Cardiopulmonary ArrestCFANCT02394977

Effect of the Cardio First Angle Device on CPR Outcomes

A study testing Compression with Feedback and Standard chest compression in people with Cardiopulmonary Arrest, run by Baqiyatallah Medical Sciences University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Cardiopulmonary Arrest
What is being tested?: Compression with Feedback and Standard chest compression
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: No sites listed yet
Study dates: Jan 2014to Dec 2014
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: Pilot Study of the Effect of Cardio First Angel (CFA) Device on CPR Outcomes:

The investigators conducted a randomized, controlled, single-blinded study of patients undergoing CPR for cardiac arrest in the mixed medical-surgical ICUs of four academic teaching hospitals in Tehran, Iran from June 1 to October 31, 2014. Patients were randomized to receive CPR with either standard manual compression, or compression with real-time audiovisual feedback using the Cardio First Angel™ device.

Read the detailed description

The investigators sought to determine if the addition of a CPR feedback device to routine manual CPR would impact the quality and consistency of chest compression and patient survival. We conducted a randomized, controlled, single-blinded study of patients undergoing CPR for cardiac arrest in the mixed medical-surgical ICUs of four academic teaching hospitals. Patients were randomized to receive either standard manual CPR or CPR using the Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) feedback device. Recorded variables included return of spontaneous circulation, adherence to CPR guidelines and quality of CPR, nurse satisfaction and CPR associated morbidity.

Conditions: Cardiopulmonary Arrest
Being tested: Compression with Feedback, Standard chest compression
Keywords: CPR, Cardio first angle, 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.

Compression with FeedbackDevice
Also called Cardio First Angel™
Patients in the intervention group received CPR in accordance to published guidelines using the CFA device per manufacturer instructions. The Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) is a lightweight device that consists of three components . Application of400 ± 30 Newtons of force (41 kg or 90 lb of pressure), which correlates toa sternum compression depth of 50-60 mm, is followed by an audible "click" sound to alert the rescuer to cease compression. The "click" sound is also audible upon spring decompression alerting the rescuer to resume compression. The device does not require an electrical power supply.
Standard chest compressionOther
CPR in accordance with published international guidelines using standard manual chest compression.

Study groups in NCT02394977
Study group	Role	What they receive
Compression with Feedback	Experimental	CPR performed according to established international standards with chest compressions performed with the assistance of the Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) compression feedback device. Receives: Device: Compression with Feedback
Standard chest compression	Active comparator	CPR performed according to established international standards with standard manual chest compression Receives: Other: Standard chest compression

What is being measured

The primary outcome is the main question the study is designed to answer.

Sustained Return of Spontaneous Circulation
ROSC lasting > 30 minutes
Measured: through resuscitation completion, an average of 30 to 60 minutes

Secondary outcomes (5)

Nurse Satisfaction Score
Nurse satisfaction with resuscitation event using a validated tool
Measured: upon resuscitation completion, an average of 30 to 60 minutes
CPR Duration
Duration of CPR event
Measured: through resuscitation completion, an average of 30 to 60 minutes
New post-resuscitation Sternum or Rib Fractures
New sternum or Rib Fractures diagnosed post-resuscitation using X-ray, CT scan, or by Autopsy
Measured: through resuscitation completion, an average of 30 to 60 minutes
CPR Evaluation Score
CPR evaluation score assess quality of CPR including chest compression sing a validated tool
Measured: upon resuscitation completion, an average of 30 to 60 minutes
CPR Guideline Observation Score
Assesses guideline adherence
Measured: upon resuscitation completion, an average of 30 to 60 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Dec 2014

First posted20 Mar 2015 (estimated)
Study startJan 2014
Primary completionOct 2014
Study completionDec 2014

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: Supportive care
Allocation: Randomised
Intervention model: Single group
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02394977
Sponsor's protocol ID: BMSU-390-5-5904
Acronym: CFA
Status last verified: Jul 2018
First submitted: 5 Mar 2015
Last updated: 5 Jul 2018
Results posted: No
Data monitoring committee: Yes

Publications

Vahedian-Azimi A, Hajiesmaeili M, Amirsavadkouhi A, Jamaati H, Izadi M, Madani SJ, Hashemian SM, Miller AC. Effect of the Cardio First Angel device on CPR indices: a randomized controlled clinical trial. Crit Care. 2016 May 17;20(1):147. doi: 10.1186/s13054-016-1296-3.
PubMed 27184664

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of the Effect of Cardio First Angel (CFA) Device on CPR Outcomes:
ClinicalTrials.gov ID: NCT02394977
Acronym / sponsor ID: CFA / BMSU-390-5-5904
Conditions: Cardiopulmonary Arrest
Keywords: CPR, Cardio first angle, Clinical trial
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
Collaborators: Shahid Beheshti University of Medical Sciences, West Virginia University
Study start: Jan 2014
Primary completion: Oct 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 20 Mar 2015 (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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Single group
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Compression with Feedback	Experimental	Device: Compression with FeedbackCPR performed according to established international standards with chest compressions performed with the assistance of the Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) compression feedback device.
Standard chest compression	Active comparator	Other: Standard chest compressionCPR performed according to established international standards 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
Compression with FeedbackAlso: Cardio First Angel™Patients in the intervention group received CPR in accordance to published guidelines using the CFA device per manufacturer instructions. The Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) is a lightweight device that consists of three components . Application of400 ± 30 Newtons of force (41 kg or 90 lb of pressure), which correlates toa sternum compression depth of 50-60 mm, is followed by an audible "click" sound to alert the rescuer to cease compression. The "click" sound is also audible upon spring decompression alerting the rescuer to resume compression. The device does not require an electrical power supply.	Device	Compression with Feedback
Standard chest compressionCPR in accordance with published international guidelines using standard manual chest compression.	Other	Standard chest compression

Primary outcome

Sustained Return of Spontaneous Circulation
Time frame: through resuscitation completion, an average of 30 to 60 minutes
ROSC lasting > 30 minutes

5 secondary outcomes

Nurse Satisfaction Score
Time frame: upon resuscitation completion, an average of 30 to 60 minutes
CPR Duration
Time frame: through resuscitation completion, an average of 30 to 60 minutes
New post-resuscitation Sternum or Rib Fractures
Time frame: through resuscitation completion, an average of 30 to 60 minutes
CPR Evaluation Score
Time frame: upon resuscitation completion, an average of 30 to 60 minutes
CPR Guideline Observation Score
Time frame: upon resuscitation completion, an average of 30 to 60 minutes

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 5 Jul 2018.
Results publication: PubMed 27184664Vahedian-Azimi A, Hajiesmaeili M, Amirsavadkouhi A, Jamaati H, Izadi M, Madani SJ, Hashemian SM, Miller AC. Effect of the Cardio First Angel device on CPR indices: a randomized controlled clinical trial. Crit Care. 2016 May 17;20(1):147. doi: 10.1186/s13054-016-1296-3.
"Critical Care" site for full textLink provided by the sponsor.

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Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
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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

BMSU

Questions about this trial

What is this clinical trial studying?

A study testing Compression with Feedback and Standard chest compression in people with Cardiopulmonary Arrest, 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 5 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: through resuscitation completion, an average of 30 to 60 minutes). 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 NCT02394977, 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 5 Jul 2018.