| CTRI Number |
CTRI/2021/06/034071 [Registered on: 08/06/2021] Trial Registered Prospectively |
| Last Modified On: |
06/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Randomized Comparative Clinical Trial |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of VIDEOLARYNGOSCOPE with 2.4 Inches Screen V/S VIDEOLARYNGOSCOPE with 24 Inches Screen on Interfacial Distance. |
|
Scientific Title of Study
|
COMPARATIVE OBSERVATION OF VIDEOLARYNGOSCOPE HAVING 2.4 INCHES SCREEN VS VIDEOLARYNGOSCOPE CONNECTED TO 24 INCHES SCREEN ON INTER-FACIAL DISTANCE AT THE TIME OF ENDOTRACHEAL INTUBATION-A RANDOMIZED CONTROL TRIAL. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Kumar |
| Designation |
Post Diploma DNB Trainee |
| Affiliation |
Northern Railway Central Hospital, New Delhi |
| Address |
Department of Anesthesiology, Ward-4, Northern Railway Central Hospital, Basant Lane, New Delhi
South
DELHI
110024
India |
| Phone |
9717630521 |
| Fax |
|
| Email |
rakeshkmr369b@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AK Sharma |
| Designation |
Chief Anaesthesiologist |
| Affiliation |
Northern Railway Central Hospital, New Delhi |
| Address |
Department of Anaesthesiology, Northern Railway Central Hospital, Basant Lane, New Delhi
Central
DELHI
110055
India |
| Phone |
9717630508 |
| Fax |
|
| Email |
dr_aksharma@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr AK Sharma |
| Designation |
Chief Anaesthesiologist |
| Affiliation |
Northern Railway Central Hospital, New Delhi |
| Address |
Department of Anaesthesiology, Northern Railway Central Hospital, Basant Lane, New Delhi
Central
DELHI
110055
India |
| Phone |
9717630508 |
| Fax |
|
| Email |
dr_aksharma@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Northern Railway Central Hospital |
|
|
Primary Sponsor
|
| Name |
Northern Railway Central Hospital |
| Address |
Northern Railway Central Hospital, Basant Lane, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakesh Kumar |
Northern Railway Central Hospital |
Operation Theatre, First Floor, Northern Railway Central Hospital, Basant Lane, New Delhi
Central
DELHI |
9717630521
rakeshkmr369b@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Northern Railway Central Hospital, IEC-NRCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
VIDEOLARYNGOSCOPE Connected To 2.4 Inches Screen. |
Endotracheal Intubation using 2.4 Inches Screen VIDEOLARYNGOSCOPE |
| Comparator Agent |
VIDEOLARYNGOSCOPE Connected To 24 Inches Screen. |
Endotracheal Intubation using 24 Inches Screen VIDEOLARYNGOSCOPE. |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients Having Age Between 20-70 Years.
2. Patients Belonging to American Society of Anaesthesiologists physical status I/II/III.
3. Patients Planned to undergo surgery under General Anaesthesia (Elective Surgical Procedures) with Tracheal Intubation.
4. Patients Having Mallampati Grade 1/2/3. |
|
| ExclusionCriteria |
| Details |
1. Patients who underwent General Anaesthesia (G.A) in the past seven days.
2. Patients with American Society of Anaesthesiologists physical status IV.
3. Obese Patients with B.M.I More than 35Kg/Meter Sq.
4. Pregnant Patients
5. Emergency Operations
6. Patients Not Able to give consent.
7. Patients having unstable Cervical Spine
8. Patients who are suspected/Confirmed cases of COVID-19. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare the Interfacial Distance between Patients AND Anaesthesiologists at the time of Endotracheal Intubation while using VIDEOLARYNGOSCOPE having 2.4 Inches Screen V/S VIDEOLARYNGOSCOPE Connected to 24 Inches Screen. |
At the time of Endotracheal Intubation. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
To Know the ease of intubation with both techniques in terms of
1. Success Rate (Success rate will be defined as no. of successful E.T Intubation divided by total number of intubation and multiplied by 100).
2. Intubation Attempts (Insertion of VIDEOLARYNGOSCOPE into mouth and its removal will be considered as an attempt.)
3. Time Taken For Intubation.
4. Vocal Cord Visualization (Cormack Lehane Grading) |
At the time of Endotracheal Intubation. |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/07/2021 |
| 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="0"
Months="6"
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
|
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Brief Summary
|
Endotracheal intubation is a lifesaving procedure. It is done when patient is critically ill and also at the time of General Anaesthesia before surgery. Endotracheal intubation is a potentially Aerosol generating procedure. Endotracheal Intubation is a risky procedure and carry a risk of transmission of diseases to the health care provider. Risk of infection transmission can be reduced if distance between patient and Intubator is more. VIDEOLARYNGOSCOPE is helpful in this regard as distance between Intubator and patient is more with VIDEOLARYNGOSCOPE in comparison to conventional Laryngoscope. In our observation trial study, we are comparing VIDEOLARYNGOSCOPE having 2.4 inches screen and VIDEOLARYNGOSCOPE connected to 24 inches screen and want to know whether there is any difference in interfacial distance at the time of ET intubation while using VIDEOLARYNGOSCOPE having 2.4 inches screen Vs VIDEOLARYNGOSCOPE connected to 24 inches screen.
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