| CTRI Number |
CTRI/2022/01/039140 [Registered on: 04/01/2022] Trial Registered Prospectively |
| Last Modified On: |
25/12/2021 |
| 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
|
A study to evaluate video laryngoscopy guided intubation in patients with simulated immobilized cervical spine using Airtraq and McGrath laryngoscope. |
|
Scientific Title of Study
|
A study to evaluate video laryngoscopy guided intubation in patients with simulated immobilized cervical spine using Airtraq and McGrath laryngoscope. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prashant Kumar |
| Designation |
Professor |
| Affiliation |
PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care,
Pt. B. D .Sharma PGIMS,
Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
|
| Fax |
|
| Email |
pk.pgims@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepak Dahiya |
| Designation |
Post Graduate Student |
| Affiliation |
Department of Anaesthesia, PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care,
Pt. B. D .Sharma PGIMS,
Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
09711474071 |
| Fax |
|
| Email |
deepakdahiya83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepak Dahiya |
| Designation |
PG Student |
| Affiliation |
Department of Anaesthesia, PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care,
Pt. B. D .Sharma PGIMS,
Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
09711474071 |
| Fax |
|
| Email |
deepakdahiya83@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia and Critical Care,Post Graduate Institute of Medical Sciences,
Pandit BD Sharma University of Health Sciences, Rohtak, Haryana-124001 |
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care,
Pt. B. D .Sharma PGIMS,
Rohtak, Haryana |
| 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 Deepak Dahiya |
PGIMS, Pandit BD Sharma University of Health Sciences |
Department of Anaesthesiology & Critical Care,
Pt. B. D .Sharma PGIMS,
Rohtak, Haryana
Rohtak
HARYANA |
9711474071
deepakdahiya83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee, Pt. B.D. Sharma Institute of Research 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 |
Video laryngoscopy guided intubation in patients with simulated immobilized cervical spine using Airtraq laryngoscope |
Indirect video laryngoscopy is a well-established technique for securing airway for endotracheal intubation. Airtraq laryngoscope is a modified laryngoscopes for securing airway in patients with simulated immobilized cervical spine. |
| Comparator Agent |
Video laryngoscopy guided intubation in patients with simulated immobilized cervical spine using McGrath videolaryngoscope |
Indirect video laryngoscopy is a well-established technique for securing airway for endotracheal intubation. McGrath laryngoscope is a modified laryngoscopes for securing airway in patients with simulated immobilized cervical spine. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 to 3 physical status. |
|
| ExclusionCriteria |
| Details |
1.Patients having anticipated difficult intubation
2. Full stomach patients requiring rapid sequence intubation
3. BMI > 35 Kg/m2
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ease of Intubation assessed by Intubation Difficulty Score (IDS) |
At time of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Success rate in first attempt
2.Time taken for intubation
3.POGO score
4.Hemodynamic variation
5.Complications if any.
|
at 0 minutes, 1 minute , 3 minutes and 5 minutes after intubation |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
14/01/2022 |
| 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="1"
Months="0"
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)?
Response - NO
|
|
Brief Summary
|
This prospective, randomized, single blind study will
be conducted in the Department of Anesthesiology and Critical care, Pt. B. D.
Sharma PGIMS, Rohtak. Fifty
patients of either sex aged between 20-60 years belonging to American Society
of Anesthesiologists (ASA) I-III physical status, undergoing surgical procedure
requiring intubation will be included in this study. All
the patients will be examined preoperatively and details of clinical history,
general physical examination and systemic examination will be recorded.
Detailed examination of the patients will be carried out for any neck mass,
cervical spine mobility & any loose teeth if present on physical
examination of the patient. Routine investigations like hemoglobin, bleeding
time, clotting time and urine routine examination will be done in all the
patients. Other investigations such as blood urea, blood sugar, serum
electrolytes, chest X-ray, Electrocardiogram (ECG) and any other specific
investigation will be carried out if required. Patient will be explained about
the procedure and written informed consent will be obtained for participation
in the study.
|