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.: PACTR202004869929528 Date of Approval: 16/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title C-MAC video stylet versus C-MAC D-Blade in morbidly obese patients
Official scientific title C-MAC video stylet versus C-MAC D-Blade in morbidly obese patients
Brief summary describing the background and objectives of the trial Recently, video laryngoscopy has gained an increasingly important role in the management of difficult and emergent laryngoscopy. The Difficult Airway Society has published guidelines recommending that all anesthesiologists should be trained with and had access to a video laryngoscope as a part of unanticipated difficult tracheal intubation algorithm. The D-Blade, which is a highly angulated video laryngoscopic blade, was added to the C-MAC system to increase the potential to manage difficult airways. The C-MAC Video-Stylet is designed as a combination of rigid and flexible intubation endoscope. The video stylet device consists of a solid, unchanneled rigid metal stylet similar to a flexible endoscope with a small video camera and light source at the tip. Airway management in morbidly obese adults is challenging due to anatomical and physiological changes that include difficulty with mask ventilation, rapid oxygen desaturation, and altered pharmacokinetics. The use of videolaryngoscopes should improve the laryngeal view in morbidly obese patients. Using C-MAC video stylet may improve the laryngeal view in morbidly obese patients and allowed for efficient endotracheal intubation. The aim of this study is to evaluate the efficacy of video stylet in intubating patients with expected difficult airway in comparison with D blade videolaryngoscopy
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/05/2020
Actual trial start date
Anticipated date of last follow up 30/11/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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
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
Control Group C MAC D blade videolaryngoscopy From induction of anesthesia till successful endotracheal intubation Endotracheal intuabtion using C-MAC D blade videolaryngoscopy 30 Active-Treatment of Control Group
Experimental Group C MAC video stylet From induction of anesthesia till successful endotracheal intubation Endotracheal intubation using C-MAC video stylet 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Morbidly obese patients with Simplified airway risk index (SARI) ≥ 4. Full stomach Seizures Pregnancy Airway trauma or tumors. Mouth opening less than 2 cm Coagulation disorders. 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 16/01/2020 Ethics Committee 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 The success of the first attempt of tracheal intubation From induction of anaesthesia till successful endotracheal intubation
Primary Outcome The overall success rate of tracheal intubation From induction of anaesthesia till successful endotracheal intubation
Secondary Outcome Number of attempts From induction of anaesthesia till successful endotracheal intubation
Secondary Outcome Time of the intubation procedure From induction of anaesthesia till successful endotracheal intubation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Madina womens hospital 25 elshaheed kamal el deen salah ezbet saad sidi gaber Alexandria 21529 Egypt
Medical research institute 165 Horreya road Al Hadara Alexandria 21561 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Maha Mahmoud Soliman Yakout 397 ElHorreya Avenue Mustafa Kamel Alexandria 21523 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Madina womens hospital 25 elshaheed kamal el deen salah ezbet saad sidi gaber Alexandria 21529 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Hatem Baghat Ahmed Abo Elwafa 370 ElHorreya Avenue Mustafa Kamel Alexandria 21523 Egypt
Adel Ibrahim Hassan Hozien El Horreya Avenue ElHadara Alexandria 21561 Egypt
Marwan Abdelzaher Elfakharany El Horreya Avenue ElHadara Alexandria 21561 Egypt
Maha Mahmoud Soliman Yakout 397 ElHorreya Avenue Mustafa Kamel Alexandria 21523 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adel Hozien adelhozien49@gmail.com 00201066062582 ElHorreya Avenue ElHadra
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt Lecturer of anaesthesia and pain management Medical Research Institute University of Alexandria
Role Name Email Phone Street address
Scientific Enquiries Hatem Abo Elwafa hatem_wafa@hotmail.com 00201155497711 ElHorreya Avenue ElHadra
City Postal code Country Position/Affiliation
Alexandria 21523 Egypt Lecturer of anaesthesia and pain management Medical Research Institute University of Alexandria
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
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 e-mail to elsayedamr@yahoo.com (public relation) 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