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CTRI Number  CTRI/2016/12/007609 [Registered on: 23/12/2016] Trial Registered Prospectively
Last Modified On: 31/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   comparison of two types of laryngoscope blades for intubation under anesthesia in infants 
Scientific Title of Study   Comparative evaluation of the TruView PCD and C-MAC infant video laryngoscopes for tracheal intubation in infants with normal airways: A prospective randomized 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 Anju Gupta 
Designation  Assistant Professor 
Affiliation  Chacha Nehru Bal Chikitsalya 
Address  Departemnt of Anesthesiology, Chacha Nehru Bal Chikitsalya, Geeta Colony, New Delhi

East
DELHI
110031
India 
Phone  9643308220  
Fax    
Email  dranjugupta2009@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anju Gupta 
Designation  Assistant Professor 
Affiliation  Chacha Nehru Bal Chikitsalya 
Address  Departemnt of Anesthesiology, Chacha Nehru Bal Chikitsalya, Geeta Colony, New Delhi


DELHI
110031
India 
Phone  9643308220  
Fax    
Email  dranjugupta2009@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anju Gupta 
Designation  Assistant Professor 
Affiliation  Chacha Nehru Bal Chikitsalya 
Address  Departemnt of Anesthesiology, Chacha Nehru Bal Chikitsalya, Geeta Colony, New Delhi


DELHI
110031
India 
Phone  9643308220  
Fax    
Email  dranjugupta2009@rediffmail.com  
 
Source of Monetary or Material Support  
Chacha Nehru Bal Chikitsalya 
 
Primary Sponsor  
Name  Chacha Nehru Bal Chikitsalya 
Address  Geeta Colony, New Delhi 
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 
Dr Anju Gupta  Chacha Nehru Bal Chikitsalya  OT block second floor, Department of Anesthesia Chacha Nehru Bal Chikitsalya, Geeta Colony, New Delhi-110031
East
DELHI 
9643308220

dranjugupta2009@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAMC and GB Pant Ethics committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  60 ASA Grade – I/II infants (less than 1 year) of either sex admitted for elective surgery requiring general anesthesia and endotracheal intubation, (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group CM   intubated with the aid of CMAC laryngoscope (size 0, 1) 
Comparator Agent  Group TR  intubated by the Truview PCD (size 0, 1) 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Year(s)
Gender  Both 
Details  ASA Grade – I/II infants (less than 1 year) of either sex admitted for elective surgery requiring general anesthesia and endotracheal intubation 
 
ExclusionCriteria 
Details  Patients with an ASA physical status greater than Grade II, features suggestive of increased intracranial pressure, increased risk for pulmonary aspiration of gastric contents, known coagulopathy and any pathology of the head and neck will be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the time required for intubation with CMAC videolaryngosocpe and Truview PCD videolaryngoscope for intubation in infants   time to intubation will be recorded once 
 
Secondary Outcome  
Outcome  TimePoints 
first attempt and overall success rate, number of attempts for intubation, the glottis views using Cormack Lehane grading system
 
during intubation period 
 
Target Sample Size
Modification(s)  
Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/12/2016 
Date of Study Completion (India) 28/04/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
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
Modification(s)  
Gupta A, Kamal G, Gupta A, Sehgal N, Bhatla S, Kumar R. Comparative evaluation of CMAC and Truview picture capture device for endotracheal intubation in neonates and infants undergoing elective surgeries: A prospective randomized control trial. Paediatr Anaesth. 2018;28(12):1148‐1153. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Airway management in infants remains a challenge to anesthesiologist due to various morphological features. Videolaryngoscope are increasingly being used in this patient population. Truview PCD was the earliest videolaryngoscope introduced for pediatric patients. It has demonstrated superiority regarding airway management over conventional direct laryngoscopy. Novel C-MAC infant blade (Karl Storz GmbH & Co. KG, Tuttlingen, Germany) has a camera providing an 80° angle of view and a light source are recessed from the tip of the blade. The electronic unit sits in a handle attached to the laryngoscope blade and is connected by a wire to a portable TFT video monitor. The system allows for the Macintosh laryngoscope blade to be used for direct and indirect laryngoscopy.  C-MAC infant blade has not been prospectively compared to Truview videolaryngosocpe in the past. After institutional research committee’s approval this prospective, randomized, study will be conducted in 60 ASA Grade – I/II infants  ( 0-12months) of either sex admitted for elective surgery under general anesthesia who will be divided into two groups of 60 each:

Group CM [intubated with the aid of CMAC laryngoscope (size 0, 1)]

Group TR (intubated by the Truview PCD (size 0, 1)

 After a thorough preanesthetic checkup, adequate fasting as per the ASA guidelines, and written informed parents/guardian consent, the infants will be shifted to the operating room and routine monitors will be applied. Inhalational/ intravenous induction will be achieved as deemed appropriate. Neuromuscular blockade will facilitated by atracurium besylate bromide 0.5 mg/kg and trachea intubated after 180 seconds. Patients allocated to Group TR will be intubated with the aid of the Truview PCD and appropriate size stylet provided with Truview. In Group CM, the CMAC videolaryngosocpe with an appropriate size stylet will be used to intubate. All intubations will be performed by the anesthesiologist with more than 10 year experience with intubation in pediatric patients and a previous experience of at least 20 intubations with the Truview PCD and the C-MAC blade. The time to intubation will be measured by an independent observer using stop watch. The number of attempts was defined as withdrawing the tube to the angle of the mouth and reintroducing it. Single intubation attempt will be limited to <20seconds. Any fall in oxygen saturation to < 95% on the pulse oximeter will be noted and the lungs will be ventilated with 100% oxygen. If more than three attempts or if > 60 seconds were required after combined attempts to secure an endotracheal tube, it was considered a failed intubation. Primary endpoint in our study will be the total time required for successful intubation. The ease of intubation will be graded by the intubating anesthetist on a numerical rating scale. The data thus collected will be expressed as a number or mean ± standard deviation. Appropriate statistical tests will be applied for analysis. 

 
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