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.: PACTR202204474067468 Date of Approval: 28/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Tracheal Intubation in Patients with Simulated Cervical Immobilization: A Comparison between Two Intubation Devices
Official scientific title Tracheal Intubation in Patients with Simulated Cervical Immobilization: A Comparison between Two Intubation Devices
Brief summary describing the background and objectives of the trial Endotracheal intubation is established as the gold standard for securance of the airway. Excessive neck extension during tracheal intubation may cause serious complications, including spinal cord injury especially in patients with an unstable cervical spines. The Video Stylet (VS) is a novel device for endotracheal intubation recently introduced into practice with early clinical success. Due to its dynamic flexible tip and rigid sheath, it bridges the gap between the flexible and rigid intubation endoscopes and have been used successfully in patients with limited neck extension and mouth opening. The aim of the present study is to compare the clinical performance of C-MAC video stylet and C-MAC D-Blade video laryngoscope during oral intubation in anaesthetized patients with simulated cervical spine immobilization.
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 Treatment: Devices
Anticipated trial start date 01/05/2022
Actual trial start date
Anticipated date of last follow up 31/10/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL N/A
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Video stylet N/A During the whole procedure of intubation clinical performance of C-MAC video stylet during intubation and radiological imaging of cervical spine motion 26
Control Group D blade video Laryngoscope N/A During the whole procedure of intubation clinical performance of C-MAC D-Blade video laryngoscope during intubation and radiological imaging of cervical spine motion 26 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients scheduled for elective surgery under general anaesthesia with endotracheal intubation. - Patient refusal - Clinical or radiographic evidence of C spine abnormality or air way trauma - Simplified airway risk index ≥ 4 - Morbid obesity (BMI ≥ 40) - Previous neck surgery - Pregnancy - Mouth opening less than two fingers - Full stomach Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 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 20/10/2021 The Ethics Committee of the Faculty of Medicine Alexandria University IRB No 00012098
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Messalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Duration of the first successful intubation attempt Whole time of intubation procedure
Secondary Outcome Number of intubation attempts During the whole procedure
Secondary Outcome Degree of cervical spine movement During the whole procedure
Secondary Outcome Degree of stress associated with this intubation 5 minutes after the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
General Surgery Department Medical research institute Alexanderia Uneversity 169 elhorreya street, Al Ibrahimeyah Qebli WA Al Hadrah Bahri, Bab Sharqi Alexandria 21561 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Adel Saeed Mohamed Anany 169 elhorreya street, Al Ibrahimeyah Qebli WA Al Hadrah Bahri, Bab Sharqi Alexandria 21561 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Medical Research Institute Alexandria University 169 elhorreya street, Al Ibrahimeyah Qebli WA Al Hadrah Bahri, Bab Sharqi Alexandria 21561 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Emad Eldin Abd El Monem Arida 17 champolllion street Al Mesallah Sharq, Al Attarin Alexandria 21521 Egypt
Magda Mohamed Abo Ollo 169 elhorreya street, Al Ibrahimeyah Qebli WA Al Hadrah Bahri, Bab Sharqi Alexandria 21561 Egypt
Hossam Eldin Fouad Rida 17 champolllion street Al Mesallah Sharq, Al Attarin Alexandria 21521 Egypt
Walid Mohamed Ahmed Mohamed 169 elhorreya street, Al Ibrahimeyah Qebli WA Al Hadrah Bahri, Bab Sharqi Alexandria 21561 Egypt
Eman Ahmed Mohamed ElAttar 169 elhorreya street, Al Ibrahimeyah Qebli WA Al Hadrah Bahri, Bab Sharqi Alexandria 21561 Egypt
Adel Saeed Mohamed 169 elhorreya street, Al Ibrahimeyah Qebli WA Al Hadrah Bahri, Bab Sharqi Alexandria 21561 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Principal Investigator Emadeldin Arida aridar@yahoo.com 00201223129135 17 champolllion street Al Mesallah Sharq, Al Attarin
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Anaesthesia and Surgical Intensive Care Faculty of Medicine Alexandria university
Role Name Email Phone Street address
Scientific Enquiries Magda AboOllo magdaaboollo@Hotmail.com 00201222220214 169 elhorreya street, Al Ibrahimeyah Qebli WA Al Hadrah Bahri, Bab Sharqi
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Professor of Anaesthesia and Pain Management Medical research Institute Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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