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CTRI Number  CTRI/2018/03/012686 [Registered on: 20/03/2018] Trial Registered Prospectively
Last Modified On: 21/08/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare intubation of trachea with different blades of CMAC in children 
Scientific Title of Study   Comparison of time to intubate and intubation conditions with CMAC Miller blade size 1 and CMAC Macintosh blade size 2 in paediatric patients - A prospective randomized controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Renu Sinha 
Designation  Professor 
Affiliation  All India Institute Of Medical Sciences 
Address  Room No. 376, R.P Centre, AIIMS, New Delhi.

New Delhi
DELHI
110029
India 
Phone  9810305156  
Fax    
Email  renusinhaagarwal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Renu Sinha 
Designation  Professor 
Affiliation  All India Institute Of Medical Sciences 
Address  Room No. 376, R.P Centre, AIIMS, New Delhi.

New Delhi
DELHI
110029
India 
Phone  9810305156  
Fax    
Email  renusinhaagarwal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Suryatheja 
Designation  Junior Resident 
Affiliation  All India Institute Of Medical Sciences 
Address  Anaesthesiology, AIIMS, New Delhi.

New Delhi
DELHI
110029
India 
Phone  9182927662  
Fax    
Email  suryathejadr20@gmail.com  
 
Source of Monetary or Material Support  
RP Centre, AIIMS, New Delhi, Ansari Nagar. 
 
Primary Sponsor  
Name  RP Centre All India Institute of Medical Sciences 
Address  AIIMS, New Delhi, 110029. 
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 Renu Sinha  RP Centre  AIIMS Ansari Nagar New Delhi 110029
New Delhi
DELHI 
9810305156

renusinhaagarwal@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee For Postgraduate Research, All India Institute Of Medical Sciences, Ansari Nagar.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, Posted for surgery requiring general anaesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intubation with Miller blade size 1 and Macintosh blade size 2  To compare time to intubate and intubation conditions with Miller blade size 1 and Macintosh blade size 2 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  4.00 Year(s)
Gender  Both 
Details  .Age of 1-4 years old
.ASA 1 and 2 physical status
.Those posted for surgery requiring general anaesthesia 
 
ExclusionCriteria 
Details  .Patients with anticipated difficult intubation
.Parental refusal to participate in the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate time for endotracheal intubation with the use of CMAC Miller blade size 1 and CMAC Macintosh blade size 2  The time taken from passing of blade through lips till removal of blade 
 
Secondary Outcome  
Outcome  TimePoints 
.Time to obtain best glottic view
.Ease of laryngoscopic blade insertion
.Ease of Intubation
.Incidence of complications (Desaturation, Bradycardia, injury to oral tissue) 
The time taken from passing of blade through lips till removal of blade 
 
Target Sample Size
Modification(s)  
Total Sample Size="160"
Sample Size from India="160" 
Final Enrollment numbers achieved (Total)= "160"
Final Enrollment numbers achieved (India)="160" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2018 
Date of Study Completion (India) 18/07/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 18/07/2019 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

This prospective, randomized controlled study will be conducted after approval by the institute ethics committee. A written, informed consent would be obtained from the child’s relative. The selected patients will undergo routine pre anaesthesia checkup.                                                                                                 

After shifting the child to operating room, standard ASA monitors will be connected  like ECG, pulse oximeter and non-invasive BP monitoring and baseline vitals will be checked.Then child will be randomized to be included in any of the two groups (group A or group B). If patient will have intravenous cannula in situ then induction of anaesthesia will be done will propofol 2mg/kg. If patient will be not having IV cannula in situ then induction of anaesthesia will be done with 8% Sevoflurane in 100% O2, after induction of anaesthesia, IV cannula will be inserted. Then IV Fentanyl 1-2 mcg/kg and muscle relaxant Atracurium 0.5 mg/kg will be administered and lung will be ventilated for 3minutes. Laryngoscopy will be done with either CMAC Miller size1 blade [GROUP-A] or CMAC Macintosh size 2 blade[GROUP-B]. Both the blades will be inserted along the right angle of the mouth and pushing the tongue towards left side keeping the blade in the midline. Tip of the blades will be placed in vallecula  with upwards force to lift the epiglottis to achieve the best glottis view. After achieving best glotticview,appropriate sized styletted endotracheal tube (ETT) will inserted through the glottis and blade will be removed. Airway maneuvers like external laryngeal manipulation or neck flexion or extension will be allowed incase of difficulty in glottis view and/or intubation.                                                                                                                                                     

During this procedure the time variables like time for obtaining best glottic view,time for intubation and time for the procedure are measured by another individual.  Appropriate position of ETT will be confirmed by checking bilateral equal air entry on auscultation. After successful intubation, close circuit will be connected and controlled ventilation will be initiated. Rest of the anaesthesia maintenance will be done according to anaesthetist’s choice.                                                                                                                   

Reversal will be done by Neostigmine(50mcg/kg) and Glycopyrrolate(10mcg/kg).         

 
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