CTRI Number |
CTRI/2012/09/003011 [Registered on: 24/09/2012] Trial Registered Retrospectively |
Last Modified On: |
17/06/2014 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
Comparison of use of three different laryngoscopes in children |
Scientific Title of Study
|
A randomised trial to compare Truview PCD, C-MAC and Macintosh laryngoscopes in paediatric airway management |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
IEC-89 dated 6.2.12 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Nishant Kumar |
Designation |
Assistant Professor |
Affiliation |
Lady Hardinge Medical College and Assoc. Hospitals |
Address |
Shaheed Bhagat Singh Marg, New Delhi
Central DELHI 110001 India |
Phone |
|
Fax |
|
Email |
kumarnishant@yahoo.co.uk |
|
Details of Contact Person Scientific Query
|
Name |
Dr Nishant Kumar |
Designation |
Assistant Professor |
Affiliation |
Lady Hardinge Medical College and Assoc. Hospitals |
Address |
Shaheed Bhagat Singh Marg, New Delhi
Central DELHI 110001 India |
Phone |
|
Fax |
|
Email |
kumarnishant@yahoo.co.uk |
|
Details of Contact Person Public Query
|
Name |
Dr Nishant Kumar |
Designation |
Assistant Professor |
Affiliation |
Lady Hardinge Medical College and Assoc. Hospitals |
Address |
Shaheed Bhagat Singh Marg, New Delhi
Central DELHI 110001 India |
Phone |
|
Fax |
|
Email |
kumarnishant@yahoo.co.uk |
|
Source of Monetary or Material Support
|
The Truview Picture Capture Device (PCD) will be provided by Truphatek, Mumbai, India for the purpose of the study.
The C-MAC paediatric blade will be provided by Karl Storz Endoscopy, New Delhi, India for the purpose of this study.
|
|
Primary Sponsor
|
Name |
Lady Hardinge Medical College and ASSOC HOSPITALS |
Address |
Shaheed Bhagat Singh Marg New Delhi |
Type of Sponsor |
Government 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 |
Dr Nishant Kumar |
Main operating theatres |
SSKH & KSCH, Shaheed Bhagat Singh Marg Central DELHI |
9811934659
kumarnishant@yahoo.co.uk |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Lady Hardinge Medical College & Associated Hospitals |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Paeditric patients posted for elective surgery requiring general anaesthesia with endotracheal intubation, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
C MAC laryngsocope |
It is a new videolaryngoscope which gives an indirect view of the vocal cords and previous literature has shown it to be better than the standard macintosh laryngoscope. |
Comparator Agent |
Macintosh laryngoscope |
It is the standard laryngoscope used for laryngoscopy and endotracheal intubation in all age groups |
Intervention |
Truview PCD Laryngoscope |
It is a new videolaryngoscope which gives an indirect view of the vocal cords and previous literature has shown it to be better than the standard macintosh laryngoscope. |
|
Inclusion Criteria
|
Age From |
1.00 Year(s) |
Age To |
6.00 Year(s) |
Gender |
Both |
Details |
1-6 yrs
either sex
elective surgery
requiring general anaesthesia with endotracheal intubation |
|
ExclusionCriteria |
Details |
ASA physical grade 2,
presence of raised intracranial pressure,
high risk for pulmonary aspiration of gastric contents,
coagulopathy
presence of any pathology of head and neck |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Best laryngeal view obtained (POGO score) |
At the time of laryngoscopy |
|
Secondary Outcome
|
Outcome |
TimePoints |
Time taken to intubate
No. of attempts at intubation
No. of failed intubations
No. of episodes of desaturation
Trauma caused
Need for external laryngeal maneuver |
During intubation and after that |
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/03/2012 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Prediction of difficult airway is not always possible in a child as measurement of mentohyoid, thyromental, mandibular and inter-incisor lengths have no value. A plethora of airway devices have thus flooded the market to overcome the inadequacy of difficult airway prediction. The videolaryngoscopes have provided a better view of the glottis than the conventional laryngoscopes in adults, however there is limited knowledge of their performance in paediatric patients. We have therefore designed this study to evaluate and compare the Truview PCD and C-MAC laryngoscopes to the standard Macintosh laryngoscope in paediatric patients. |