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

NCT07299188 | Active Not Recruiting

• 1 other identifier: IzmirKCU-EM-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Defibrillation; Cardiopulmonary Resuscitation (CPR); Electrical Shock

Keywords

Cardiopulmonary resuscitation; electrically insulated composite gloves; Uninterrupted resuscitation during defibrillation

Outcome Measures

Primary Outcomes (1)

• MORTALITY RATE

  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 Outcomes (3)

• 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

Study Arms (2)

CONTROL GROUP

NO INTERVENTION

GROUP WHICH LL BE APPLIED STANDARD CPR PROTOCOL OF AHA BUT WİTHOUT ELECTRİCALLY ISOLATED GLOVES

INTERVENTION GROUP

ACTIVE COMPARATOR

HAND ON DEFIBRILLATION GROUP (WITH GLOVES)

Device: HANDS ON BUT OFF DEFIBRILLATION

Interventions

HANDS ON BUT OFF DEFIBRILLATION DEVICE

GROUP WHICH LL BE APPLIED STANDARD CPR PROTOCOL OF AHA BY USING ELECTRICALLY ISOLATED GLOVES

INTERVENTION GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Çelebi University

Izmir, 35000, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 40752672 BACKGROUND

• 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.

  PMID: 23507464 BACKGROUND

• 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.

  PMID: 34957226 BACKGROUND

• 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.

  PMID: 25725295 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. M.D. PhD

Model Details: EN 60903:2003 and IEC 60903:2014 compliant, Class 2 (17,000 V AC) electrically insulated composite Starline Linepro insulation gloves will be used. These gloves were chosen because they offer advantages to the rescuer in terms of high insulation capacity, flexible structure, and maneuverability during CPR. With the use of these gloves, the rescuer will be able to continue chest compressions without interruption during defibrillation, without breaking physical contact with the patient. This application will be evaluated in terms of both electrical safety and resuscitation quality. 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.

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 23, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): October 6, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)