| CTRI Number |
CTRI/2026/04/109249 [Registered on: 23/04/2026] Trial Registered Prospectively |
| Last Modified On: |
23/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Health System Research ] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Drone support for ambulance services |
|
Scientific Title of Study
|
Drone-delivered Haemorrhage control and Scene safety kit for highway trauma in India: A stepped wedge pilot study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manu Ayyan |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
First floor,Room no 9, EMS office, Emergency Medicine and Trauma department ,EMS building, Jipmer Campus, Gorimedu, Puducherry - 605006
Pondicherry PONDICHERRY 605006 India |
| Phone |
9846556133 |
| Fax |
|
| Email |
manuayyan@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Manu Ayyan |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
First floor,Room no 9, EMS office, Emergency Medicine and Trauma department ,EMS building, Jipmer Campus, Gorimedu, Puducherry - 605006
Pondicherry PONDICHERRY 605006 India |
| Phone |
9846556133 |
| Fax |
|
| Email |
manuayyan@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Manu Ayyan |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
First floor,Room no 9, EMS office, Emergency Medicine and Trauma department ,EMS building, Jipmer Campus, Gorimedu, Puducherry - 605006
Pondicherry PONDICHERRY 605006 India |
| Phone |
9846556133 |
| Fax |
|
| Email |
manuayyan@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Centre of Excellence for Truma & Burns, MOHFW |
| Address |
COE, Jipmer,JIPMER Campus Rd, Dhanvantari Nagar, Gorimedu, Puducherry - 605006 |
| Type of Sponsor |
Government medical college |
|
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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 Manu Ayyan |
Pondicherry |
First floor, EMS office,EMS building, Jipmer Campus, Gorimedu, Puducherry - 605006 Pondicherry PONDICHERRY |
9846556133
manuayyan@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee- Interventional Studies Jipmer, Puducherry |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T799||Unspecified early complication oftrauma, (2) ICD-10 Condition: T14||Injury of unspecified body region, (3) ICD-10 Condition: T794||Traumatic shock, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Existing Prehospital care |
ambulance dispatch with on-scene care by EMT for every call recived till 1 year |
| Intervention |
Standard care plus immediate Unmanned Aerial Vehicle (UAV)dispatch |
UAV dispatch carrying a bleeding control unit and on-scene remote guidance for every call recived till 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
-112/108 calls routed to the ambulance dispatch centre(Call center) from within the cluster boundaries during the study period.
-Dispatcher classification as trauma with “external haemorrhage” or “amputation/major limb trauma.”
-Scene accessible for drone overhead delivery (open rooftop/roadside/field).
|
|
| ExclusionCriteria |
| Details |
Airspace/operational no-go (severe weather, a notice to airmen (NOTAM), VIP movement), unsafe crowds, or lack of GPS lock.
Indoor entrapment without line of sight; high-rise window only access.
Mass-casualty incidents (handled under separate protocols).
Interfacility transfers |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to first effective haemorrhage control :Time (in minutes) from 112/108 call receipt (T0) to the first documented application of a tourniquet, pressure bandage, or haemostatic gauze to a bleeding wound at the scene |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Eligibility and Coverage: Number and proportion of eligible calls identified per cluster-period; proportion of eligible calls where UAV dispatch was attempted as per protocol |
0 minutes |
| Operational Performance (Drone Dispatch Success): Proportion of episodes with successful dispatch, launch within 5 minutes, and successful kit delivery to scene |
5 minutes |
| Data Completeness: Proportion of study episodes with complete primary outcome timestamp data — specifically, both call receipt time (T0) and time of first effective haemorrhage control — along with other key operational timestamps (dispatch time, launch time, kit delivery time), captured across EMS logs, UAV logs, and dispatcher logs |
Assessed per episode, reported cumulatively at the end of each cluster-period and at the end of the overall study period |
| Safety : Number and nature of drone-related and kit-related adverse events |
Continuously monitored and reported per episode throughout the study |
|
|
Target Sample Size
|
Total Sample Size="180" Sample Size from India="180"
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)
|
27/05/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background
Road traffic injuries (RTIs) remain one of the leading causes of preventable mortality worldwide. India accounts for nearly 11% of global RTI deaths, with over 150,000 fatalities annually [1,2]. Emergency medical diseases contribute to over one-third of deaths nationally, with haemorrhage being the single largest preventable cause [3,4]. Prehospital emergency care in India is characterised by fragmentation and significant variability in access, resources, and quality of service across the country. India’s Emergency Medical Services (EMS) system represents a patchwork of public, private, and non-governmental initiatives, each with different operational models and standards. While the evolution of EMS in India has accelerated over the past two decades, fundamental challenges remain that impact its effectiveness, particularly for trauma and time-critical conditions (1). The World Health Organisation’s Emergency Care System (ECS) framework emphasises the need for timely and coordinated interventions at both prehospital and facility levels (5). The 2021 country-level assessment by NITI Aayog reported limited ambulance availability, delayed dispatch times, and a shortage of trained paramedics (2). Unmanned aerial vehicles (UAVs), commonly referred to as drones, have become an important tool for medical logistics worldwide. In India, feasibility studies in the Himalayan region demonstrated that 15 UAV sorties successfully transported medicines and diagnostic samples under challenging conditions, reducing delivery times by 50-75% (6). Internationally, UNICEF trials in Vanuatu achieved <2 m landing accuracy within two meters for vaccine delivery, and computational models have highlighted the potential of UAVs to strengthen vaccine supply chains (7-12).
Rationale Effective haemorrhage control is a critical factor in trauma survival. Evidence indicates that tourniquet application in combat trauma significantly increases survival rates(13). Community initiatives, such as the STOP THE BLEED® program, have shown that training laypersons improves their ability to control bleeding, supporting the rationale for providing bystanders with UAV-delivered haemorrhage control kits (14). Feasibility studies indicate drones can reduce delivery times by 50–75% and arrive at scenes significantly earlier than ambulances.(15). Furthermore, providing laypersons with tools improves their ability to control bleeding, supporting bystander-focused interventions.
Novelty Trauma outcomes in India remain poor, with delayed First Medical Contact (FMC) and inadequate bleeding control contributing to preventable deaths [16-19]. Integrating UAVs into the INDIA-EMS digital backbone [1] addresses gaps in timeliness, prearrival notification, and scene safety. It also leverages existing metrics (time to FMC, door-to-CT, door-to-OT, TXA within 8h) for evaluation.
Expected Outcomes This study will provide the first Indian implementation evidence for UAV-delivered haemorrhage control kits, aligning with the WHO ECS framework and national trauma care priorities. If successful, this model may be scaled nationwide to reduce preventable trauma mortality. This study will be initiated under the prehospital and emergency care of the Centre of Excellence (CoE) -National Programme for Prevention and Management of Trauma and Burns (CoE-NPPMT&B), following due approval from the competent authority. |
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