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临床试验/CTRI/2025/08/093720
CTRI/2025/08/093720尚未招募2 期

Development and Evaluation of Pre Hospital Resuscitation Kits for Trauma and Infectious Disease in Advanced Life Support ALS Ambulances A Simulation-Based Study

Kasturba Medical College Manipal Academy of Higher Education1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年8月31日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
16
试验地点
1
主要终点
Positive qualitative assessment of the new Pre Hospital Resuscitation kits.

研究概览

简要总结

This study involves the development and evaluation of a new Pre Hospital Resuscitation Kit and an Infection Control Kit, guided by standard operating procedures and expert validation. After obtaining ethical approvals and informed consent, participants will be enlisted and oriented for a high-fidelity simulation conducted in an ALS ambulance setup. The simulation includes 28 scenarios 14 using traditional kits and 14 with the newly developed kits with performance time recorded. Contamination levels will be assessed using UV powder and image analysis to evaluate surface contact. Participant feedback will be collected through a validated questionnaire focusing on ergonomics, completeness, and usability of the kits. Data will be analyzed using JAMOVI 4.0, with statistical methods including test-retest and stratified analysis.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • EMTs and Paramedics are currently working in the pre-hospital setting, including the EMTs who are under training.
  • Participants securing at least 50% in the Pre-Test Questionnaire.

排除标准

  • Nurses Participants with pre-existing medical conditions, allergies to the glow powder, equipment used during the simulation.

结局指标

主要结局

Positive qualitative assessment of the new Pre Hospital Resuscitation kits.

时间窗: At Baseline (Immediately after the assessment of the Traditional Advanced Life support Ambulance kits)

次要结局

  • Reduced transmissibility and reduced time to standardized care in the simulation model.(The kits integrated infection control components and organized layout support safer and faster intervention delivery during pre-hospital emergencies.)

研究者

发起方
Kasturba Medical College Manipal Academy of Higher Education
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Avinash Bhat

Manipal College of Health Professions MAHE Manipal

研究点 (1)

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