Cardiopulmonary Resuscitation (CPR)IG-CPRNCT07299188
Effect of Electrically Insulated Gloves on ROSC Time, End-tidal CO₂ Response, Survival and Morbidity in Uninterrupted CPR
A study testing HANDS ON BUT OFF DEFIBRILLATION in people with Cardiopulmonary Resuscitation (CPR) and Electrical Shock, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Resuscitation (CPR), Electrical Shock, Defibrillation
- What is being tested?
- HANDS ON BUT OFF DEFIBRILLATION
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Nov 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- HANDS ON BUT OFF DEFIBRILLATION
- Keywords
- Cardiopulmonary resuscitation, electrically insulated composite gloves, Uninterrupted resuscitation during defibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HANDS ON BUT OFF DEFIBRILLATIONDevice
GROUP WHICH LL BE APPLIED STANDARD CPR PROTOCOL OF AHA BY USING ELECTRICALLY ISOLATED GLOVES
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: HANDS ON BUT OFF DEFIBRILLATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: UP TO 36 MONTHS
Secondary outcomes (3)
ROSC (return of spontaneous circulation) times
At what time interval could ROSC be achieved with non-conductive gloves during CPR compared to the control group?
Measured: UP TO 36 MONTHS
End-tidal carbon dioxide (EtCO₂) response
EtCO₂ levels during CPR with or without insulated gloves (mmHg)
Measured: UP TO 36 MONTHS
Its effect on post-CPR neurological outcomes will be evaluated
post-CPR neurological outcomes with or without insulated gloves (modified ranking score (0-5)
Measured: UP TO 36 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start6 Nov 2025
- Primary completion6 Oct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary Resuscitation (CPR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ejder Saylav BORA, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299188
- Sponsor's protocol ID
- IzmirKCU-EM-01
- Acronym
- IG-CPR
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40752672Deakin 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.
PubMed 23507464Musiari 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.
PubMed 34957226Deakin 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.
PubMed 25725295
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07299188
- Acronym / sponsor ID
- IG-CPR / IzmirKCU-EM-01
- Keywords
- Cardiopulmonary resuscitation, electrically insulated composite gloves, Uninterrupted resuscitation during defibrillation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- 6 Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | No intervention | –GROUP WHICH LL BE APPLIED STANDARD CPR PROTOCOL OF AHA BUT WİTHOUT ELECTRİCALLY ISOLATED GLOVES |
| INTERVENTION GROUP | Active comparator | Device: HANDS ON BUT OFF DEFIBRILLATIONHAND ON DEFIBRILLATION GROUP (WITH GLOVES) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Out-of-hospital cardiac arrests
- Patients who received CPR outside the emergency department
- Traumatic patients
- Pregnant patients
- Patients under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HANDS ON BUT OFF DEFIBRILLATIONGROUP WHICH LL BE APPLIED STANDARD CPR PROTOCOL OF AHA BY USING ELECTRICALLY ISOLATED GLOVES | Device | INTERVENTION GROUP |
Primary outcome
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.
3 secondary outcomes
ROSC (return of spontaneous circulation) times
Time frame: UP TO 36 MONTHS
End-tidal carbon dioxide (EtCO₂) response
Time frame: UP TO 36 MONTHS
Its effect on post-CPR neurological outcomes will be evaluated
Time frame: UP TO 36 MONTHS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Background: PubMed 40752672Jiang 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.
- Background: PubMed 23507464Deakin 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.
- Background: PubMed 34957226Musiari 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.
- Background: PubMed 25725295Deakin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HANDS ON BUT OFF DEFIBRILLATION in people with Cardiopulmonary Resuscitation (CPR) and Electrical Shock, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MORTALITY RATE (time frame: UP TO 36 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07299188, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.