Cardiopulmonary ArrestCFANCT02845011
Compression Feedback for Patients With In-hospital Cardiac Arrest
A study testing Audiovisual compression feedback and Standard Manual Chest Compression in people with Cardiopulmonary Arrest and Cardiopulmonary Resuscitation, run by Baqiyatallah Medical Sciences University.
Trial summary
A prospective, randomized, controlled, parallel study was conducted in patients undergoing resuscitation with chest compression for in-hospital cardiac arrest (IHCA) in the mixed medical-surgical ICU's of 8 academic tertiary care hospitals in Iran. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiopulmonary Arrest, Cardiopulmonary Resuscitation
- What is being tested?
- Audiovisual compression feedback and Standard Manual Chest Compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 Dec 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Admitted to the intensive care unit (ICU)
- Full-code status
- Informed consent was obtained from the patient, legal guardian, or healthcare surrogate upon ICU admission (prior to cardiac arrest event)
Who cannot join
- Patients with any limitation of code status including but not limited to "no code" or"do not resuscitate" (DNR) and"do not intubate" (DNI), were excluded from study participation
About this study
Official title: Real-time Compression Feedback for Patients With In-hospital Cardiac Arrest: A Multi-Center Randomized Controlled Clinical Trial
A prospective, randomized, controlled, parallel study was conducted in patients undergoing resuscitation with chest compression for in-hospital cardiac arrest (IHCA) in the mixed medical-surgical ICU's of 8 academic tertiary care hospitals in Iran. Patients randomized into 2 groups: 1) standard chest compression, 2) chest compression with real-time audio-visual feedback using the Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) device. The primary outcome was sustained return of spontaneous circulation (ROSC). Secondary outcomes were survival to ICU and hospital discharge, incidence of sternum and rib fractures.
Read the detailed description
A prospective, randomized, controlled, parallel study was conducted in patients undergoing resuscitation with chest compression for in-hospital cardiac arrest (IHCA) in the mixed medical-surgical ICU's of 8 academic tertiary care hospitals in Iran. Patients randomized into 2 groups: 1) standard chest compression, 2) chest compression with real-time audio-visual feedback using the Cardio First Angel™ (INOTECH, Nubberg, Germany) device. Randomization accomplished using Random Allocation Software© (RAS; Informer Technologies, Inc., Madrid, Spain). Crossover was not allowed. The patient and data analyzer were blinded. The clinical provider was not blinded. The primary outcome was sustained return of spontaneous circulation (ROSC). Secondary outcomes were survival to ICU and hospital discharge, incidence of sternum and rib fractures.
- Being tested
- Audiovisual compression feedback, Standard Manual Chest Compression
- Keywords
- Cardio first angle, CPR, Cardiopulmonary Arrest, Clinical trial
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiovisual compression feedbackDevice
Also called Cardio First Angel™
The Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) is a handheld device consisting of three components. The rescuer-side has a red palm-sized push-button with a pictogram illustrating proper use. The center unit is composed of a stable plastic base containing an arrangement of springs, and the patient-side consists of liquid-absorbent polyurethane foam. Application of 400 ± 30 Newtons of force results in an audible click alerting the rescuer to cease compression, and an additional click on decompression alerts the rescuer to resume compression.
Standard Manual Chest CompressionOther
Cardiopulmonary resuscitation according to published international guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Audiovisual compression feedback | Experimental | Cardiopulmonary resuscitation according to international guidelines with chest compressions performed with real-time audiovisual feedback using the Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) device. Receives: Device: Audiovisual compression feedback |
| Standard chest compression | Active comparator | Cardiopulmonary resuscitation according to international guidelines with standard manual chest compression Receives: Other: Standard Manual Chest Compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Return of Spontaneous Circulation
Return of spontaneous circulation
Measured: 30 minutes after completion of cardiopulmonary resuscitation
Secondary outcomes (3)
Survival to ICU discharge
Survival to first or only ICU discharge
Measured: through ICU discharge, usually 15-35 days
Survival to Hospital Discharge
Survival to Hospital Discharge
Measured: through study completion, usually 30-45 days
Fractures
Number of rib or sternum fractures
Measured: through study completion, usually less than 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study start1 Jan 2015
- Primary completion15 Sep 2015
- Study completion30 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary ArrestStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baqiyatallah Medical Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University, Tehran University of Medical Sciences, East Carolina University
- Responsible party
- Principal investigator, Amir Vahedian-Azimi, Baqiyatallah Medical Sciences University
- Investigators
- Amir Vahedian-azimi, PhD, RN, Principal investigator, Baqiyatallah Universiy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845011
- Sponsor's protocol ID
- BMSU CFA Prospective
- Acronym
- CFA
- Status last verified
- Jul 2018
- First submitted
- 21 Jul 2016
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Goharani R, Vahedian-Azimi A, Farzanegan B, Bashar FR, Hajiesmaeili M, Shojaei S, Madani SJ, Gohari-Moghaddam K, Hatamian S, Mosavinasab SMM, Khoshfetrat M, Khabiri Khatir MA, Miller AC; MORZAK Collaborative. Real-time compression feedback for patients with in-hospital cardiac arrest: a multi-center randomized controlled clinical trial. J Intensive Care. 2019 Jan 22;7:5. doi: 10.1186/s40560-019-0357-5. eCollection 2019.
PubMed 30693086
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Compression Feedback for Patients With In-hospital Cardiac Arrest: A Multi-Center Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02845011
- Acronym / sponsor ID
- CFA / BMSU CFA Prospective
- Keywords
- Cardio first angle, CPR, Cardiopulmonary Arrest, Clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
- Collaborators
- Shahid Beheshti University, Tehran University of Medical Sciences, East Carolina University
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 15 Sep 2015 (actual)
- Study completion
- 30 Dec 2015 (actual)
- First posted
- 26 Jul 2016 (estimated)
- 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.
A prospective, randomized, controlled, parallel study was conducted in patients undergoing resuscitation with chest compression for in-hospital cardiac arrest (IHCA) in the mixed medical-surgical ICU's of 8 academic tertiary care hospitals in Iran. Patients randomized into 2 groups: 1) standard chest compression, 2) chest compression with real-time audio-visual feedback using the Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) device. The primary outcome was sustained return of spontaneous circulation (ROSC). Secondary outcomes were survival to ICU and hospital discharge, incidence of sternum and rib fractures.
Detailed description
A prospective, randomized, controlled, parallel study was conducted in patients undergoing resuscitation with chest compression for in-hospital cardiac arrest (IHCA) in the mixed medical-surgical ICU's of 8 academic tertiary care hospitals in Iran. Patients randomized into 2 groups: 1) standard chest compression, 2) chest compression with real-time audio-visual feedback using the Cardio First Angel™ (INOTECH, Nubberg, Germany) device. Randomization accomplished using Random Allocation Software© (RAS; Informer Technologies, Inc., Madrid, Spain). Crossover was not allowed. The patient and data analyzer were blinded. The clinical provider was not blinded. The primary outcome was sustained return of spontaneous circulation (ROSC). Secondary outcomes were survival to ICU and hospital discharge, incidence of sternum and rib fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Audiovisual compression feedback | Experimental | Device: Audiovisual compression feedbackCardiopulmonary resuscitation according to international guidelines with chest compressions performed with real-time audiovisual feedback using the Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) device. |
| Standard chest compression | Active comparator | Other: Standard Manual Chest CompressionCardiopulmonary resuscitation according to international guidelines with standard manual chest compression |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Admitted to the intensive care unit (ICU)
- Full-code status
- Informed consent was obtained from the patient, legal guardian, or healthcare surrogate upon ICU admission (prior to cardiac arrest event)
Key exclusion criteria (1 listed)
- Patients with any limitation of code status including but not limited to "no code" or"do not resuscitate" (DNR) and"do not intubate" (DNI), were excluded from study participation
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 |
|---|---|---|
| Audiovisual compression feedbackAlso: Cardio First Angel™The Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) is a handheld device consisting of three components. The rescuer-side has a red palm-sized push-button with a pictogram illustrating proper use. The center unit is composed of a stable plastic base containing an arrangement of springs, and the patient-side consists of liquid-absorbent polyurethane foam. Application of 400 ± 30 Newtons of force results in an audible click alerting the rescuer to cease compression, and an additional click on decompression alerts the rescuer to resume compression. | Device | Audiovisual compression feedback |
| Standard Manual Chest CompressionCardiopulmonary resuscitation according to published international guidelines. | Other | Standard chest compression |
Primary outcome
Sustained Return of Spontaneous Circulation
Time frame: 30 minutes after completion of cardiopulmonary resuscitation
Return of spontaneous circulation
3 secondary outcomes
Survival to ICU discharge
Time frame: through ICU discharge, usually 15-35 days
Survival to Hospital Discharge
Time frame: through study completion, usually 30-45 days
Fractures
Time frame: through study completion, usually less than 60 days
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 6 Jul 2018.
- Derived from this study: PubMed 30693086Goharani R, Vahedian-Azimi A, Farzanegan B, Bashar FR, Hajiesmaeili M, Shojaei S, Madani SJ, Gohari-Moghaddam K, Hatamian S, Mosavinasab SMM, Khoshfetrat M, Khabiri Khatir MA, Miller AC; MORZAK Collaborative. Real-time compression feedback for patients with in-hospital cardiac arrest: a multi-center randomized controlled clinical trial. J Intensive Care. 2019 Jan 22;7:5. doi: 10.1186/s40560-019-0357-5. eCollection 2019.
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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.
Amir Vahedian-azimi, PhD, RN principal investigator
Baqiyatallah Universiy of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Audiovisual compression feedback and Standard Manual Chest Compression in people with Cardiopulmonary Arrest and Cardiopulmonary Resuscitation, run by Baqiyatallah Medical Sciences University.
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 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 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Sustained Return of Spontaneous Circulation (time frame: 30 minutes after completion of cardiopulmonary resuscitation). 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 NCT02845011, which also lists 1 linked publication.
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 6 Jul 2018.