Clinical Research Directory

Analysis of the Efficacy of Pressure Pad vs Pressure Bandage Immobilisation for Snake Bite First Aid in Healthy Volunteers.

Snake bite affects thousands of Australians every year, but few die as a result due to high quality first aid and timely medical care. Good first aid should be simple, standardised, use minimal or readily available equipment, and be able to be utilised effectively with no or minimal training by the rescuer. Over time the first aid methods used to manage snake bite in Australia have been questioned due to issues with efficacy, and some emerging evidence of harm from their use. There is little experimental data in the literature to support current first aid practices, and what exists suggests further research is required. This study aims to examine and compare the effectiveness of two first aid methods by tracking the movement of a mock venom through the body when each first aid method is used. This will provide important information about the suitability of current techniques used in Australia and whether a proposed simpler alternative technique is as effective. Currently, initial treatment of snake bite involves early first aid with the application of a pressure bandage and immobilisation (PBI) of the limb. There is limited data to support the basis of this technique and emerging evidence of harm when applied incorrectly. This project sets out to evaluate PBI compared to another technique involving the application of a pressure pad (PP) at the bite site (which is easier to do, and used in many countries outside of Australia). The project aims to determine whether each technique is effective, and whether the PP technique is at least as effective as PBI. To do this 24 participants will be recruited to undergo study with mock venom injected into their hand or foot and having either PBI or PP applied. The mock venom will then be traced with a gamma camera to determine rate of flow through the lymphatic system, which is how venom travels in the body. It is expected that the project will demonstrate the efficacy of both techniques, and that the PP will be at least as effective as PBI. This will provide a basis for change in the current first aid recommendations for snake bite first aid in Australia, and improve the care provided.

A Prospective Observational Study to Determine the Predictive Accuracy of Snakebite Severity Score (SSS) in Identifying Syndrome-Specific Core Outcome Parameters Amongst Envenomated Patients Presenting to the Emergency Department.

India reports \~58,000 snakebite deaths/year, over 50% of global mortality. Clinical outcomes of antivenom may vary due to regional venom differences, delayed access to care, ineffective use of existing polyvalent antivenom. There is a need for an India-specific severity assessment tool because it improves risk stratification \& clinical decisions ,guides antivenom use, supports rural healthcare infrastructure, reduces morbidity, mortality, and financial burden. Existing scoring systems lack validation for Indian envenomation patterns. Variability in venom (both inter- and intra-species) leads to inconsistent clinical outcomes.Misapplication of non-Indian tools may cause: Inaccurate severity grading, inappropriate antivenom use, poor patient outcomes. PRIMARY OBJECTIVE: ● To determine the predictive accuracy of Snakebite Severity Score (SSS) done at the time of presentation in identifying syndrome specific core outcomes for snakebites. SECONDARY OBJECTIVES: * To evaluate the predictive accuracy of SSS in identifying patients at risk of mortality at 6 weeks * To determine the predictive accuracy of modified Snakebite Severity Score (mSSS) done at the time of presentation in identifying syndrome specific core outcomes for snakebites METHODOLOGY Study Duration: 18 months (Proposed) * Setting: Emergency Dept, Jubilee Mission Medical College * Sampling method :consecutive sampling * Sample Size Calculation: n = Z₍₁-α/₂)2 x SN (100-SN ) / l2 x P = 220 * Confidence Level: 95% (Z₍₁-α/₂₎ = 1.96) * Expected Sensitivity: 97% * Relative Allowable Error: 5% (l = 0.05) * Proportion: Based on core outcome occurrence = 0.22 * Drop-out Rate Assumed: 20% * minimum sample size = 264 Reference: Based on data from Dart et al."Validation of a Severity Score for the Assessment of Crotalid Snakebite,1999" INCLUSION AND EXCLUSION CRITERIA Inclusion Criteria: * All patients 'clinically suspected snakebite' * Presenting within 24 hours of the event * Age ≥18 years * Providing written informed consent Exclusion Criteria * Stings or bites other than snake * All patients who received antivenom or blood products at another institute * All patients with known hematological malignancies, coagulation disorders, chronic liver or renal failure * All patients known to be on warfarin, heparin or any newer oral or injectable anticoagulants * Individuals withdrawing a consent later on. STUDY FLOW AND DATA MANAGEMENT Study Flow: Enrollment \& Initial ED Assessment: History, examination, bite documentation, SSS scoring Baseline labs as per institutional protocol Monitoring \& Follow-Up Timepoints: T0: At presentation T+3h, +6h, +12h: Direct proforma, records review T+48h: Medical records Day 30 and Day 42 : Medical records \& telephonic follow-up Outcomes Monitored: Neurotoxicity, haemotoxicity , coagulopathy, local damage, AKI, hypotension No interference with clinical care or treatment decisions. DATA ANALYSIS PLAN: Software: SPSS v29 Continuous variables are measured by using Mean+/-SD or median IQR Categorical variables are reported as frequencies and percentages. ROC curve analysis for SSS and mSSS. Logistic regression for mortality. Subgroup and domain-wise analysis. ETHICAL CONSIDERATIONS: Ethics approval to be obtained. Informed consent will be ensured. Data anonymized and securely stored. No interference with patient treatment.