Effect of the Cardio First Angle Device on CPR Outcomes

NCT02394977 | Completed DMC

• 1 other identifier: BMSU-390-5-5904
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cardiopulmonary Arrest

Keywords

CPR; Cardio first angle; Clinical trial

Outcome Measures

Primary Outcomes (1)

• Sustained Return of Spontaneous Circulation

  ROSC lasting \> 30 minutes

  through resuscitation completion, an average of 30 to 60 minutes

Secondary Outcomes (5)

• Nurse Satisfaction Score

  upon resuscitation completion, an average of 30 to 60 minutes

• CPR Duration

  through resuscitation completion, an average of 30 to 60 minutes

• New post-resuscitation Sternum or Rib Fractures

  through resuscitation completion, an average of 30 to 60 minutes

• CPR Evaluation Score

  upon resuscitation completion, an average of 30 to 60 minutes

• CPR Guideline Observation Score

  upon resuscitation completion, an average of 30 to 60 minutes

Study Arms (2)

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.

Device: Compression with Feedback

Standard chest compression

ACTIVE COMPARATOR

CPR performed according to established international standards with standard manual chest compression

Other: Standard chest compression

Interventions

Compression with Feedback DEVICE

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.

Also known as: Cardio First Angel™

Compression with Feedback

Standard chest compression OTHER

CPR in accordance with published international guidelines using standard manual chest compression.

Standard chest compression

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Baqiyatallah Medical Sciences University: lead
• Shahid Beheshti University of Medical Sciences: collaborator
• West Virginia University: collaborator

Related Publications (1)

• 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.

  PMID: 27184664 RESULT

Related Links

• "Critical Care" site for full text

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Amir vahedian-azimi, PhD, RN

  BMSU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior intensivist nurse, Respiratory therapist, Research Fellow, PhD, RN, FCCS

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 20, 2015
• Study Start: January 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 5, 2018

Record last verified: 2018-07