| CTRI Number |
CTRI/2023/12/060862 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
31/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
A state level Gap assessment and strengthening acute poisoning managment at various centres of Puducherry |
|
Scientific Title of Study
|
A state level Gap assessment and strengthening of current status of
care given to patients presenting with acute poisoning in primary and
tertiary care centres of Puducherry |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manu Ayyan |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute Of Postgraduate Medical Education and Research |
| Address |
First Floor Office,EMSD Building, JIPMER, Dhanvantri Nagar,Puducherry
Pondicherry
PONDICHERRY
605010
India |
| Phone |
9846556133 |
| Fax |
|
| Email |
manuayyan@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manu Ayyan |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute Of Postgraduate Medical Education and Research |
| Address |
First Floor Office,EMSD Building, JIPMER, Dhanvantri Nagar,Puducherry
Pondicherry
PONDICHERRY
605010
India |
| Phone |
9846556133 |
| Fax |
|
| Email |
manuayyan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manu Ayyan |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute Of Postgraduate Medical Education and Research |
| Address |
First Floor Office,EMSD Building, JIPMER, Dhanvantri Nagar,Puducherry
Pondicherry
PONDICHERRY
605010
India |
| Phone |
9846556133 |
| Fax |
|
| Email |
manuayyan@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research,Anasari Nagar,New Delhi |
|
|
Primary Sponsor
|
| Name |
Indian council of medical research |
| Address |
Ansar Nagar, New Delhi |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
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 |
Jawaharlal Institute Of Postgraduate Medical Education and Research |
First Floor EMSD Office
Departmet of Emergency Medicine and Trauma
EMSD Building
Dhanvantri Nagar
Puducherry
Pondicherry
PONDICHERRY |
9846556133
manuayyan@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Institute Of Postgraduate medical education and research Institutional Ethics committee Interventional studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acute poisoning managment training bundle |
A training module called Acute poison management bundle (APMB) will be developed on the basis of burden and gaps identified in initial acute poisoning management.
This module will be modeled on the Emergency care System Framework by the World Health Organisation modified for poisoning management based on level of care – primary and secondary care bundles with appropriate referral protocols.
This training program will be designed to include didactics and hands on sessions on how to initially manage and stabilise a poisoning victim. The training will be given to doctors, nurses and paramedics. A management checklist will be handed over to the participants attending the training program. The duration of the intervention will be 6 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients ≥ 18 years
presenting to emergency department of study sites with
alleged history of poisoning. |
|
| ExclusionCriteria |
| Details |
Patients presenting with bites and
stings and patients in cardiac arrest or brought dead on arrival. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
i) To identify the current gaps in the emergency care
delivery to the patients presenting with various poisonings
at different levels of health care in Puducherry
ii) To develop a training program to strengthen the
management of acute poisoning given by medical and
paramedical health care team and to test a 6 month pilot
intervention in primary, secondary and tertiary levels of care |
6 months,12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To explore the facilitators and barriers in implementation of the pilot Poisoning management intervention among the emergency care providers |
18 months |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Poisoning is a significant global health problem. World Health Organisation (WHO) estimated in 2016 that unintentional poisoning caused 106683 deaths and loss of 6.3 Million years of healthy life (DALYS). It was also estimated that about 20 % global suicides are due to pesticide poisoning.1-3 According to national crime records Bureau of India in 2020 about 38336 patients committed suicides by poisoning which accounts for about 4 suicides by poisoning per hour in our country.4 National Health mission of Tamil Nadu had launched the Tamil Nadu Accident and emergency Initiative (TAEI) in 2017 for reducing mortality related to trauma and emergencies. One of the six major pillars in achieving this was identified as appropriate management of acute poisoning in emergency departments. Poisoning is a time dependent emergency and like all other emergency requires a trained specialist to appropriately diagnose and treat. Emergency care systems and facility based care in India are is in its infancy, and it suffers from fragmentation of care right from prehospital care to facility based care both in government as well as private sectors. In a recent country level assessment done under NITI Ayog on gap assessment of emergency and trauma care about 4% of emergency admissions accounted to be for poisoning. This study highlighted the lack of trained manpower equipment’s, essential medications like antidotes for specific poisoning and written protocols for managing these patients. Managing patients with poisoning requires trained manpower, knowledge of various toxins and specific antidotes and decontamination measure to be done as soon as possible at the first medical contact (in the emergency departments). Thus, the proposed study aims to identify the current gaps in the emergency care delivery to the patients presenting with various poisoning at different levels of health care in Puducherry, also to develop a training program to strengthen the management of acute poisoning given by medical and paramedical health care team |