NCT07299188

Effect of Electrically Insulated Gloves on ROSC Time, End-tidal CO₂ Response, Survival and Morbidity in Uninterrupted CPR

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Izmir Katip Celebi University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. This study aims to evaluate the effects of maintaining uninterrupted chest compressions even during defibrillation during CPR on ROSC time, EtCO₂ levels, short- and long-term survival rates, and morbidity, based on the results of a 3-year study. The findings obtained may contribute to optimizing clinical practice by more clearly demonstrating the importance of uninterrupted CPR in advanced life support algorithms.

Conditions

• Cardiopulmonary Resuscitation (CPR)
• Electrical Shock
• Defibrillation

Interventions

Type	Name	Description
DEVICE	HANDS ON BUT OFF DEFIBRILLATION	GROUP WHICH LL BE APPLIED STANDARD CPR PROTOCOL OF AHA BY USING ELECTRICALLY ISOLATED GLOVES

Timeline

• Start date: 2025-11-06
• Primary completion: 2028-10-06
• Completion: 2028-12-01
• First posted: 2025-12-23
• Last updated: 2025-12-30

Locations

1 site across 1 country: Turkey (Türkiye)