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

December 23, 2025 updated by: Ejder Saylav BORA, Izmir Katip Celebi University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: CONTROL GROUP
GROUP WHICH LL BE APPLIED STANDARD CPR PROTOCOL OF AHA BUT WİTHOUT ELECTRİCALLY ISOLATED GLOVES
Active Comparator: INTERVENTION GROUP
HAND ON DEFIBRILLATION GROUP (WITH GLOVES)
Device: HANDS ON BUT OFF DEFIBRILLATION
GROUP WHICH LL BE APPLIED STANDARD CPR PROTOCOL OF AHA BY USING ELECTRICALLY ISOLATED GLOVES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MORTALITY RATE
Time Frame: 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.
UP TO 36 MONTHS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ROSC (return of spontaneous circulation) times
Time Frame: UP TO 36 MONTHS
At what time interval could ROSC be achieved with non-conductive gloves during CPR compared to the control group?
UP TO 36 MONTHS
End-tidal carbon dioxide (EtCO₂) response
Time Frame: UP TO 36 MONTHS
EtCO₂ levels during CPR with or without insulated gloves (mmHg)
UP TO 36 MONTHS
Its effect on post-CPR neurological outcomes will be evaluated
Time Frame: UP TO 36 MONTHS
post-CPR neurological outcomes with or without insulated gloves (modified ranking score (0-5)
UP TO 36 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Katip Celebi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2025

Primary Completion (Estimated)

October 6, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Estimated)

December 23, 2025

Study Record Updates

Last Update Posted (Actual)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 23, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IzmirKCU-EM-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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