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临床试验/CTRI/2026/04/109249
CTRI/2026/04/109249尚未招募不适用

Drone-delivered Haemorrhage control and Scene safety kit for highway trauma in India: A stepped wedge pilot study

Centre of Excellence for Truma & Burns, MOHFW1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2026年5月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
180
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 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).

排除标准

  • 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.

研究者

发起方
Centre of Excellence for Truma & Burns, MOHFW
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Manu Ayyan

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

研究点 (1)

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