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.: PACTR202210590267306 Date of Approval: 13/10/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A comparative study between C-MAC videolaryngoscope and fiberoptic laryngoscope in anticipated difficult intubation
Official scientific title A comparative study between C-MAC videolaryngoscope and fiberoptic laryngoscope in anticipated difficult intubation
Brief summary describing the background and objectives of the trial Numerous indirect laryngoscopes have been introduced into clinical practice and compared with the Macintosh laryngoscope. Most studies have described a significantly better glottic view and a higher success rate in difficult tracheal intubations for the indirect laryngoscopes. Some case reports also describe the successful use of these tools under sedation with preserved spontaneous breathing. Videolaryngoscopes with the Macintosh blades can offer the unique benefit of both direct and indirect laryngoscopy in a single intubation attempt. A typical example of such a device is C-MAC videolaryngoscope, which is the first Macintosh-type videolaryngoscope. This study will be conducted to compare between the C-MAC® D-Blade videolaryngoscope and the standard flexible fiberoptic scope in patients with anticipated difficult intubation.
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 Successful intubation of patients with anticipated difficult intubation.
Anticipated trial start date 15/10/2022
Actual trial start date
Anticipated date of last follow up 15/02/2023
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Intubation using the flexible fiberoptic scope. Before starting the operation. The patients will be intubated using the flexible fiberoptic scope. 30 Active-Treatment of Control Group
Experimental Group C MAC videolaryngoscope Before starting the operation. The patients will be intubated using the C-MAC videolaryngoscope. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age 18-60 years ASA physical status I or II El-Ganzouri risk index score ≥ 4 Primary exclusion criteria: High risk of aspiration (e.g., full stomach or gastro-esophageal reflux disease) and pregnancy Necessity of awake fiberoptic intubation or emergency surgery Expected difficult ventilation ASA physical status III or VI Cardiac and/or respiratory disease Upper airway pathology Mouth opening < 2 cm Refusal to participate Secondary exclusion criteria: Insufficient face mask ventilation and developing hypoxia (SpO2 < 95%) and/or hemodynamic instability Easy intubation (percentage of glottic opening > 0%) using direct laryngoscopy without external laryngeal manipulation Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 30/03/2022 Research Ethics Committee of the Faculty of Medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
38 Abbassia Square, Next to Al-Nour Mosque Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The time to achieve successful tracheal intubation. At the end of tracheal intubation.
Secondary Outcome Glottic view of the relaxed vocal cord. At time of intubation.
Secondary Outcome Number of intubation attempts. After tracheal intubation
Secondary Outcome Adverse events. After tracheal intubation.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospitals which is a single site for recruitment 38 Abbassia Square, Next to Al-Nour Mosque Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Heba Toulan 38 Abbassia Square, Next to Al-Nour Mosque Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Hospitals 38 Abbassia Square, Next to Al-Nour Mosque Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Heba Toulan heba.f.abdelaziz55@gmail.com +201221077317 38 Abbassia Square, Next to Al-Nour Mosque
City Postal code Country Position/Affiliation
Cairo Egypt Associate professor of Anesthesia Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Heba Toulan heba.f.abdelaziz55@gmail.com +201221077317 38 Abbassia Square, Next to Al-Nour Mosque
City Postal code Country Position/Affiliation
Cairo Egypt Associate professor of anesthesia Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Public Enquiries Mohamed Madkour m.e.s.madkour123@gmail.com +201221077317 38 Abbassia Square, Next to Al-Nour Mosque
City Postal code Country Position/Affiliation
Cairo Egypt Resident of anesthesia Faculty of Medicine Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We intend to share the de-identified individual participants data. All datasets generated and/or analyzed during the current study will be available from the corresponding author on reasonable request. This will begin 12 months and end 36 months following publication of the manuscript. Informed Consent Form,Study Protocol Starting 12 months and ending 36 months following publication of the manuscript Data will be available through direct contact with the corresponding author, to be used for systematic reviews or meta-analyses.
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