start date 01/10/2022
Actual trial start date 01/10/2022
Anticipated date of last follow up 31/10/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status 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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intubating Laryngeal mask airway Propofol 2mg/kg Tracium 0.5mg/kg Dormicum 0.03mg/kg Atropine 0.01mg/kg Whole operation Induction of Anasthesia by propofol, tracium, fentanyl Insertion of ILMA Time recording from taking supraglottic airway in hand till insertion Blind tracheal intubation through the device by 2 attempt first when patient 's head in neutral position if failed maneuver of backward upward thyroid pressure If failed conventional laryngoscopy will be done Recording of vital data heart rate, blood pressure SPo2 Recording of complications such as trauma to airway,sore throat, hoarseness of voice 50
Control Group Ambu Aura I Propofol 2mg/kg Tracium 0.5mg/kg Fentanyl 2mcg/kg Dormicum 0.03mg/kg Atropine 0.01mg/kg Whole operation Induction of Anasthesia with propofol, tracium, fentanyl Insertion of Ambu Aura I and confirmation via easy bag ventilation Blind intubation via Ambu Aura I and confirmation of tube via capnography Assess primary and secondary outcomes. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Age between 18and 60years. 2.American society of anesthesiologists I &II 3.Patients are being scheduled to undergo elective surgical procedures requiring tracheal intubation. 1.Patient's refusal. 2.Patients with known or predicted difficult airway such as malampati III or IV, mouth opening less than 2.5cm and thyromental distance less than 4 cm. 3.Patients with poor lung compliance, restricted neck movements, oropharyngeal pathology. 4.Patients with risk of gastric aspiration i.e., obesity,hiatal hernia,gastroparesis, pregnancy or trauma. 5.Body mass index > 35 kg/m2 Adult: 19 Year-44 Year 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 28/03/2022 Research Ethics Committee Faculty of Medicine Ain Shams university
Ethics Committee Address
Street address City Postal code Country
18 El Abbasia square next to Alnour mosque Cairo 1183 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome First attempt success rate for blind endotracheal intubation through the supraglottic airway device. First attempt
Secondary Outcome 1.Total time required for the successful blind endotracheal intubation through the supraglottic device 2.Ease of placement of supraglottic airway device as regard a. Number of attempts required for the placement of the supraglottic airway device. b.Time required for the placement of the supraglottic airway device. Immediate after induction of Anasthesia
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Ain Shams university 38 Abbasia square next to Alnour mosque Cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain shams university 38 Abbassia next to Al Nour mosque Cairo 1181 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Ain Shams university 38 Abbasia square next to Alnour mosque Cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dina Galal Abo dief 14Mohamed Salem Street,Elmataria Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Abdel Maksoud aboadham2001@hotmail.com 01097788381 El Rehab
City Postal code Country Position/Affiliation
Cairo Egypt Assistant professor of Anasthesia and intensive care
Role Name Email Phone Street address
Public Enquiries Dina Galal dina76795@gmail.com 01011237339 14mohamed Salem Street Elmataria
City Postal code Country Position/Affiliation
Cairo Egypt Assistant lecturer of Anasthesia and intensive care.
Role Name Email Phone Street address
Scientific Enquiries Adel Mikhail amikhaeal@hotmail.com 01227817112 El Abbasia
City Postal code Country Position/Affiliation
Cairo Egypt Professor of Anasthesia and intensive care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of individual participant data collected during the trial after deidentification. Statistical Analysis Plan Following publication Any purpose
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