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CTRI Number  CTRI/2020/01/022942 [Registered on: 27/01/2020] Trial Registered Prospectively
Last Modified On: 17/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [using of a pillow for intubation]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to assess ease of intubation with or without intubation pillow in paediatric age group. 
Scientific Title of Study   A randomized controlled trial comparing laryngoscopy grade with or without intubation pillow in the paediatric population. 
Trial Acronym  PIP study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sonya Susan George 
Designation  Post Graduate 
Affiliation  CHRISTIAN MEDICAL COLLEGE VELLORE 
Address  Department Of Anaesthesia, Christian Medical College ,CMC Vellore, Tamil Nadu.

Chennai
TAMIL NADU
632002
India 
Phone  7868062130  
Fax    
Email  sonyasusangeorge14@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sajan Philip George 
Designation  Consultant 
Affiliation  CHRISTIAN MEDICAL COLLEGE VELLORE 
Address  Department Of Anaesthesia, Christian Medical College ,CMC Vellore, Tamil Nadu.
Department Of Anaesthesia, Christian Medical College ,CMC Vellore, Tamil Nadu.
Chennai
TAMIL NADU
632002
India 
Phone  04162282680  
Fax    
Email  sajanpg@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Sonya Susan George 
Designation  Post Graduate 
Affiliation  CHRISTIAN MEDICAL COLLEGE VELLORE 
Address  Department Of Anaesthesia, Christian Medical College ,CMC Vellore, Tamil Nadu.
Department Of Anaesthesia, Christian Medical College ,CMC Vellore, Tamil Nadu.
Chennai
TAMIL NADU
632002
India 
Phone  7868062130  
Fax    
Email  sonyasusangeorge14@rediffmail.com  
 
Source of Monetary or Material Support  
Fluid Research Grant, Christian Medical College, CMC vellore 
 
Primary Sponsor  
Name  CMC vellore 
Address  Christian Medical College, CMC Vellore, Tamil Nadu. 
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 
SONYA SUSAN GEORGE  cmc vellore ,Main Theatre complex, Peadiatric theatre- OR- 1,OR- 2, 2A, 3, 3A, ENT- OR  Christian medical college, vellore.
Chennai
TAMIL NADU 
7868062130

sonyasusangeorge14@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
cmc vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: Z428||Encounter for other plastic and reconstructive surgery following medical procedure or healed injury,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  paediatric intubation without pillow  intubating without pillow under head 
Intervention  using a pillow under the head for paediatric intubation  using pillow for intubation in paediatrics 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. All children between age group of 5 to 12 years.
2. ASA I and II
3. Normal neck movement.
 
 
ExclusionCriteria 
Details  1. No parental consent.
2. Children less than 5 years of age or more than 12-year-old.
3. ASA III or more
4. GCS less than 15
5. Limited neck extension
6. Craniofacial anomalies

 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome: Assessment of Cormack and Lehane grade of laryngoscopy  October 2020 
 
Secondary Outcome  
Outcome  TimePoints 
1. Assessment of BURP (Backwards Upwards Rightwards Pressure) maneuver to improve laryngoscopy grade.
2. Assessment of POGO score (Percentage Of Glottic Opening)

 
October 2020 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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)   01/02/2020 
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="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   planning to publish at the end of study 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The study aims to assess the role of intubation pillow versus no pillow in paediatric intubation by assessing the Cormack and Lehane Laryngoscopy grade. This will be a randomized controlled study where children between 5 to 12years of age who are undergoing elective surgery requiring endotracheal intubation, who consent for the study will be randomized into two groups. The laryngoscopy will be done using an intubation pillow in group 1 and without intubation pillow in group 2.

 

The laryngoscopy will be performed by primary investigator, an anaesthetist, who has done at least 50 paediatric intubations along with consultant who has experience in paediatric anaesthesia. The scopies will be compared and study will be started if the scopies are similar 75% of the time.

 

The child will be premedicated with syrup Trichloryl 75mg/kg one hour before the start of anaesthesia. A silicon teeth guard will be used to cover the teeth. The child will be induced in theatre with Sevoflurane (MAC intubation of 1.3), Fentanyl 1 to 2 microgram per kilogram, and atracurium 0.5 milligram per kilogram.  In children who allow an intravenous line, Propofol 1.5 to 2.5 milligram per kilogram will be used for induction of anaesthesia instead of sevoflurane. Sevoflurane will be used to maintain anaesthesia. Laryngoscopy will be done using Macintosh Blade five minutes after administration of the muscle relaxant. The primary investigator will compare Cormack and Lehane grade. For children between 5 to 9 years of age a 4 cm pillow will be used and for age group between 10 and 12, a 6cm pillow will be used.  This data will be then analyzed.  The study hypothesizes that a head elevation using the intubation pillow will facilitate a better laryngoscopy grade when compared to the traditional head neutral technique.

 
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