| CTRI Number |
CTRI/2024/04/066546 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating POP score in predicting need for mechanical ventilation and severity and outcome in organophosphorus poisoning cases admitted in Sir Takhtasinhji hospital Bhavnagar |
|
Scientific Title of Study
|
Usefulness of Peradeniya Organophosphorus poisoning(POP) score in Management of OP Poisoning cases admitted in Sir Takhtasinhji Hospital Bhavnagar |
| 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 Ketul Patel |
| Designation |
Resident Doctor - 2nd Year |
| Affiliation |
GMC Bhavnagar |
| Address |
OPD Room 62 , Medicine Department ,Sir T Hospital Bhavnagar 364001, Gujarat
Bhavnagar
GUJARAT
364001
India |
| Phone |
9427530574 |
| Fax |
|
| Email |
ketulvpatel19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alpesh Vora |
| Designation |
Associate Professor |
| Affiliation |
GMC Bhavnagar |
| Address |
Medicine department , Sir t hospital,Bhavnagar (364001) Gujarat
Bhavnagar
GUJARAT
364001
India |
| Phone |
9824206936 |
| Fax |
|
| Email |
drarvora73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ketul Patel |
| Designation |
Resident Doctor - 2nd Year |
| Affiliation |
GMC Bhavnagar |
| Address |
OPD Room 62 , Medicine Department ,Sir T Hospital Bhavnagar 364001, Gujarat
Bhavnagar
GUJARAT
364001
India |
| Phone |
9427530574 |
| Fax |
|
| Email |
ketulvpatel19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of medicine,Sir t hospital bhavnagar |
|
|
Primary Sponsor
|
| Name |
Dr Ketul Patel |
| Address |
Department of medicine ,Sir t hospital bhavnagar |
| Type of Sponsor |
Government medical college |
|
|
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 Ketul Patel |
Sir t hospital ,Bhavnagar |
Emergency room no 17,Department of medicine ,Sir t hospital ,Bhavnagar
Bhavnagar
GUJARAT |
9427530574
ketulvpatel19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTEE GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T489||Poisoning by, adverse effect of and underdosing of other and unspecified agents primarily acting on the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients (12) years of age admitted with history of OP ingestion and/or symptoms suggestive of and level of serum cholinesterase suggestive of (less than 2000 units) acute organophosphorus poisoning
|
|
| ExclusionCriteria |
| Details |
Patient who already had received treatment from outside of hospital
Patients with history of co-ingestion of other substances
Patients presenting after 48 hours of ingestion
Patients having pre-existing Chronic uncontrolled diseases except Psychiatric disorders
Pregnant female
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Usefulness of Peradeniya organophosphorus poisoning (POP) score in management of OP poisoning cases |
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Usefulness of POP score in early assessment of severity of OP poison case in resource limited setup |
9 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
11/05/2024 |
| 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="0"
Months="9"
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
|
This study is to determine the usefulness of peradeniya organophosphorus poisoning (POP) score in management of OP poisoning cases admitted in tertiary care hospital. Patient fulfilling inclusion criteria will be examined and as per case record form , data collection will be done. Each patient will be assigned POP score based on collected data.subsequently all the outcome variables ( Requirement of atropine for bolus and infusion,need for mechanical ventilation,complication(intermediate syndrome),length of hospital stay,mortality ) will be collected from the case sheet of the patient at the end.Descriptive analysis will be done. |