| CTRI Number |
CTRI/2025/03/083499 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Lung USG Vs chest auscultation as a marker of atropinisation in patients with acute organophosphate poisoning: A randomised controlled trial |
|
Scientific Title of Study
|
Lung USG VS chest auscultation as a marker of atropinisation in patients with acute organophosphate poisoning |
| 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 Satyabrata Guru |
| Designation |
Associate Professor |
| Affiliation |
AIIMS,Bhubaneswar |
| Address |
Room-401, New trauma centre, AIIMS, Bhubaneswar,Sijua,Patrapada
Plot-46/A Bivab Estate, Bhubaneswar, Odisha
Khordha
ORISSA
751019
India |
| Phone |
06742476671 |
| Fax |
|
| Email |
satyabrataguru25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devanand V |
| Designation |
P.G Student |
| Affiliation |
AIIMS,Bhubaneswar |
| Address |
Resident Room, New trauma centre, AIIMS, Bhubaneswar ,Sijua,Patrapada
Khordha
ORISSA
751019
India |
| Phone |
09497729910 |
| Fax |
|
| Email |
devanandv312@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyabrata Guru |
| Designation |
Associate PROFESSOR |
| Affiliation |
AIIMS,Bhubaneswar |
| Address |
Room-401, New trauma centre, AIIMS, Bhubaneswar,Sijua,Patrapada
Plot-46/A Bivab Estate, Bhubaneswar, Odisha
Khordha
ORISSA
751019
India |
| Phone |
06742476671 |
| Fax |
|
| Email |
satyabrataguru25@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS,Bhubaneswar, Sijua, Ptrapada, Bhubaneswar, Odisha, India, Pin code-751019 |
|
|
Primary Sponsor
|
| Name |
AIIMS,BHUBANESWAR |
| Address |
SIJUA, PATRAPADA, BHUBANESWAPIN-751019 |
| 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 Satyabrata Guru |
AIIMS |
Room-401, New Trauma centre, AIIMS Bhubaneswar
Khordha
ORISSA |
09438641011
satyabrataguru25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS,Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T600||Toxic effect of organophosphate and carbamate insecticides, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chest auscultation |
Using chest auscultation for diagnosing atropinisation in OP poisoning patient |
| Intervention |
LUNG USG |
Using lung USG for diagnosing atropinisation in OP poisoning patient. starting dose is 2mg and every 5 minutes the dose shall be doubled till atropinisation. The route shall be intravenous. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
i. All patients above 18 years of age from either gender with history of acute organophosphate poisoning presenting within 24hours and its clinical toxidrome.
ii. Patients who are willing to give informed consent and actively participate in the study.
|
|
| ExclusionCriteria |
| Details |
i. Patients with any other poisoning other than organophosphorus compounds.
ii. Patients with history of heart diseases or other causes of pulmonary oedema / lower respiratory tract infection or other pulmonary co-morbidities.
iii. Patients requiring mechanical ventilation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time and amount of atropine required for atropinisation in case of acute organophosphate poisoning on using lung USG vs chest auscultation as a marker of atropinisation. |
To compare the time and amount of atropine required for atropinisation in case of acute organophosphate poisoning on using lung USG vs chest auscultation as a marker of atropinisation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the patient outcome in terms of mortality/ ICU admission/ discharge.
2. To compare the development of intermediate syndrome in patients
|
20 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/04/2025 |
| 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="1"
Months="6"
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 is a randomised controlled trial comparing lung us vs chest auscultation as marker of atropinisation in patients with acute organophosphorus poisoning . Lung USG has a diagnostic accuracy of 95% for detecting alveolar interstitial syndromes compared to 55% with chest auscultation. We intend to include patients with OP poisoning with age above 18 years. Here we will compare the amount of atropine required for atropinisation in OP poisoning patients using lung USG vs chest auscultation as marker of atropinisation. Our sample size is 40. |