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CTRI Number  CTRI/2021/06/034018 [Registered on: 07/06/2021] Trial Registered Prospectively
Last Modified On: 11/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A randomised study to compare two techniques for ease of insertion of artificial ventilation tube in children undergoing surgeries under general anaesthesia 
Scientific Title of Study   A RANDOMISED STUDY TO COMPARE C-MAC D BLADE VIDEOLARYNGOSCOPE WITH McCOY DIRECT LARYNGOSCOPE FOR INTUBATION IN CHILDREN UNDERGOING SURGERIES UNDER 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 Geeta Kamal 
Designation  Head of Department and Specialist 
Affiliation  Chacha Nehru Bal Chikitsalaya 
Address  Department of Anaesthesia Chacha Nehru Bal Chikitsalaya Geeta Colony New Delhi
Chacha Nehru Bal Chikitsalaya Geeta Colony New Delhi 110031
East
DELHI
110031
India 
Phone  9643308229  
Fax    
Email  kmlgeeta@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Divyamedha Agarwal 
Designation  Fellow in pediatric anaesthesia 
Affiliation  Chacha Nehru Bal Chikitsalaya 
Address  Department of Anaesthesia Chacha Nehru Bal Chikitsalaya Geeta Colony New Delhi 110031

East
DELHI
110031
India 
Phone  9779587651  
Fax    
Email  divyamedha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Divyamedha Agarwal 
Designation  Fellow in pediatric anaesthesia 
Affiliation  Chacha Nehru Bal Chikitsalaya 
Address  Department of Anaesthesia Chacha Nehru Bal Chikitsalaya Geeta Colony New Delhi 110031

East
DELHI
110031
India 
Phone  9779587651  
Fax    
Email  divyamedha@gmail.com  
 
Source of Monetary or Material Support  
Chacha Nehru Bal Chikitsalaya 
 
Primary Sponsor  
Name  Chacha Nehru Bal Chikitsalaya 
Address  Geeta Colony, New Delhi - 110031 
Type of Sponsor  Research institution and hospital 
 
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 
Divyamedha Agarwal  Department of Anaesthesia, OT complex, 2nd floor  Chacha Nehru Bal Chikitsalaya Geeta Colony
East
DELHI 		 9779587651

divyamedha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee chacha nehru bal chikitsalaya  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  C-MAC D BLADE VIDEOLARYNGOSCOPE  The device will be used for intubating children undergoing surgeries under general anaesthesia which takes upto 40 - 50 seconds maximum 
Comparator Agent  McCOY DIRECT LARYNGOSCOPE  The device will be used for intubating children undergoing surgeries under general anaesthesia which takes upto 40 - 50 seconds maximum 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  ASA class 1 and 2 
 
ExclusionCriteria 
Details  1. Patients with anticipated difficult airway
2. Children with known metabolic disease
3. Children having reactive airway disease
4. Known case of Mental retardation or developmental delay
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Intubation Difficulty Score  0 min 
 
Secondary Outcome  
Outcome  TimePoints 
1. Modified Cormack and Lehane grading  0 minute at the time of laryngoscopy 
2. Time to best glottic view   0 minute 
3. Time to intubate  0 minute just after intubation 
4. Total duration of procedure of intubation  0 minute 
5. Hemodynamic measurements (Heart rate, systolic BP, diastolic BP, mean arterial BP and SpO2 will be recorded at baseline and at 1st min, 3rd min, 5th min and 10th min of intubation.)  Baseline,1minute, 3rd minute, 5th minute and 10th minute after intubation 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/06/2021 
Date of Study Completion (India) 18/10/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Submitted for publication  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

INTRODUCTION: Pediatric airway is not a miniature replica of adult airway and presents unique challenges to anaesthesiologist. C-MAC and McCoy laryngoscopes have been well validated for routine and difficult airway in adult patients, but there is limited data available for their efficacy in pediatric airway management. Hence, we propose this study to compare the performance of C-MAC videolaryngoscope with PEDD blade and McCoy laryngoscope in pediatric airway management.

AIM OF THE STUDY: To compare the C-MAC D blade videolaryngoscope with McCoy direct laryngoscope for intubation in children.

OBJECTIVES

 PRIMARY OBJECTIVES

  1. To compare the ease of intubation (Intubation Difficulty Scale)

SECONDARY OBJECTIVES

1. To compare visualisation of glottic inlet (Modified Cormack and Lehane grading)

2.     To compare the duration of laryngoscopy 

3.      To compare the duration of intubation

To To compare the duration of process of intubation

4.     To compare hemodynamic responses

MATERIAL AND METHODS

•Study Design: Prospective, Randomized Study

• Study Period: March 2021 to October 2021

•Place of study: Department of Anaesthesia, Chacha Nehru Bal Chikitsalya, New Delhi

·       Inclusion criteria:

1.     Patients aged between 4 – 12 years

2.     ASA 1 and ASA 2 patients 

3.     Patients undergoing elective surgery requiring general anaesthesia and endotracheal intubation

·       Exclusion criteria

1.     Patients with anticipated difficult airway

2.     Children having severe cardiac or respiratory disease

3.     Children with metabolic disease

4.     Children having reactive airway disease

5.     Children having mental retardation or developmental delay

Outcome Measures:

Primary Outcomes

1.     Intubation Difficulty Scale

Secondary Outcomes

1.     Modified Cormack and Lehane grading

2.     Time to best glottic view (time from insertion of laryngoscope blade between the teeth till the best possible view of vocal cords)

3.     Time to intubate (time from best glottic view till passage of ETT through vocal cords)

4.     Total duration of intubation (sum of duration of laryngoscopy and duration of intubation)

5.     Hemodynamic measurements (Heart rate, systolic BP, diastolic BP, mean arterial BP and SpO2 will be recorded at baseline and at 1st min, 3rd min, 5th min and 10th min of intubation.)

6. any incidence of airway complication.

Methodology: 70 patients of ASA physical status 1 and 2 scheduled for elective surgeries under GA with endotracheal intubation will be randomised and allocated into one of the two groups; each having 35 patients.

Statistical Tests:

Statistical analysis will be performed by the SPSS program for Windows, version 17.0(SPSS, Chicago, Illinois). Continuous variables will be presented as mean ± SD, and categorical variables will be presented as absolute numbers and percentage. Data will be checked for normality before statistical analysis. Normally distributed continuous variables will be compared using the unpaired t test, whereas the Mann-Whitney U test will be used for those variables that are not normally distributed. Categorical variables will be analyzed using either the chi square test or Fisher’s exact test. P<0.05 will be considered statistically significant.

 
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