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
|
|
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
|
|
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.
|