- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07581301
Administering Atropine Through Autoinjectors Within Ambulance Services for Poisoning Patients in Sri Lanka's North Central Province (FAST-AID)
Feasibility of Using Ambulance Services to Administer Atropine Using Autoinjectors in Farming Communities in the North Central Province, Sri Lanka
Pesticide poisoning remains one of the most serious public health challenges in rural Sri Lanka, particularly in the North Central Province (NCP), where intensive farming and heavy pesticide use have led to high rates of accidental and intentional poisoning. Although the antidote, atropine, is routinely used in hospitals, delays in receiving treatment often occur because patients must travel long distances before reaching care. Early initiation of treatment is critical, and survival depends on the speed with which atropine is administered.
The government's free 1990 Suwa Seriya ambulance service, established in 2016, provides emergency transport across Sri Lanka but currently has limited capacity for administering time-sensitive antidotes. Community consultations conducted during an earlier study revealed that people preferred life-saving treatments such as atropine to be managed through the formal health system, rather than stored in villages. This led to the idea of exploring whether ambulance staff could safely use atropine autoinjectors; simple, pre-filled devices that deliver the drug quickly and can safely be used even by non-medical professionals.
The FAST-AID study aims to assess the feasibility of introducing atropine autoinjectors into Sri Lanka's emergency ambulance system for use in pesticide poisoning cases. The main question is:
How feasible is it to integrate atropine autoinjectors into the ambulance service to provide earlier treatment for pesticide poisoning patients? Secondary questions explore (1) how ambulance coverage and travel routes affect timely administration; (2) how ambulance and hospital staff experience the use of the devices; and (3) how patients perceive the care they received.
The study will be carried out in the Anuradhapura District of the NCP, in collaboration with the Suwa Seriya ambulance service and selected hospitals. Two geographical clusters, one densely populated and one more remote, have been chosen to compare different service conditions. Around 30 pesticide poisoning patients will receive atropine using autoinjectors during ambulance transport, under guidance from an on-call emergency physician.
Data will be collected through several complementary methods:
- Operational data from ambulance and hospital records (e.g., response times, use of autoinjectors, patient outcomes).
- Geographic mapping (GIS) of ambulance coverage to assess accessibility and response patterns.
- Focus group discussions with ambulance and hospital staff to explore training, practical challenges, and perceptions of the intervention.
- Semi-structured interviews with patients to understand their lived experience of emergency care.
- Participant observation in ambulances and hospitals to capture the everyday realities of emergency response.
Participants will be adults (aged 18 or above) who either work in the ambulance or hospital system or who have experienced pesticide poisoning and received atropine during the study period. All participants will provide written informed consent.
The research team will include Sri Lankan and UK collaborators from the University of Edinburgh and the South Asian Clinical Toxicology Research Collaboration (SACTRC).
By assessing the operational and social feasibility of using atropine autoinjectors in ambulances, this study aims to strengthen Sri Lanka's emergency response system and provide a foundation for a larger trial that could ultimately help save lives of those experiencing pesticide poisoning.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Michael Eddleston, PhD
- 전화번호: +44-131-242-1383
- 이메일: M.Eddleston@ed.ac.uk
연구 장소
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North Central Province
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Anuradhapura, North Central Province, 스리랑카, 50000
- South Asian Clinical Toxicology Collaboration
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연락하다:
- Indika Gawarammana, PhD
- 전화번호: +94 81 222 4125
- 이메일: indikagaw@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
The study will involve three participant groups drawn from the Anuradhapura District in the North Central Province of Sri Lanka:
- Ambulance staff (Emergency Medical Technicians, drivers, and support staff) working within the Suwa Seriya 1990 ambulance service who administer atropine autoinjectors during the pilot period.
- Hospital staff (doctors and nurses) working in Emergency Treatment Units (ETUs) of the hospitals in two geographical clusters, one densely populated and one more remote, that receive pesticide poisoning patients treated with atropine autoinjectors.
- Pesticide poisoning patients (men and women aged 18 years and above) who have received atropine via autoinjector from ambulance staff during the pilot period.
The total expected sample size is approximately 30 pesticide poisoning patients, and all ambulance and hospital staff directly involved in these 30 cases will also be invited to participate in focus group discussions.
설명
Inclusion Criteria:
- Participants over the age of 18 who are willing and able to provide written informed consent will be asked to participate in the study.
- Ambulance staff directly involved in the management and response to pesticide poisoning cases during the intervention period in the selected two geographical clusters.
- Doctors and nurses from selected hospitals in the two geographical clusters who managed pesticide poisoning patients that received atropine via autoinjectors administered by ambulance staff during the intervention period.
- Pesticide poisoning patients managed by Suwa Seriya ambulances in the selected two geographical clusters of the Anuradhapura district during the intervention period.
Exclusion Criteria:
- Participants who are unwilling or unable to provide written informed consent will not be included in the study.
- Participants who do not speak Sinhala.
- Participants under the age of 18 years.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Patients with suspected pesticide poisoning attended by ambulance services
The cohort includes individuals with suspected pesticide poisoning attended by participating Suwa Seriya 1990 ambulances in the North Central Province of Sri Lanka.
Cases are identified at the pre-hospital stage based on reported exposure and clinical presentation, reflecting real-world emergency conditions where diagnostic confirmation is often unavailable at first contact.
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Administration of atropine via pre-filled autoinjector by trained ambulance staff of the Suwa Seriya 1990 for patients with suspected pesticide poisoning in the pre-hospital setting.
Selected ambulances will be equipped with atropine autoinjectors, and staff will receive training on identification of poisoning cases, indications for atropine use, dosing, and safe administration.
The intervention is implemented during routine emergency response, with atropine administered when clinically indicated prior to hospital arrival.
This intervention aims to enable earlier delivery of atropine and improve initial management within the emergency care pathway.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time from ambulance arrival to atropine administration
기간: From ambulance arrival at scene until hospital admission (typically within 0-2 hours)
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Measured in minutes from ambulance arrival at the scene to administration of atropine via autoinjector.
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From ambulance arrival at scene until hospital admission (typically within 0-2 hours)
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Proportion of eligible patients receiving atropine via autoinjector
기간: From ambulance arrival at scene until atropine administration or hospital admission, whichever occurs first (typically within 0-2 hours)
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Defined as the number of suspected pesticide poisoning cases attended by participating Suwa Seriya 1990 ambulances who receive atropine via autoinjector, divided by the total number of eligible cases.
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From ambulance arrival at scene until atropine administration or hospital admission, whichever occurs first (typically within 0-2 hours)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Ambulance response time
기간: From emergency call dispatch to ambulance arrival at scene (typically within 0-60 minutes)
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Time from emergency call dispatch to arrival at the scene.
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From emergency call dispatch to ambulance arrival at scene (typically within 0-60 minutes)
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Time to atropine administration (minutes) from reported pesticide exposure (ambulance records)
기간: From estimated time of exposure to atropine administration, assessed up to 6 hours
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Measured as the time interval in minutes between the estimated time of pesticide exposure (as reported by the patient or bystanders and documented by emergency medical technicians) and the time of atropine administration via autoinjector recorded in ambulance patient care records of the Suwa Seriya 1990.
This measure will be recorded only for cases where both time points are available.
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From estimated time of exposure to atropine administration, assessed up to 6 hours
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Adverse events related to atropine administration
기간: From time of atropine administration to hospital admission, assessed up to 2 hours
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Defined as the number of participants with any documented adverse reactions following atropine administration via autoinjector, as recorded in ambulance and hospital records.
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From time of atropine administration to hospital admission, assessed up to 2 hours
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Glasgow Coma Scale (GCS) score at hospital arrival
기간: At hospital admission
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Measured using the Glasgow Coma Scale (GCS), a standardized clinical assessment of level of consciousness ranging from 3 to 15, as recorded at the time of hospital admission following transport by Suwa Seriya 1990.
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At hospital admission
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- AC25185
- NIHR203140 (기타 보조금/기금 번호: National Institute of Health and Care Research, UK)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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