FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/04/033279 [Registered on: 30/04/2021] Trial Registered Prospectively
Last Modified On: 25/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARISON BETWEEN C MAC VIDEO LARYNGOSCOPE AND TUOREN VIDEO LARYNGOSCOPE FOR ENDOTRACHEAL INTUBATION IN PEDIATRIC POPULATION UNDERGOING GENERAL ANAESTHESIA 
Scientific Title of Study   C MAC VIDEO LARYNGOSCOPE VERSUS TUOREN VIDEO LARYNGOSCOPE FOR ENDOTRACHEAL INTUBATION IN THE PAEDIATRIC POPULATION UNDERGOING GENERAL ANAESTHESIA  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR ASHIKA JOHNEY 
Designation  Post Graduate student, M. D. Anaesthesiology 
Affiliation  Maulana Azad Medical College and Associated Hospitals 
Address  Department of Anaesthesiology and Intensive Care, C/O Dr Sonia Wadhawan, 3rd floor, BL Taneja Block, Maulana Azad Medical College and Associated Hospitals, Bahadur Shah Zafar Marg, New Delhi 110002

Central
DELHI
110002
India 
Phone  9310138509  
Fax    
Email  ashika.johney@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SONIA WADHAWAN 
Designation  Director Professor 
Affiliation  Maulana Azad Medical College and Associated Hospitals 
Address  Department of Anaesthesiology and Intensive Care, 3rd floor, BL Taneja Block, Maulana Azad Medical College and Associated Hospitals, Bahadur Shah Zafar Marg, New Delhi 110002

Central
DELHI
110002
India 
Phone  9968604218  
Fax    
Email  soniawadhawan@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  DR ASHIKA JOHNEY 
Designation  Post Graduate student, M. D. Anaesthesiology 
Affiliation  Maulana Azad Medical College and Associated Hospitals 
Address  Department of Anaesthesiology and Intensive Care, C/O Dr Sonia Wadhawan, 3rd floor, BL Taneja Block, Maulana Azad Medical College and Associated Hospitals, Bahadur Shah Zafar Marg, New Delhi 110002

Central
DELHI
110002
India 
Phone  9310138509  
Fax    
Email  ashika.johney@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Intensive Care, Maulana Azad Medical College and Associated Hospitals, Bahadur Shah Zafar Marg, New Delhi 110002 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  Maulana Azad Medical College and Associated Hospitals, Bahadur Shah Zafar Marg, New Delhi 110002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashika Johney  Lok Nayak Hospital  OT Block, Department of Anaesthesiology and Intensive Care, Delhi Gate, Jawahar Lal Nehru Marg, New Delhi 110002
Central
DELHI 
9310138509

ashika.johney@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College and Associated Hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Laryngoscopy and Endotracheal Intubation with C Mac video laryngoscope in paediatric population undergoing general anaesthesia  Children in this group will undergo laryngoscopy and endotracheal intubation by using C Mac video laryngoscope with appropriate C Mac blade of Macintosh size 2/3, for which Intubation Difficulty Scale Score, time taken to intubate, hemodynamic response and post operative complications will be noted  
Comparator Agent  Laryngoscopy and Endotracheal Intubation with Tuoren video laryngoscope in paediatric population undergoing general anaesthesia  Children in this group will undergo laryngoscopy and endotracheal intubation by using Tuoren video laryngoscope with appropriate blade of Macintosh size 2, for which Intubation Difficulty Scale Score, time taken to intubate, hemodynamic response and post operative complications will be noted  
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Patients belonging to American Society of Anaesthesiologists (ASA) Physical Grade I and II undergoing elective surgery under general anaesthesia requiring endotracheal intubation.  
 
ExclusionCriteria 
Details  1. Patients with mouth opening less than or equal to 2.5 cm
2. Patients belonging to Modified Mallampati class III and IV
3. Patients with predicted difficult airway (anatomical deformity of head and neck, fracture of maxillofacial region or tumors of oral cavity). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Intubation Difficulty Scale (IDS) score, consisting of seven parameters  During laryngoscopy and endotracheal intubation  
 
Secondary Outcome  
Outcome  TimePoints 
Time taken to intubate  Between blade entry past the lips and the appearance of first square wave capnograph 
Intraoperative hemodynamic response measured by:
1.Heart rate trend in the intraoperative period
2. Mean arterial pressure trend during the intraoperative period 
Baseline - before induction of anaesthesia

At the time of insertion of airway device

Every 2 minutes after insertion of device for first 10 minutes 
Complications including:
1. Blood staining on the device or tracheal tube
2. Post operative sore throat  
Recovery period after surgery

24 hours postoperatively  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/05/2021 
Date of Study Completion (India) 30/06/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/06/2022 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ashika.johney@gmail.com].

  6. For how long will this data be available start date provided 31-03-2023 and end date provided 31-03-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

The pediatric airway management poses a challenge to anaesthesiologists across the globe due to the major anatomical, physiological and developmental differences in them as compared to the adult population. One of the prime causes of anaesthetic morbidity and mortality is complications arising from difficult tracheal intubation despite recent evolution in airway management strategies. Direct laryngoscopy (DL) has been regarded as the gold standard for endotracheal intubation (ETI) in both paediatric and adult patients. Direct laryngoscopy guided tracheal intubation requires the three axes (oral, pharyngeal and laryngeal) to be arranged in one straight line, achieved by placing the head and neck in the sniffing position. Up to 4.7% of paediatric patients undergoing general anaesthesia (GA) may present with difficult intubation. Hence, one has to be equipped to manage a situation of difficult airway at all times.


In an attempt to reduce the morbidity and mortality associated with difficult airway, several video laryngoscopes (VLs) such as Glidescope, Truview, Airtraq and C-MAC have been introduced into clinical practice. These video laryngoscopes ensure a better glottic view, with greater intubation success and reduced complications as compared to the conventional direct laryngoscopy in the adult population, and are being increasingly used in the paediatric population. Flexible fiberoptic bronchoscopes are used in difficult pediatric airway, but are technically more challenging than the video laryngoscopes.


 The C-MAC VL is a fourth generation VL, with a standard Miller/Macintosh blade with a distal camera at two-thirds of its length. It has been successfully used for visualization of the larynx in various difficult airway cases. It is available in the Macintosh blade sizes (sizes 2, 3, and 4) and pediatric Miller sizes (sizes 0 and 1). It also has a D- blade for difficult airways.

Tuoren is a newer video laryngoscope, which has advantages of disposable blades, large screen size, anti-fogging feature and a longer battery life, in addition to being portable and cost effective. It has a blade that has retained the shape and curvature of Macintosh blade. The reusable laryngoscope handle is fully compatible with 6 size of blades: Mac2/Mac3/Mac4/MIL00/MIL0/MIL1.

Hence, in this randomized comparative study, we aim to compare C Mac and Tuoren video laryngoscope guided endotracheal intubation using micro-cuffed endotracheal tube in paediatric patients undergoing elective surgery under general anaesthesia.

 
Close