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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  
Nil 
 
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 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
 
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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