Effect of Electrically Insulated Gloves on ROSC Time, End-tidal CO₂ Response, Survival and Morbidity in Uninterrupted CPR
NCT ID: NCT07299188
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
32 participants
INTERVENTIONAL
2025-11-06
2028-12-31
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
A total of 32 patients who have suffered cardiac arrest in the emergency department and whose initial rhythm is shockable (ventricular fibrillation or pulseless ventricular tachycardia) will be included in the study. Patients will be divided into two groups: an experimental group (n=16) receiving uninterrupted CPR protocol and a control group (n=16) receiving standard CPR.
SUPPORTIVE_CARE
NONE
Study Groups
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CONTROL GROUP
GROUP WHICH LL BE APPLIED STANDARD CPR PROTOCOL OF AHA BUT WİTHOUT ELECTRİCALLY ISOLATED GLOVES
No interventions assigned to this group
INTERVENTION GROUP
HAND ON DEFIBRILLATION GROUP (WITH GLOVES)
HANDS ON BUT OFF DEFIBRILLATION
GROUP WHICH LL BE APPLIED STANDARD CPR PROTOCOL OF AHA BY USING ELECTRICALLY ISOLATED GLOVES
Interventions
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HANDS ON BUT OFF DEFIBRILLATION
GROUP WHICH LL BE APPLIED STANDARD CPR PROTOCOL OF AHA BY USING ELECTRICALLY ISOLATED GLOVES
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Patients who received CPR outside the emergency department
* Traumatic patients
* Pregnant patients
* Patients under 18 years of age
* Terminally ill patients
18 Years
ALL
No
Sponsors
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Izmir Katip Celebi University
OTHER
Responsible Party
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Ejder Saylav BORA
Assoc. Prof. M.D. PhD
Locations
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Izmir Katip Çelebi University
Izmir, , Turkey (Türkiye)
Countries
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References
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Jiang T, Sun Y, Zhang H, Zhang Q, Tang S, Niu X, Guo Y, Li K, Chen Y, Xu F. Combined end-tidal CO2 and diastolic blood pressure-guided CPR improves survival from cardiac arrest in porcine model. Resuscitation. 2025 Nov;216:110745. doi: 10.1016/j.resuscitation.2025.110745. Epub 2025 Aug 5.
Deakin CD, Lee-Shrewsbury V, Hogg K, Petley GW. Do clinical examination gloves provide adequate electrical insulation for safe hands-on defibrillation? I: Resistive properties of nitrile gloves. Resuscitation. 2013 Jul;84(7):895-9. doi: 10.1016/j.resuscitation.2013.03.011. Epub 2013 Mar 16.
Musiari M, Saporito A, Ceruti S, Biggiogero M, Iattoni M, Glotta A, Cantini L, Capdevila X, Cassina T. Can a Glove-Coach Technology Significantly Increase the Efficacy of Cardiopulmonary Resuscitation on Non-healthcare Professionals? A Controlled Trial. Front Cardiovasc Med. 2021 Dec 9;8:685988. doi: 10.3389/fcvm.2021.685988. eCollection 2021.
Deakin CD, Thomsen JE, Lofgren B, Petley GW. Achieving safe hands-on defibrillation using electrical safety gloves--a clinical evaluation. Resuscitation. 2015 May;90:163-7. doi: 10.1016/j.resuscitation.2014.12.028. Epub 2015 Feb 26.
Other Identifiers
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IzmirKCU-EM-01
Identifier Type: -
Identifier Source: org_study_id