| CTRI Number |
CTRI/2018/11/016454 [Registered on: 28/11/2018] Trial Registered Prospectively |
| Last Modified On: |
25/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
a study to compare two diffrent things by applying a collar around neck |
|
Scientific Title of Study
|
A study to compare Airtraq and McCoy Laryngoscope for endotracheal intubation in patients with simulated immobilized cervical spine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prashant Kumar |
| Designation |
Professor |
| Affiliation |
PGIMS ROHTAK |
| Address |
Room No.3 Surgery opertaion theatre, Department of Anaesthesia, PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8059781684 |
| Fax |
|
| Email |
pk.pgims@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Kumar |
| Designation |
Professor |
| Affiliation |
PGIMS ROHTAK |
| Address |
H. No.17/8 FM,
Medical Campus,
PGIMS,Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416336901 |
| Fax |
|
| Email |
pk.pgims@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Pradeep Kumar Moolchandani |
| Designation |
Junior Resident |
| Affiliation |
PGIMS ROHTAK |
| Address |
Room No.3 Surgery opertaion theatre, Department of Anaesthesia, PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8059781684 |
| Fax |
|
| Email |
prdpmoolchandani@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology Pt B D Sharma PGIMS Rohtak |
| Address |
Pt. B D Sharma PGIMS Rohtak |
| 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 Prashant Kumar |
Pt. B D Sharma PGIMS Rohtak |
Surgery Operation Theatre, Room No.3,Department of Anaesthesia,Pt. B D Sharma PGIMS Rohtak
Rohtak
HARYANA |
9416336901
pk.pgims@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comapring intubation by Airtraq and McCoy laryngoscope |
Comapring intubation by Airtraq and McCoy laryngoscope by applying philadelphia cervical collar |
| Comparator Agent |
intubation after applying philadelphia cervical collar |
intubation after applying philadelphia cervical collar so that neck get immobilized |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA) I-III physical status
undergoing surgical procedure requiring intubation |
|
| ExclusionCriteria |
| Details |
Patients having anticipated difficult intubation
Full stomach patients requiring rapid sequence intubation
BMI > 35 Kg/m2 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Intubation Time
Modified Cormack and Lehane grading scale
Percentage of glottic opening score (POGO)
IDS(Intubation Difficulty Scale)
First attempt success rate
Number of attempts
Compictains |
Intubation time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| hemodynamic monitoring |
1 sec 3 sec 5 sec |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/12/2018 |
| Date of Study Completion (India) |
24/04/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
24/04/2019 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
I am conducting a study to compare Airtraq and McCoy laryngoscope for endotracheal intubation in patients with simulated immobilized cervical spine. By conducting this study we can know which laryngoscope is better for difficult intubation in patients where we cant move neck because of cervical spine injury. |