| CTRI Number |
CTRI/2012/04/002562 [Registered on: 11/04/2012] Trial Registered Prospectively |
| Last Modified On: |
30/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to compare the use of three laryngoscopes McGrath and Truview and Macintosh, for intubation by new and experienced anaesthetists. |
|
Scientific Title of Study
|
A prospective, randomized clinical study to compare use of McGrath and Truview and Macintosh laryngoscopes for endotracheal intubation by novice and experienced anesthetists
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumitra Bakshi |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
1102, Gloriosa,
Prin N.M.Kale Marg,
Agar Bazar, Mumbai
Dept of Anaesthesiology, Critical Care and Pain,
Tata Memorial hospital
Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400028
India |
| Phone |
9869334449 |
| Fax |
|
| Email |
sumitrabakshi@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinayak Vanjari |
| Designation |
P.G.Student |
| Affiliation |
Tata Memorial Hospital |
| Address |
B 3 Kohir chs,
Patel Estate,
Jogeshwari west,
Mumbai
Dept of Anaesthesiology, Critical Care and Pain,
Tata Memorial hospital
Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400102
India |
| Phone |
9821520950 |
| Fax |
|
| Email |
vinayakvanjari@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumitra Bakshi |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
1102, Gloriosa,
Prin N.M.Kale Marg,
Agar Bazar, Mumbai
Dept of Anaesthesiology, Critical Care and Pain,
Tata Memorial hospital
Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400028
India |
| Phone |
9869334449 |
| Fax |
|
| Email |
sumitrabakshi@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Dept of Anesthesia, Critical Care and Pain
Tata Memorial Hospital
Mumbai |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesia Tata Memorial Hospital |
| Address |
Borges Road,
Parel, Mumbai 400012
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr JV Divatia |
Professor and HOD,
Dept of Anaesthesiology, Critical Care and Pain,
Tata Memorial hospital
Parel, Mumbai 400012
|
| Dr V Vanjari |
P.G.Student
Dept of Anaesthesiology, Critical Care and Pain,
Tata Memorial hospital
Parel, Mumbai 400012
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Bakshi |
OT complex |
Second floor ,Main Building,
Tata Memorial Hospital,Borges Road,
Parel,
Mumbai
Mumbai
MAHARASHTRA |
919869334449
sumitrabakshi@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB, Tata Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients planned for elective surgery at Tata Memorial hospital and meeting the inclusion criteria. , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Macintosh Blade |
The intubation time to be compared |
| Comparator Agent |
McGrath Blade |
The intubation time with different laryngoscope blades to be compared |
| Intervention |
No new intervention to be done as part of study- intubation is the only intervention and is part of anesthesia plan. |
As part of routine anesthetic, patient would undergo laryngoscopy and intubation |
| Comparator Agent |
Truview larngoscope |
The intubation time to be compared |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Informed consent agreed upon
ASA physical status I to II patients,
Aged 18 years or older,
Scheduled to undergo elective surgical procedures requiring general anesthesia and tracheal intubation
|
|
| ExclusionCriteria |
| Details |
Refusal to consent
ASA physical status III and above
A history of difficult airway
Anticipated difficult airway on clinical examination (includes MPC I-II, Thyromental distance less than 6.5cm, Sternomental distance less than 12.5cms, interincisor gap of less than 3 cms.)
The presence of indications for rapid sequence induction of anesthesia
Patients with BMI over 30
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean time to intubate for McGrath and Truview laryngoscopes with Macintosh laryngoscope for endotracheal intubation by novice and experienced anesthetists |
The duration of the intubation attempt is defined as the time elapsed from insertion of the blade between the dental arches and the first upward deflection on the capnograph. This will be noted in seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The rate of successful placement of endotracheal tube, the number of optimization maneuvers and airway aids required to perform tracheal intubation and the incidence of trauma (broken teeth, , bleeding from gums or lips), the ease of use of the laryngoscope on a numerical rating scale (NRS) between the groups. |
Rate of successful intubation will be taken as percentage
The incidence of complication i.e. sore throat injury will be entered as categorical data. The incidence will ne recorded on the morning following surgery |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2012 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
44. Bakshi SG, Vanjari VS, Divatia JV. A prospective, randomized, clinical study to compare the use of McGrath, Truview and MacIntosh laryngoscopes for endotracheal intubation by novice and experienced Anaesthesiologists. Indian J Anaesth 2015; 59: 421-7. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This study is a Randomized, parallel group, active controlled, prospective multiple arm trail comparing use of McGrath and Truview and Macintosh laryngoscopes for endotracheal intubation by novice and experienced anesthetists that will be conducted at a single center in India. The primary outcome measures will be mean time to intubate for McGrath and Truview and Macintosh laryngoscopes. The secondary outcomes will the rate of successful placement of endotracheal tube, the number of optimization maneuvers and airway aids required to perform tracheal intubation and the incidence of trauma (broken teeth, bleeding from gums or lips), the ease of use of the laryngoscope on a numerical rating scale (NRS) between the groups. |