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.: PACTR202408730457046 Date of Approval: 08/08/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Awake videolaryngoscopic orotracheal intubation in patients with suspected difficult intubation using the C-MAC D-Blade. Single-center experience
Official scientific title Awake videolaryngoscopic orotracheal intubation in patients with suspected difficult intubation using the C-MAC D-Blade. Single-center experience
Brief summary describing the background and objectives of the trial As videolaryngoscopes gain popularity, they gradually replace other tools as the instrument of choice for managing problematic airways. They appear to be quicker to pick up and easy to utilize.Airway assessment can be done using several techniques but considering multiple issues that are expected in such patients a multivariate score like El Ganzouri risk index assessment (EGRI) may be beneficial in providing comprehensive airway assessment for formulating appropriate intubation strategies. There has been a paradigm change in the airway management with the introduction of a variety of videolaryngeoscopes (Ababneh et al., 2023). Because videolaryngeoscope assisted awake tracheal intubation permits visualization of both the larynx and the upper airway, it is safer, quicker, and more successful.The C-MAC®VL has a hyperangulated (40°) D-blade with 1 mm thickness, an elliptical tapered half-moon shape and a facility for paraoxygenation. These features make it an attractive option in difficult intubations.This study will be conducted to evaluate the use of C-MAC VL D-blade (adult size) for awake orotracheal intubation in patients with suspected difficult intubation undergoing elective surgery under GA.
Type of trial Observational
Acronym (If the trial has an acronym then please provide) awake intubation
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 01/08/2024
Actual trial start date 30/07/2024
Anticipated date of last follow up 01/08/2024
Actual Last follow-up date 31/12/2024
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants) 179
Recruitment status Recruiting
Publication URL https://pactr.samrc.ac.za/Researcher/TrialRegister.aspx
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
Single Group Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group awake orotracheal intubation intravenous (IV) atropine 0.2 mg, dexamethasone 8 mg, ondansteron 8 mg and an IV infusion of 1mcg/kg dexmedetomidine and 1 mcg/kg fentanyl .Topical anesthesia will be applied using 5 mL of 2% lidocaine nebulized through a mouthpiece with oxygen at 8 L/minute given over 5 minutes, followed by 5 puffs of lidocaine 10% metered spray (10 mg per puff) applied directly on the mucosa of the oropharynx and fauces. over 10 min for sedation before the procedure. Preoperative anesthetic evaluation will be done 1 day prior to surgery. Airway difficulty assessment score will be recorded in all the patients (El-Ganzouri index) and fulfill inclusion criteria. In the operation room, heart rate (HR), non-invasive blood pressure (NIBP), continuous electrocardiogram and oxygen saturation (SpO2) will be recorded before the induction of anaesthesia. .The adequacy of oral and oropharyngeal topicalisation will be checked by gentle suction at the posterior pharyngeal wall before introducing the blade. A maximum dose of 5 mg/kg lidocaine will allowed to avoid toxic reactions. All patient will be in the semi-recumbent position, Preoxygenation will be done through a nasal catheter at 4 l/min. An experienced anesthesiologist will perform all awake orotracheal intubation using C-MAC VL D-blade in patients with suspected difficult intubation in Oncology Center Mansoura University (OCMU) intubations with the polyvinyl chloride tracheal tube with a soft tip (size 7-7.5) to secure the airway.   The response of the patient to introduction of the scope will be graded as follow; 0 = no coughing or gaging, 1 = mild coughing or gaging that did not hinder intubation, 2 = moderate coughing and /or gaging that interfere minimally with intubation, 3 = severe coughing and /or gaging that made intubation difficult. If severe gagging or coughing will be observed, the scope will be removed and sedation titrated upwards and a waiting period of 90 seconds will be allowed before reattempting intubation. Standard anaesthetic drugs will be used for the induction and maintenance of GA. The duration of intubation will be record (defined as the time from introduction of the scope till confirmation of correct endotracheal tube placement with three waves end tidal capnography) and the number of intubation attempts. An intubation attempt will be considered unsuccessful if the intubating device will be removed from the oral cavity due to coughing.The duration of intubation will be record (defined as the time from introduction of the scope till confirmation of correct endotracheal tube placement with three waves end tidal capnography) and the number of intubation attempts. An intubation attempt will be considered unsuccessful if the intubating device will be removed from the oral cavity due to coughing, gagging, decrease oxygen saturation or inability to view the vocal cords. After three attempts the procedure will considered a failure, the study protocol will be stopped and endotracheal intubation under inhalational induction with FOB without neuromuscular blockade (plan B) will be done and patient will be excluded from the study. 179
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients age (18 - 60 years). 2. American Society of Anesthesiologists (ASA) physical status I-III. 3. Elective surgery under GA, with anticipated difficult intubation. 4. The El-Ganzouri index, ranging from 0 to 12 points for 7 parameters and score 4 or more means suspected difficult intubation will be included. 1. Patient refusal to participate in the study. 2. The El-Ganzouri index below 4. 3. Patients age less than 18 years or more than 60 years. 4. Risk of aspiration and pregnancy. 5. Patients with complete airway obstruction, and those having airway tumors (tongue or tracheal) will also be excluded. 6. Uncooperative patients (psychotic, incapable to understanding information). 7. Contraindication to any drug used in the study. 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 23/07/2024 institutional research board
Ethics Committee Address
Street address City Postal code Country
elgomhoria Mansoura 35511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Rate of successful first attempt awake orotracheal intubation using C-MAC VL D-blade in patients with suspected difficult intubation. immediately with the intubation trial
Secondary Outcome • Number of attempts required for intubation. immediately after the intubation trial
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ONCOLOGY CENTER ELGOMHORIA STREET Mansoura 35511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
none elgomhoria st Mansoura 35511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor none elgomhoria st Mansoura 35511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ehab Mohamed ahmed mokbel elgomhoria st Mansoura 35511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dina Elebedy dinaelebedy@mans.edu.eg 0201008019744 elgomhoria st
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Lecturer of Anesthesia
Role Name Email Phone Street address
Scientific Enquiries ehab mokbel ehabmokbel@yahoo.com 201064970209 elgomhoria st
City Postal code Country Position/Affiliation
Mansoura 25511 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries hatem saber hatemsaber@mans.edu.eg 201005257062 elgomhoria st
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt professor of anesthesia
Role Name Email Phone Street address
Principal Investigator ahmed medhat dinaelebedy@mans.edu.eg 20100019744 elgomhoria st
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will be available after publishing the paper It will include the result reported in this article (text, tables, figures and appendices) and other documents like protocol,, statistical analysis, consent form will be available also, requested by email to the main investigator. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol one year following publication no end date IPD will be available for individual participant data meta-analysis IPD will be available for researchers. proposal should be directed the mail of main investigator (dinaelebedy@gmail.com) to gain access after one year of publication researchers can request data allowed from the main investigator at his mail ((dinaelebedy@gmail.com)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
dinaelebedy@gmail.com 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