ResuscitationNCT06280118
The Effect of Fatigue on CPR
A study testing Fatigue in people with Resuscitation, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
Trial summary
Background: This study, in contrast to the previous studies, generated a scenario of fatigue in an earthquake scenario and aimed to measure the effect of fatigue on the quality of cardiopulmonary resuscitation (CPR) performed by paramedics in a debris course. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Resuscitation
- What is being tested?
- Fatigue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2023to 25 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a paramedic student.
- Having taken a resuscitation course.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Resuscitation simulation laboratory of Artvin Çoruh University Health Services Vocational School
Artvin, 08000
About this study
Official title: The Effect of Fatigue Caused by Search and Rescue Efforts in the Debris on the Quality of Cardiopulmonary Resuscitation: A Randomized Controlled Trial
Background: This study, in contrast to the previous studies, generated a scenario of fatigue in an earthquake scenario and aimed to measure the effect of fatigue on the quality of cardiopulmonary resuscitation (CPR) performed by paramedics in a debris course.
Methods: The study was designed as a randomized controlled trial. The sample, consisting of 84 paramedic students, was randomly assigned as 42 control and 42 experimental groups. Fatigue was created in the participants by rehearsing the process of removing and transporting earthquake victims from the rubble through the prepared track. A personal information form and a CPR measurement form were used to obtain the data. The simulator was used to evaluate the accuracy of CPR. The collected data were analysed with the statistical program.
Read the detailed description
Introduction Cardiopulmonary Arrest (CPA) is among the leading cause of death worldwide. Each year, 375,000 people are reported to die in Europe and 250,000 in the United States due to CPA. Early diagnosis of arrest and Cardiopulmonary Resuscitation is life-saving. However, earthquakes, one of the deadliest disasters, are among the most challenging situations that people around the world have to face. The rate of rescue of survivors from earthquake or collapsed structures is reported to decrease by 50% following 24 hours. Therefore, the first 72 hours are crucial for search and rescue operations in disasters. In earthquakes, while some of the disaster victims experience arrest at the scene due to trauma, others experience arrest in early or late periods depending on the injury site and localization. Thus, search and rescue operations should be initiated quickly, effectively and swiftly in disaster areas. Properly and efficiently administered CPR is among the most crucial life-saving emergency medical care methods. In Turkey, paramedics are also deployed to National Medical Rescue Team (NMRT) units to support search and rescue activities and provide emergency medical care. Paramedics have difficulties in maintaining chest compressions in arrest cases, especially in challenging cases in tight spaces outside the hospital. Since chest compressions are considered the essential element of CPR, their quality is thought to be affected under harsh conditions. 2015 International Liaison Committee on Resuscitation (ILCOR) recommended the compression depth as 5-6 cm and stated that 1/3 of the sternum should be compressed owing to the body mass differences of the rescuers. However, effective CPR depends on many parameters such as the number of rescuers, elapsed time, physical characteristics and muscle strength of the rescuer, high level of fitness, fatigue, weight of the rescuer, physical fitness, having a higher maximum oxygen consumption, position of the rescuer, difficult and confined space rescues. This study aimed in this context, to measure the effects of fatigue on CPR using high-quality simulators.
- Conditions
- Resuscitation
- Being tested
- Fatigue
- Keywords
- Earthquake, debris, compression, ventilation, fatigue
- Medical subject headings
- Respiratory Aspiration, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FatigueOther
Fatigue was created in the participants by rehearsing the process of removing and transporting earthquake victims from the rubble through the prepared track.
| Study group | Role | What they receive |
|---|---|---|
| Pre-test (Control group) | No intervention | Not described |
| Post test (Control group) | No intervention | Not described |
| Pre test (experimental group) | No intervention | Not described |
| Post test (experimental group) | Experimental | Not described Receives: Other: Fatigue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct number of ventilations
The number of ventilations applied correctly will be measured in the pre-test and post-tests.
Measured: 120 second
Correct number of compression
The number of compressions applied in the correct way will be measured in the pre-test and post-test.
Measured: 120 second
Secondary outcomes (1)
CPR duration
CPR times applied in the pre-test and post-test will be measured.
Measured: 120 second
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start20 Apr 2023
- Primary completion20 Jun 2023
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ResuscitationStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artvin Coruh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadir Cavus, Artvin Coruh University
- Investigators
- Oğuzhan Tiryaki, Expert Nursing, Principal investigator, Artvin State HospitalElif Tiryaki, Lecturer, Principal investigator, Artvin Çoruh UniversitySuat Çelik, Lecturer, Principal investigator, Artvin Çoruh UniversityHüseyin Bora Saçar, Lecturer, Principal investigator, Artvin Çoruh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280118
- Sponsor's protocol ID
- EFCPR008
- Status last verified
- Feb 2024
- First submitted
- 26 Jan 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pan DF, Li ZJ, Ji XZ, Yang LT, Liang PF. Video-assisted bystander cardiopulmonary resuscitation improves the quality of chest compressions during simulated cardiac arrests: A systemic review and meta-analysis. World J Clin Cases. 2022 Nov 6;10(31):11442-11453. doi: 10.12998/wjcc.v10.i31.11442.
PubMed 36387811Kleinman ME, Brennan EE, Goldberger ZD, Swor RA, Terry M, Bobrow BJ, Gazmuri RJ, Travers AH, Rea T. Part 5: Adult Basic Life Support and Cardiopulmonary Resuscitation Quality: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S414-35. doi: 10.1161/CIR.0000000000000259. No abstract available.
PubMed 26472993
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fatigue Caused by Search and Rescue Efforts in the Debris on the Quality of Cardiopulmonary Resuscitation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06280118
- Acronym / sponsor ID
- EFCPR008
- Conditions
- Resuscitation
- Keywords
- Earthquake, debris, compression, ventilation, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Artvin Coruh UniversityUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 28 Feb 2024 (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.
Background: This study, in contrast to the previous studies, generated a scenario of fatigue in an earthquake scenario and aimed to measure the effect of fatigue on the quality of cardiopulmonary resuscitation (CPR) performed by paramedics in a debris course.
Methods: The study was designed as a randomized controlled trial. The sample, consisting of 84 paramedic students, was randomly assigned as 42 control and 42 experimental groups. Fatigue was created in the participants by rehearsing the process of removing and transporting earthquake victims from the rubble through the prepared track. A personal information form and a CPR measurement form were used to obtain the data. The simulator was used to evaluate the accuracy of CPR. The collected data were analysed with the statistical program.
Detailed description
Introduction Cardiopulmonary Arrest (CPA) is among the leading cause of death worldwide. Each year, 375,000 people are reported to die in Europe and 250,000 in the United States due to CPA. Early diagnosis of arrest and Cardiopulmonary Resuscitation is life-saving. However, earthquakes, one of the deadliest disasters, are among the most challenging situations that people around the world have to face. The rate of rescue of survivors from earthquake or collapsed structures is reported to decrease by 50% following 24 hours. Therefore, the first 72 hours are crucial for search and rescue operations in disasters. In earthquakes, while some of the disaster victims experience arrest at the scene due to trauma, others experience arrest in early or late periods depending on the injury site and localization. Thus, search and rescue operations should be initiated quickly, effectively and swiftly in disaster areas. Properly and efficiently administered CPR is among the most crucial life-saving emergency medical care methods. In Turkey, paramedics are also deployed to National Medical Rescue Team (NMRT) units to support search and rescue activities and provide emergency medical care. Paramedics have difficulties in maintaining chest compressions in arrest cases, especially in challenging cases in tight spaces outside the hospital. Since chest compressions are considered the essential element of CPR, their quality is thought to be affected under harsh conditions. 2015 International Liaison Committee on Resuscitation (ILCOR) recommended the compression depth as 5-6 cm and stated that 1/3 of the sternum should be compressed owing to the body mass differences of the rescuers. However, effective CPR depends on many parameters such as the number of rescuers, elapsed time, physical characteristics and muscle strength of the rescuer, high level of fitness, fatigue, weight of the rescuer, physical fitness, having a higher maximum oxygen consumption, position of the rescuer, difficult and confined space rescues. This study aimed in this context, to measure the effects of fatigue on CPR using high-quality simulators.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Pre-test (Control group) | No intervention | – |
| Post test (Control group) | No intervention | – |
| Pre test (experimental group) | No intervention | – |
| Post test (experimental group) | Experimental | Other: Fatigue |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Being a paramedic student.
- Having taken a resuscitation course.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| FatigueFatigue was created in the participants by rehearsing the process of removing and transporting earthquake victims from the rubble through the prepared track. | Other | Post test (experimental group) |
Primary outcome
Correct number of ventilations
Time frame: 120 second
The number of ventilations applied correctly will be measured in the pre-test and post-tests.
Correct number of compression
Time frame: 120 second
The number of compressions applied in the correct way will be measured in the pre-test and post-test.
1 secondary outcome
CPR duration
Time frame: 120 second
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 36387811Pan DF, Li ZJ, Ji XZ, Yang LT, Liang PF. Video-assisted bystander cardiopulmonary resuscitation improves the quality of chest compressions during simulated cardiac arrests: A systemic review and meta-analysis. World J Clin Cases. 2022 Nov 6;10(31):11442-11453. doi: 10.12998/wjcc.v10.i31.11442.
- Background: PubMed 26472993Kleinman ME, Brennan EE, Goldberger ZD, Swor RA, Terry M, Bobrow BJ, Gazmuri RJ, Travers AH, Rea T. Part 5: Adult Basic Life Support and Cardiopulmonary Resuscitation Quality: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S414-35. doi: 10.1161/CIR.0000000000000259. No abstract available.
- 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.
Oğuzhan Tiryaki, Expert Nursing principal investigator
Artvin State Hospital
Elif Tiryaki, Lecturer principal investigator
Artvin Çoruh University
Suat Çelik, Lecturer principal investigator
Artvin Çoruh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatigue in people with Resuscitation, run by Artvin Coruh 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 28 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correct number of ventilations (time frame: 120 second). The study lists 2 primary outcomes in all. 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 NCT06280118, which also lists 2 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 28 Feb 2024.