CTRI Number |
CTRI/2018/03/012686 [Registered on: 20/03/2018] Trial Registered Prospectively |
Last Modified On: |
21/08/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
To compare intubation of trachea with different blades of CMAC in children |
Scientific Title of Study
|
Comparison of time to intubate and intubation conditions with CMAC Miller blade size 1 and CMAC Macintosh blade size 2 in paediatric patients - A prospective randomized controlled study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Renu Sinha |
Designation |
Professor |
Affiliation |
All India Institute Of Medical Sciences |
Address |
Room No. 376, R.P Centre, AIIMS, New Delhi.
New Delhi DELHI 110029 India |
Phone |
9810305156 |
Fax |
|
Email |
renusinhaagarwal@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Renu Sinha |
Designation |
Professor |
Affiliation |
All India Institute Of Medical Sciences |
Address |
Room No. 376, R.P Centre, AIIMS, New Delhi.
New Delhi DELHI 110029 India |
Phone |
9810305156 |
Fax |
|
Email |
renusinhaagarwal@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Suryatheja |
Designation |
Junior Resident |
Affiliation |
All India Institute Of Medical Sciences |
Address |
Anaesthesiology,
AIIMS,
New Delhi.
New Delhi DELHI 110029 India |
Phone |
9182927662 |
Fax |
|
Email |
suryathejadr20@gmail.com |
|
Source of Monetary or Material Support
|
RP Centre, AIIMS, New Delhi, Ansari Nagar. |
|
Primary Sponsor
|
Name |
RP Centre All India Institute of Medical Sciences |
Address |
AIIMS, New Delhi, 110029. |
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 Renu Sinha |
RP Centre |
AIIMS
Ansari Nagar
New Delhi
110029 New Delhi DELHI |
9810305156
renusinhaagarwal@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute Ethics Committee For Postgraduate Research, All India Institute Of Medical Sciences, Ansari Nagar. |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, Posted for surgery requiring general anaesthesia, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Intubation with Miller blade size 1 and Macintosh blade size 2 |
To compare time to intubate and intubation conditions with Miller blade size 1 and Macintosh blade size 2 |
|
Inclusion Criteria
|
Age From |
1.00 Year(s) |
Age To |
4.00 Year(s) |
Gender |
Both |
Details |
.Age of 1-4 years old
.ASA 1 and 2 physical status
.Those posted for surgery requiring general anaesthesia |
|
ExclusionCriteria |
Details |
.Patients with anticipated difficult intubation
.Parental refusal to participate in the study |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To evaluate time for endotracheal intubation with the use of CMAC Miller blade size 1 and CMAC Macintosh blade size 2 |
The time taken from passing of blade through lips till removal of blade |
|
Secondary Outcome
|
Outcome |
TimePoints |
.Time to obtain best glottic view
.Ease of laryngoscopic blade insertion
.Ease of Intubation
.Incidence of complications (Desaturation, Bradycardia, injury to oral tissue) |
The time taken from passing of blade through lips till removal of blade |
|
Target Sample Size
Modification(s)
|
Total Sample Size="160" Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "160"
Final Enrollment numbers achieved (India)="160" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/04/2018 |
Date of Study Completion (India) |
18/07/2019 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
18/07/2019 |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
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
Modification(s)
|
This prospective, randomized controlled study will be conducted after approval by the institute ethics committee. A written, informed consent would be obtained from the child’s relative. The selected patients will undergo routine pre anaesthesia checkup. After shifting the child to operating room, standard ASA monitors will be connected like ECG, pulse oximeter and non-invasive BP monitoring and baseline vitals will be checked.Then child will be randomized to be included in any of the two groups (group A or group B). If patient will have intravenous cannula in situ then induction of anaesthesia will be done will propofol 2mg/kg. If patient will be not having IV cannula in situ then induction of anaesthesia will be done with 8% Sevoflurane in 100% O2, after induction of anaesthesia, IV cannula will be inserted. Then IV Fentanyl 1-2 mcg/kg and muscle relaxant Atracurium 0.5 mg/kg will be administered and lung will be ventilated for 3minutes. Laryngoscopy will be done with either CMAC Miller size1 blade [GROUP-A] or CMAC Macintosh size 2 blade[GROUP-B]. Both the blades will be inserted along the right angle of the mouth and pushing the tongue towards left side keeping the blade in the midline. Tip of the blades will be placed in vallecula with upwards force to lift the epiglottis to achieve the best glottis view. After achieving best glotticview,appropriate sized styletted endotracheal tube (ETT) will inserted through the glottis and blade will be removed. Airway maneuvers like external laryngeal manipulation or neck flexion or extension will be allowed incase of difficulty in glottis view and/or intubation. During this procedure the time variables like time for obtaining best glottic view,time for intubation and time for the procedure are measured by another individual. Appropriate position of ETT will be confirmed by checking bilateral equal air entry on auscultation. After successful intubation, close circuit will be connected and controlled ventilation will be initiated. Rest of the anaesthesia maintenance will be done according to anaesthetist’s choice. Reversal will be done by Neostigmine(50mcg/kg) and Glycopyrrolate(10mcg/kg). |