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
|
|
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
|
|
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.
|