- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Michael Eddleston, PhD
- Numer telefonu: +44-131-242-1383
- E-mail: M.Eddleston@ed.ac.uk
Lokalizacje studiów
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North Central Province
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Anuradhapura, North Central Province, Sri Lanka, 50000
- South Asian Clinical Toxicology Collaboration
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Kontakt:
- Indika Gawarammana, PhD
- Numer telefonu: +94 81 222 4125
- E-mail: indikagaw@gmail.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
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.
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Time from ambulance arrival to atropine administration
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Ambulance response time
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- AC25185
- NIHR203140 (Inny numer grantu/finansowania: National Institute of Health and Care Research, UK)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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