| CTRI Number |
CTRI/2025/10/095720 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
02/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [educational intervention] |
| Study Design |
Other |
|
Public Title of Study
|
VENOMS Helpline-A telemedical Helpline for Primary and paramedical workers treating Snakebite and other envenomation in Karnataka. |
|
Scientific Title of Study
|
Implementation and evaluation of the VENOMS Helpline by EMS personnel. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Freston Marc Sirur |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Emergency Medicine, Kasturba Medical College, Manipal Centre for Wilderness Medicine, Kasturba Medical College, Manipal Udupi KARNATAKA 576104 India |
| Phone |
09604200840 |
| Fax |
|
| Email |
sirur.freston@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Freston Marc Sirur |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Emergency Medicine, Kasturba Medical College, Manipal Centre for Wilderness Medicine, Kasturba Medical College, Manipal
KARNATAKA 576104 India |
| Phone |
09604200840 |
| Fax |
|
| Email |
sirur.freston@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Freston Marc Sirur |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Emergency Medicine, Kasturba Medical College, Manipal Centre for Wilderness Medicine, Kasturba Medical College, Manipal
KARNATAKA 576104 India |
| Phone |
09604200840 |
| Fax |
|
| Email |
sirur.freston@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Madhavnagar, Manipal, Udupi, Karnataka, India-576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Hospital Manipal |
| Address |
Kasturba Hospital Manipal Madhavnagar Manipal Udupi Karnataka 576104 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| DrFreston Marc Sirur |
Kasturba Hospital Manipal |
Department of Emergency Medicine, Kasturba Medical College, Manipal
Centre for Wilderness Medicine, Kasturba Medical College, Manipal Udupi KARNATAKA |
09604200840
sirur.freston@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants are emergency Medical technicians involved in a telemedical system for snakebite and other envenoming that supports primary health and paramedical workers. |
| Patients |
(1) ICD-10 Condition: T63||Toxic effect of contact with venomous animals and plants, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Educational intervention |
Snakebite and other Envenoming telemedical training module with medical direction protocols for snakebite, scorpion sting, hymenoptera stings etc training will be repeated for all new staff or EMTs in the telemedical console at least once and will continue till 18 months before the end of the study period or once sample size of 30- 50 is met. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All healthcare workers seeking telemedical support for snakebite and other causes of envenoming from private or public hospitals calling the VENOMS Helpline team for support. |
|
| ExclusionCriteria |
| Details |
All cases with no suspicion or confirmation of envenoming by any creature will be excluded in addition to calls from non medical individuals without an ongoing incident requiring telemedical support |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1To measure the change in EMS personnel’s knowledge of venomous species clinical signs and evidence based prehospital care before and after the training program
2training program’s impact on EMS personnel’s ability to apply appropriate prehospital interventions
3usability and perceived effectiveness of the VENOMS Helpline based on structured caller feedback and call data analysis.
4Enhanced EMT confidence in delivering pre-hospital care for envenomation incidents. |
1.after the training and 18 months after.
2.after the simulation modelled telemedical calls.
3.Feedback taken immediately after a case is closed and At the end of the two year data collection window
4.Feedback after operating the VENOMS helpline for 1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2025 |
| 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="2" Months="0" 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 presents a targeted and structured training program designed specifically for Emergency Medical Services (EMS) personnel, with a unique integration of telemedical support. The program addresses a critical gap in prehospital care—particularly in the management of envenomation cases—by equipping EMTs with both clinical knowledge and real-time decision-making support through telemedicine. Given the persistent shortage of EMTs, especially in remote and high-risk regions, this dual approach aims to optimize the existing workforce. By enabling trained professionals to access expert guidance remotely, telemedicine serves as a force multiplier. It enhances the capability of EMTs on the ground while simultaneously reducing the dependency on physical presence, allowing for quicker mobilization and more efficient use of limited resources. The training focuses on upskilling EMTs in recognizing and responding to various types of envenomation, including snake bites, scorpion stings, and other venomous exposures. Real-time teleconsultation ensures that even in high-stakes or unfamiliar scenarios, EMTs are never working in isolation. They are supported by a system that not only guides clinical decisions but also reinforces learning through applied practice. To measure the impact of this initiative, the study employs pre- and post-training assessments that evaluate knowledge gains and confidence levels. These outcomes will help validate the program’s effectiveness and provide insights for scaling similar models in other underserved areas. Ultimately, this model leverages technology not as a replacement but as an enabler—bridging gaps in availability, improving clinical outcomes, and ensuring that quality care reaches even the most inaccessible regions. |