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CTRI Number  CTRI/2019/10/021616 [Registered on: 14/10/2019] Trial Registered Prospectively
Last Modified On: 10/10/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing two methods of introducing a breathing tube in in children aged 1 month to 2 years 
Scientific Title of Study   A randomized comparison of C-MAC video-laryngoscope and Macintosh laryngoscope blade for tracheal intubation in childrenfrom 1-24 months 
Trial Acronym   
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Joseph Punnoose Paarel 
Designation  Assistan Professor 
Affiliation  Christian Medical College Hospital Vellore 
Address  Department Of Anaesthesia Christian Medical College Hospital VEllore Tamil Nadu

Vellore
TAMIL NADU
632004
India 
Phone  9894461330  
Fax    
Email  josephpunnoose@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Joseph Punnoose Paarel 
Designation  Assistan Professor 
Affiliation  Christian Medical College Hospital Vellore 
Address  Department Of Anaesthesia Christian Medical College Hospital Vellore Tamil Nadu

Vellore
TAMIL NADU
632004
India 
Phone  9894461330  
Fax    
Email  josephpunnoose@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Joseph Punnoose Paarel 
Designation  Assistan Professor 
Affiliation  Christian Medical College Hospital Vellore 
Address  Department Of Anaesthesia Christian Medical College Hospital Vellore Tamil Nadu

Vellore
TAMIL NADU
632004
India 
Phone  9894461330  
Fax    
Email  josephpunnoose@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia Christian Medical College Hospital Vellore Tamil Nadu India 632004 
 
Primary Sponsor  
Name  Department of Anaesthesia  
Address  Christian Medical College Hospital Vellore 
Type of Sponsor  Private 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 
Joseph Punnoose Paarel  Christian Medical College Hospital Vellore  ENT operating room/ Paediatrics operation theatre Department Of Anaesthesia CMC Hospital
Vellore
TAMIL NADU 
09894461330

josephpunnoose@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N289||Disorder of kidney and ureter, unspecified, (2) ICD-10 Condition: H619||Disorder of external ear, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  C-MAC Videolaryngoscope   Paediatric size 1 and 2 blades used during procedure of intubation 
Comparator Agent  Direct laryngoscope with Macintosh blade   Size 1 and 2 Macintosh Blade during intubation procedure 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  24.00 Month(s)
Gender  Both 
Details  Any ASA grade I and II patient aged 1 day to 1 year, presenting for elective surgery, after adequate fasting will be included in the study 
 
ExclusionCriteria 
Details  Any patient with anticipated difficult airway, full stomach, conceptual age < 60 weeks, neuromuscular diseases, history of ICU stay, syndromic child or parental refusal is excluded 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Time for visualization of the glottis
2. Time for successful intubation 
1.Time taken from introduction of laryngoscope blade into oral cavity to visualization of the glottis
2.Time taken from introduction of laryngoscope blade into oral cavity to passage of endotracheal tube past the vocal cords 
 
Secondary Outcome  
Outcome  TimePoints 
1.Incidence of trauma
2POGO score,
3.Intubation Difficulty Score 
1.Immediately after completion of intubation.
2&3. During process of intubation 
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
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)   01/11/2019 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Endotracheal intubation is considered the definitive airway for resuscitation and airway management.  The Macintosh laryngoscope is the most commonly used device, and is considered the gold standard for tracheal intubation. Over the past decade, video laryngoscopes, based on the principle of indirect laryngoscopy, have become popular as an intubating device, especially in difficult airway scenarios.

The airway of an infant differs from older children and from adults. These critical anatomical differences and the limited intubation time in infants due to higher oxygen consumption make airway related events the most common perioperative critical incidents in paediatric anaesthesia.

Several studies have shown the superiority of video laryngoscopes in adults over conventional laryngoscopes, in normal as well as difficult airway scenarios. The use of video laryngoscopes has not been extensively studied in the paediatric population. Among the few studies done in paediatric population, video laryngoscopes have been shown to provide better laryngeal views, however, time for intubation is more prolonged.

The C-MAC video laryngoscope blade design is similar to the Macintosh, with the added advantage of a video camera at the distal end of the blade. There are very few studies in children comparing C-MAC video laryngoscope with the conventional Macintosh laryngoscope.

Therefore, this randomized control study is planned with the primary objective to compare time for endotracheal intubation with C-MAC video laryngoscope and a conventional Macintosh laryngoscope.

 

 
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