| CTRI Number |
CTRI/2019/09/021279 [Registered on: 17/09/2019] Trial Registered Prospectively |
| Last Modified On: |
01/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing which of the three different gadgets between Smarttrach, CMAC and Macintosh laryngoscopes is a better device for intubation |
|
Scientific Title of Study
|
Comparision of endotracheal intubation between Smarttrach, C-MAC and Macintosh laryngoscopes;A randomized prospective clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not Applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Kumar Kannaujia |
| Designation |
Associate Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Dept.of Anaesthesiology,
First Floor , A Block
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
05222494497 |
| Fax |
|
| Email |
ashishkannaujia77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rudrashish Haldar |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Dept.of Anaesthesiology,
First Floor , A Block
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
05222494497 |
| Fax |
|
| Email |
rudrashish@ahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Rudrashish Haldar |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Dept.of Anaesthesiology,
First Floor , A Block
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
05222494497 |
| Fax |
|
| Email |
rudrashish@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Rae Bareli Road, Lucknow,UP,226014 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Rudrashish Haldar |
SGPGIMS |
Dept. of Anaesthesiology, First Floor, A Block, Rae Bareli Road, Lucknow, Uttar Pradesh, 226014
Lucknow
UTTAR PRADESH |
9256543256
rudrashish@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, (3) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (4) ICD-10 Condition: N39||Other disorders of urinary system, (5) ICD-10 Condition: V99||Unspecified transport accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intubation qualities of three different laryngoscopes namely Smarttrach,CMAC and Mcintosh |
Comparing the intubation characteristics while using three different laryngoscope blades (Smarttrach, CMAC and Mcintosh )in terms of their success rates, time for intubation, need for external manipulation and their side effects |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II patients undergoing elective surgery |
|
| ExclusionCriteria |
| Details |
Patient refusal
Anticipated Difficult Airway ( Mallampatti Class III and IV, thyromental distance <6 cm;
and inter-incisor distance <3.5 cm)
Obesity( BMI >35)
Increased intracranial pressure or cervical spine diseases
cardiovascular disease
endocrine disease
presence of risk factors for gastric aspiration e.g. pregnancy, diabetes, etc
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary:Compare the success rates and time for intubation (i.e the time in seconds from insertion of laryngoscopes to the appearance of square wave on capnogram)
Secondary:1) CL grading, need of optimization maneuvers, no.of attempts for successful placement, haemodynamic responses, Intubation Difficulty Score (IDS) scale, subjective ease of intubation
2) Complications like injury to the lips, teeth or tongue and any blood stain on the
device
|
( the time in seconds from insertion of laryngoscopes to the appearance of square wave on capnogram)
Secondary:1) CL grading, need of optimization maneuvers, no.of attempts for successful placement, haemodynamic responses, Intubation Difficulty Score (IDS) scale, subjective ease of intubation
2) Complications like injury to the lips, teeth or tongue and any blood stain on the
device
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) CL grading, need of optimization maneuvers, no.of attempts for successful ET placement, haemodynamic responses to laryngoscopy, Intubation Difficulty Score (IDS) scale, subjective ease of intubation (VAS)
2) Complications like injury to the lips, teeth or tongue and any blood stain on the
device
|
- |
|
|
Target Sample Size
|
Total Sample Size="375"
Sample Size from India="375"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="375" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
03/10/2019 |
| Date of Study Completion (India) |
29/05/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Macintosh laryngoscopes are commonly used for endo tracheal inubation. Video laryngoscopes are commonly used nowadays like CMAC and Smarttrach. We aim to compare the intubation characteristics of these three laryngoscopes in terms of their overall success rates, number of attempts, time taken, haemodnamic changes, need for external laryngeal manipulation and complications |