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CTRI Number  CTRI/2024/10/075232 [Registered on: 14/10/2024] Trial Registered Prospectively
Last Modified On: 16/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Quality Improvement Programme in Poisoning Management 
Scientific Title of Study   Development and Piloting of Stewardship Programme in Toxicological Management in Tertiary Care Hospital 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Veekshitha S Shetty 
Designation  Student 
Affiliation  Manipal Academy Of Higher Education 
Address  Department of pharmacy practice, Manipal College Of Pharmaceutical Sciences, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7483498426  
Fax    
Email  veekshithashettyy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Girish Thunga 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9880151127  
Fax    
Email  girish.thunga@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Girish Thunga 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9880151127  
Fax    
Email  girish.thunga@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education Madhav Nagar, Manipal, Karnataka, India, 576104  
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Girish Thunga  Kasturba Hospital Manipal  Room number 22 Emergency Department KMC Manipal
Udupi
KARNATAKA 
9880151127

girish.thunga@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T603||Toxic effect of herbicides and fungicides, (2) ICD-10 Condition: T600||Toxic effect of organophosphate and carbamate insecticides, (3) ICD-10 Condition: T604||Toxic effect of rodenticides, (4) ICD-10 Condition: T630||Toxic effect of snake venom,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Phase I: Acute poisoning cases of Organophosphate, Paraquat, Snake bite and Zinc Phosphide admitted during the period of 2022-2023.
Phase IIa : Physicians in Emergency department who are willing to give consent.
Phase IIb: Panel members with clinical expertise and handling of acute poisoning cases.
Phase III: Acute poisoning cases with selected poisoning for stewardship programme, age above 18 years. 
 
ExclusionCriteria 
Details  Phase IIa : Physicians who are not willing to give consent
Phase III: The study of unknown poisoning, mixed poisoning, children with acute poisoning, pregnancy, acute poisoning with incomplete information on the patient card, referral cases 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The project focused on quality improvement of hospital with respect to the adherence to guideline and protocol and presented in terms of percentage. The deviations are noted and reported to physician accordingly.  Two points
After 1 week and 2 weeks of admission 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="314"
Sample Size from India="314" 
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)   01/02/2025 
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="2"
Months="0"
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    The initial management of poisoning cases is challenging due to lack of guidelines, laboratory investigation and diagnostic evaluation which could ultimately result in inappropriate therapeutic intervention during the admission of poisoned patients. Also, making decisions can be challenging due to lack of evidence from high quality antidote studies, variability in updating source and some regional variations in their use. The study is to understand the need for the development and implementation of toxicology stewardship programme in emergency setting of tertiary care hospital due to increasing pitfalls in the management of poisoning cases.

 The study is conducted in three phases:

Phase I: Retrospective audit: Based on the frequency of admission, cases of Organophosphate, Paraquat, Snake bite and Zinc phosphide poisoning will be selected for the study. All the retrospective data such as physical examination, routine biochemical investigations, hematology, urine analysis, severity score and management of respective poisoning cases admitted during the period of 2022-2023 will be collected from medical record department based on ICD coding. Most four common poisoning cases with maximum admission rate will be selected for the audit purpose.

Phase IIa: Qualitative interview to get expert opinion: The Qualitative interview guide will be prepared based on the literature and it focused on important domains such as  type of poison, involvement of Health care Professionals, opinion regarding training program, delivering feedbacks to physicians and evaluation of the stewardship programThe qualitative guide will be evaluated with five experts in the domain by protocol refinement method. The final interview guide will be administered among fifteen to twenty physicians after taking consent, telephonic or face to face interview for about thirty minutes till data saturation. The collected data will be stored in the investigator laptop with protected password and later transferred into verbatim. Themes will be generated by using Nvivo software and final themes are utilized for developing a stewardship plan.

Phase IIb: Development of a stewardship plan and its validation: Literature review will be done by thorough assessment of the available literature on stewardship plans to gather data and analyze the body of work in the field. Data will be extracted based on the relevance to our plan after a thorough reading and analysisBased on the literature review and qualitative interview with physician, a draft of stewardship plan will be developed. A draft stewardship plan includes clinical assessment details such as Airway, Breathing and Circulation, requirement of oxygen, requirement of IV fluid administration, GI decontamination or any suitable method of decontamination, administration of Antibiotics, Antidote as per requirement of management of specific poison with respect to guideline or standard care procedure.
The validation will be done using the Delphi methodology which includes selection of panel members, presenting the stewardship draft to the expert panel and lastly conducting delphi rounds.
The finalized stewardship plan will be implemented in two cases of each selected poisoning cases and any modification with respect to availability of data or adding a new component will be noted and final validation will be done by focus group discussion.

Phase III: Piloting and implementation of stewardship plan: Two cases will be selected from each poisoning cases and checked for availability of the data and any major deviations observed will be incorporated in the stewardship plan accordingly with respect to the management of poisoning cases. These incorporated elements will be presented to the focus group discussion informally to finalize the stewardship plan. The final plan will be implemented in all the ICU settings after taking patient consent and patient will be followed from the day of admission to the day of discharge. The deviations, adherence and special actions taken will be noted and at the end all the findings will be concluded and presented to the physician to get their opinion. With the help of mutual agreement, a draft protocol will be prepared for selected poisoning and circulated among ICU doctors for final input.
Validation of the protocol is done by selecting team of experts after taking appropriate consent. Briefly they have oriented for study procedures and its outcome. After obtaining consent, the final validated protocol will be circulated to them for input. Necessary changes will be incorporated, and final draft will be used as a reference copy for hospital with Medical Superintendent approval.

This project focused on quality improvement of hospital with respect to the adherence to guideline and protocol and presented in terms of percentage. The deviations are noted and reported to physician and ultimately achieving improvement in patient care.

 
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