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临床试验/NCT07299188
NCT07299188进行中(未招募)不适用

The Effect of Using Electrically Insulated Gloves During Defibrillation on ROSC (Return of Spontaneous Circulation) Time, End-tidal CO₂ (EtCO₂) Response, Survival and Morbidity for Uninterrupted CPR: A Prospective Controlled Study in Manikins and Humans

Izmir Katip Celebi University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年11月6日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
32
试验地点
2
主要终点
MORTALITY RATE

研究概览

简要总结

Cardiopulmonary arrest is the sudden cessation of spontaneous breathing and circulation due to various causes. Cardiopulmonary resuscitation (CPR) is the set of decisions and procedures encompassing all efforts aimed at restoring spontaneous circulation. Guidelines are published at regular intervals by the American Heart Association (AHA) and the European Resuscitation Council (ERC) to ensure that these procedures are applied uniformly worldwide. According to the AHA and ERC guidelines, the latest approach to CPR is to reduce the duration of interruptions in chest compressions, which is a component of high-quality CPR. Prior to actual patient intervention, a preliminary test will be conducted on an advanced life support simulation manikin to evaluate the safety and feasibility of the method.

During cardiopulmonary resuscitation (CPR), unavoidable interruptions in chest compressions occur because contact with the patient must be broken during defibrillation and cardioversion. In this study, electrically insulated composite gloves (Class 2) will be used to ensure uninterrupted chest compressions during defibrillation, and the effect of this practice on patients' ROSC, EtCO₂, neurological outcomes, and survival rates will be evaluated comparatively with the control group.

The main objective of the study is to evaluate the effect of ensuring uninterrupted chest compressions during defibrillation using electrically insulated composite gloves on patient survival rates.

详细描述

High-quality cardiopulmonary resuscitation (CPR) performed in cases of cardiac arrest is a determinant of survival and neurological outcomes. In this context, the quality and continuity of chest compressions are considered to be parameters that directly affect return of spontaneous circulation (ROSC) and long-term survival. Current guidelines strongly recommend that chest compressions be performed continuously and that compression intervals be kept to a minimum. This is because each pause causes a significant decrease in coronary and cerebral perfusion and prolongs the time required to restore effective circulation.

Although defibrillation during CPR is vitally important, especially in shockable rhythms, chest compressions are stopped during this procedure for the rescuer's safety, leading to a temporary interruption of circulation. The literature shows that compression interruptions before and after defibrillation reduce ROSC rates, lower end-tidal CO₂ (EtCO₂) levels, and have negative effects on overall survival. Therefore, the goal is to perform all interventions during CPR, including defibrillation, as quickly as possible and without interrupting chest compressions.

Before starting this study, a preliminary test was planned on a full-body simulation manikin used in advanced life support training to evaluate the safety of the method and materials to be used. The application of uninterrupted chest compressions during defibrillation using EN 60903 Class 2 insulated gloves will be tested on this manikin; the safety of the application, equipment durability, and feasibility from the rescuer's perspective will be observed. The findings obtained will provide a preliminary assessment of the method's suitability for field conditions before proceeding to work on patients.

Recent studies have shown that when gloves providing adequate electrical insulation are used, rescuers can safely continue chest compressions during defibrillation. It has been demonstrated that electrically insulated composite gloves with high insulation properties can effectively protect the rescuer by providing resistance to defibrillation voltages. However, standard medical examination gloves do not provide adequate protection against such high voltages; simulation studies have reported that many gloves fail at voltages between 2500-4000 V, posing a risk to rescuer safety. The voltage-current relationship of different types of gloves was evaluated, and it was shown that even double-layered latex gloves allowed current to pass through at a rate of 77% against external defibrillation voltage. These findings highlight the need to use not only insulated but also highly durable special gloves to ensure the safe application of defibrillation during CPR.

Although some third-level emergency departments and intensive care units now have automated CPR devices, access to these devices can be difficult nationwide. This study was designed based on the idea that the use of electrically resistant gloves to protect against electric shock during defibrillation after detectable rhythm detection for uninterrupted CPR would prevent interruption of perfusion, which is the main goal.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with in-hospital cardiac arrest requiring CPR
  • Patients with shockable rhythms (pulseless ventricular tachycardia (VT) and ventricular fibrillation (VF))
  • Adult patients aged 18 years and older
  • Patients capable of providing informed consent or for whom consent can be obtained through a legal representative

排除标准

  • Out-of-hospital cardiac arrests
  • Patients who received CPR outside the emergency department
  • Traumatic patients
  • Pregnant patients
  • Patients under 18 years of age
  • Terminally ill patients

结局指标

主要结局

MORTALITY RATE

时间窗: UP TO 36 MONTHS

The study will be conducted using electrically insulated composite gloves (Class 2 Starline Linepro insulated gloves) to ensure that chest compressions continue uninterrupted during defibrillation and to determine the effect of this practice on patient survival rates.

次要结局

  • ROSC (return of spontaneous circulation) times(UP TO 36 MONTHS)
  • End-tidal carbon dioxide (EtCO₂) response(UP TO 36 MONTHS)
  • Its effect on post-CPR neurological outcomes will be evaluated(UP TO 36 MONTHS)

研究者

发起方
Izmir Katip Celebi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ejder Saylav BORA

Assoc. Prof. M.D. PhD

Izmir Katip Celebi University

研究点 (2)

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