| CTRI Number |
CTRI/2024/03/064327 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
16/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To compare video laryngoscope with direct laryngoscope for intra ocular pressure response |
|
Scientific Title of Study
|
COMPARISON OF VIDEO LARYNGOSCOPE WITH DIRECT LARYNGOSCOPE FOR INTRA OCULAR PRESSURE RESPONSE TO LARYNGOSCOPY AND INTUBATION |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheetal |
| Designation |
Postgraduate resident |
| Affiliation |
Vardhman Mahavir Medical College And Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9667776174 |
| Fax |
|
| Email |
sheetal.chhillar@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepti Saigal |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College And Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
8595611255 |
| Fax |
|
| Email |
deeptisaigal21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepti Saigal |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College And Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
8595611255 |
| Fax |
|
| Email |
deeptisaigal21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College And Safdarjung Hospital, Ansari Nagar, New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College And Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College And Safdarjung Hospital, Ansari Nagar, New Delhi |
| 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 Sheetal |
Vardhman Mahavir medical college and Safdarjung Hospital |
Department of Anaesthesia and intensive care, Ansari Nagar, New Delhi
South
DELHI |
9667776174
sheetal.chhillar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical college and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: R938||Abnormal findings on diagnostic imaging of other specified body structures, (2) ICD-10 Condition: R938||Abnormal findings on diagnostic imaging of other specified body structures, (3) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intraocular pressure response to laryngocopy and intubation by using Direct Laryngoscope (Macintosh laryngoscope) |
In patients undergoing elective surgery under general anaesthesia, intubation will be done by using Macintosh Direct Laryngoscope and intraocular pressure will be measured at baseline and 1,3,5,10 minutes after intubation. Total duration will be 10 minutes. |
| Comparator Agent |
Intraocular pressure response to laryngoscopy and intubation by using Video Laryngoscope (C-MAC) |
In patients undergoing elective surgery under general anaesthesia, intubation will be done by using C-MAC Video Laryngoscope and intraocular pressure will be measured at baseline and 1,3,5,10 minutes after intubation. Total duration will be 10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Classified by the American Society of Anaesthesiology Physical Status Classification as I (ASA-I) and II (ASA-II).
2. Patients undergoing elective surgery under general anaesthesia requiring endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
1. Patients with anticipated difficult airway.
2. Known allergy to local anaesthetics.
3. Patients having history of eye infections and glaucoma.
4. Raised intraocular pressure. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the change in intraocular pressure due to laryngoscopy & intubation using Macintosh direct laryngoscope with C-MAC video laryngoscope in patients undergoing elective surgery under general anaesthesia. |
At baseline & 1,3,5 and 10 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the changes in the following parameters due to laryngoscopy & intubation using Macintosh (direct laryngoscope) with C-MAC (video laryngoscope) in patients undergoing elective surgery under general anaesthesia:
1. Heart rate (HR)
2. Blood pressure (BP)- Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Mean arterial pressure (MAP)
3. SpO2
4. Intubation time. |
At baseline & 1,3,5 & 10 minutes. |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
26/03/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective interventional randomised comparative study to compare intraocular pressure response to laryngoscopy and intubation with the use of direct laryngoscope and video laryngoscope in patients undergoing elective surgery under general anaesthesia, with the hypothesis that the use of video laryngoscope for laryngoscopy and intubation results in a lesser rise in intraocular pressure than the direct laryngoscope in patients undergoing elective surgery under general anaesthesia. Primary, Intraocular pressure will be recorded at baseline and 1,3,5,10 minutes after intubation. Secondarily, Heart rate, Blood pressure- Systolic blood pressure, Diastolic blood pressure, Mean arterial pressure, Oxygen saturation, Intubation time will be recorded at baseline and 1,3,5,10 minutes after intubation. |