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CTRI Number  CTRI/2019/01/016886 [Registered on: 03/01/2019] Trial Registered Prospectively
Last Modified On: 02/01/2019
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 tracheal intubation with two video laryngoscopes after anesthesia induction in infants 
Scientific Title of Study   COMPARATIVE EFFICACY OF CMAC MILLER VIDEOLARYNGOSCOPE Versus McGRATH MAC VIDEOLARYNGOSCOPE IN INFANTS UNDERGOING SURGICAL PROCEDURES 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pooja Singh 
Designation  Post graduate student 
Affiliation  VMMC and Safdarjung Hospital 
Address  Department of Anesthesiology and Intensive care, VMMC and Safdarjung Hospital

South
DELHI
110029
India 
Phone    
Fax    
Email  shaku.nip5588@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anju Gupta 
Designation  Assistant Professor 
Affiliation  VMMC and Safdarjung Hospital 
Address  Department of Anesthesiology and Intensive care, VMMC and Safdarjung Hospital

South
DELHI
110029
India 
Phone  9911573371  
Fax    
Email  dranjugupta2009@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  K K Girdhar 
Designation  Consultant and Professor 
Affiliation  VMMC and Safdarjung Hospital 
Address  Department of Anesthesiology and Intensive care, VMMC and Safdarjung Hospital

South
DELHI
110029
India 
Phone    
Fax    
Email  drkkgirdhar@gmail.com  
 
Source of Monetary or Material Support  
Departmental of Anesthesia and Intensive care, VMMC and Safdarjung Hospital, New Delhi 
 
Primary Sponsor  
Name  Department of Anesthesiology and Intensive Care 
Address  VMMC and Safdarjung Hospital 
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 
Anju Gupta  VMMC and Safdarjung hospital  OT Complex, second floor, New Emergency Block, Department of Anesthesiology and Intensive Care
South
DELHI 
9911573371

dranjugupta2009@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, VMMC and Safdarjung Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CMAC Group  Intubation with CMac Videolaryngosocpe (Miller Blade)  
Intervention  McGrath Group  Intubation with McGrath Videolaryngosocpe 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  12.00 Month(s)
Gender  Both 
Details  American Society of Anaesthesiologists (ASA) grade I- III. 
 
ExclusionCriteria 
Details  Anticipated difficult airway or any such history
Congenital anomalies of head and neck
History of birth asphyxia
Coagulation defect
Any child with increased risk of aspiration 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Total intubation time   after intubation 
 
Secondary Outcome  
Outcome  TimePoints 
Time to glottic view, tube insertion time, ETCO2 at the end of intubation, lowest SpO2 saturation reading during the intubation, POGO score and Modified Cormack-Lehane score, intubation difficulty scores & need for optimizing manoeuvres [OELM/ head extension], successful intubation at first attempt and total number of attempts, hemodynamic parameters, complications desaturation (SPO2 95%), trauma (lip, gum, airway), mucosal bleed or esophageal intubation.
 
one time  
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/01/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Airway management is integral part of general anaesthesia. Videolaryngoscopy (VL) is a new technique that has the potential to facilitate endotracheal intubation and decrease adverse consequences. In adult population the advantages of VL over direct laryngoscopy (DL) have already been proven in several studies conducted in patients with normal and difficult airways and critically ill patient. In comparison to adults, intubation in infant and neonates is more challenging due to various anatomical and physiological factors. Pediatric tracheal intubations (TI) may require multiple attempts, especially in neonates and infants and those with a history of difficult airway and craniofacial anomalies. But, each additional attempt is associated with increased chances of desaturation and airway morbidity.

VL facilitates tracheal intubation during simulated/ clinically difficult intubation in adults, but it is not clear whether these findings translate to children.  Comprehensive clinical studies about the efficacy of paediatric VL for routine practice in difficult airways in children are inadequate and poorly documented. Well-designed, adequately powered randomized controlled studies are necessary to address efficacy and safety of VL for endotracheal intubation in neonates.

CMAC VL has compared favorably to the conventional DL for intubation in infants and children. Recently, McGrath MAC blade size 1 VL has been launched which is similar to conventional Macintosh blade. There is paucity of studies comparing CMAC Miller blade VL with McGrath MAC blade VL in respect to their clinical efficacy in infants. So, we aim to establish whether the novel McGrath MAC videolaryngoscope provides equivalent performance as compared to CMAC Miller videolaryngoscope with respect to time to intubation in infants. We will recruit a total of 140 neonates and infants as per our inclusion and exclusion criteria as mentioned above. After standard General anesthesia they will be intubated as per their group allocation. the observations will be recorded as mentioned above.

 
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