| CTRI Number |
CTRI/2025/03/082575 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
Type of Study
Modification(s)
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
OPTIC NERVE SHEATH DIAMETER MEASUREMENT AS A INDICATOR FOR INTRACRANIAL PRESSURE CHANGES WITH TWO DIFFERENT INTUBATION
TECHNIQUE IN PATIENTS UNDERGOING GENERAL ANAESTHESIA |
|
Scientific Title of Study
|
A comparative study of changes in optic nerve Sheath diameter following conventional laryngoscopy VS video Laryngoscopy in patients undergoing general anesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swathi kechchawar G |
| Designation |
Assistant Professor |
| Affiliation |
karpaga Vinayaga Institute of Medical Sciences and Research Centre |
| Address |
/Room no 4, first floor, operation theatre division, anaesthesia department, karpaga Vinayaga Institute of Medical Sciences and Research Centre
Room no 4, first floor, operation theatre division, anaesthesia department, karpaga Vinayaga Institute of Medical Sciences and Research Centre
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9632431973 |
| Fax |
|
| Email |
drswathigk414@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swathi kechchawar G |
| Designation |
Assistant Professor |
| Affiliation |
Karpaga Vinayaga Institute of Medical Sciences and Research Centre |
| Address |
Room no 4, first floor, operation theatre division, anaesthesia department, karpaga Vinayaga Institute of Medical Sciences and Research
Room no 4, first floor, operation theatre division, anaesthesia department, karpaga Vinayaga Institute of Medical Sciences and Research
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9632431973 |
| Fax |
|
| Email |
drswathigk414@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swathi kechchawar G |
| Designation |
Assistant Professor |
| Affiliation |
Karpaga Vinayaga Institute of Medical Sciences and Research Centre |
| Address |
Room no 4, first floor, operation theatre division, anaesthesia department, karpaga Vinayaga Institute of Medical Sciences and Research
Room no 4, first floor, operation theatre division, anaesthesia department, karpaga Vinayaga Institute of Medical Sciences and Research
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9632431973 |
| Fax |
|
| Email |
drswathigk414@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karpaga Vinayaga Institute of Medical Sciences and Research Centre
Chengalpattu, kanchipuram district
Tamil Nadu
Pin:603308
India |
|
|
Primary Sponsor
|
| Name |
Karpaga Vinayaga Institute of Medical Sciences and Research Centre |
| Address |
Karpaga Vinayaga Institute of Medical Sciences and Research Centre PO GST road chinna kolambakkam, Chengalpattu, Tamil Nadu,India
Pin:603308 |
| 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 |
| Swathi kechchawar G |
Karpaga Vinayaga Institute of Medical Sciences and Research Centre |
Karpaga Vinayaga Institute of Medical Sciences and Research Centre, Chengalpattu, Tamil Nadu, India pincode:603308
Kancheepuram
TAMIL NADU |
9632431973
drswathigk414@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karpaga Vinayaga Institute of Medical Sciences and Research Centre |
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 |
| Comparator Agent |
conventional laryngoscopy guided intubation |
measurement of optic nerve sheath diameter following conventional laryngoscopy |
| Intervention |
Vedio larygoscopy guided intubation |
Measurement of optic nerve sheath diameter following vedio larygoscopy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 & 2
age from 18 years to 60 years those willing to participate |
|
| ExclusionCriteria |
| Details |
Patient with difficult airway
previous history history of difficult airway
ASA 3 & 4 Patient
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the raise in intracranial pressure using optic nerve sheath diameter |
Immediate after Intubation (0 min), 5 min, 10 min post-intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe for hemodynamic variation with two different intubating techniques |
Before intubation and 10 minutes post intubation |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Endotracheal intubation is known to increase sympathetic activity and in turn increase the intracranial pressure which can be endured in normal healthy patients but can pose a difficulty in patients with multiple comorbidities.To assess the changes in ICP we used ONSD as a surrogate marker in this study.In this study we are comparing optic nerve sheath diameter following intubation with video laryngoscopy verses conventional laryngoscopy. |