Automated Real-time Feedback on CPR Study

Heart Arrest Clinical Trial

Official title:

Controlled Study of the Clinical Effectiveness of Automated Real-Time Feedback on CPR Process Conducted at a Subset of ROC Sites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00539539
• Other study ID #: 30707-A
• Secondary ID: 5U01HL077863-082
• Status: Completed
• Phase: Phase 2
• First received: October 2, 2007
• Last updated: May 21, 2012
• Start date: February 2007
• Est. completion date: September 2009

Study information

• Verified date: May 2012
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether or not real-time feedback on CPR process variables will increase rates of restoration of spontaneous circulation during prehospital resuscitation and upon arrival at the receiving emergency room as well as increase rates of survival to hospital discharge.

Description:

A subset of emergency medical services (EMS) agencies that are participating in the Resuscitation Outcomes Consortium (ROC) are adopting new monitor/defibrillators that are capable of monitoring CPR process during attempted resuscitation of patients in cardiac arrest, as well as providing automated real-time feedback about this process to EMS providers so as to improve compliance with recommended guidelines for CPR. Monitoring of CPR process during attempted resuscitation is an important step towards reducing the potential for poorly-performed CPR to modify the effect of the study interventions upon outcome. Clusters formed of rigs, an individual agency or groups of agencies were randomized to turn feedback on or off. After a fixed period of time, each cluster crossed over to the other arm. An unequal number of subjects were enrolled during each period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1586
• Est. completion date: September 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all individuals who experience cardiac arrest outside the hospital,

• are evaluated by organized EMS personnel and: a) receive attempts at external defibrillation (by lay responders or emergency personnel) or receive chest compressions by organized EMS personnel.

Exclusion Criteria:

• Use of a mechanical CPR device

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Arrest

Intervention

Other:
• Laerdal Q-CPR /technology
For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Thunder Bay	Ontario
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Washington	Seattle	Washington

Sponsors (5)

Lead Sponsor	Collaborator
University of Washington	Defence Research and Development Canada, National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS), The Institute of Circulatory and Respiratory Health (ICRH)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of ROSC During the Prehospital Resuscitation	Return of spontaneous circulation (ROSC)	Prehospital resuscitation	No
Secondary	Pulses Present at ED Arrival.		Resuscitation	No
Secondary	Survival to Hospital Discharge	Survival to hospital discharge	Length of Hospitalization	No
Secondary	CPR Fraction	Percentage of time during CPR spend doing compressions.	Up to 10 minutes of CPR	No
Secondary	Compression Depth	Average compression depth (mm) during the first 10 minutes of CPR.	Up to 10 minutes of CPR	No
Secondary	Compression Rate	Average compression rate during the first 10 minutes of CPR.	Up to 10 minutes of CPR	No
Secondary	Percentage of Compressions With an Incomplete Release	Percentage of compressions with incomplete release during the first ten minutes of CPR.	Up to 10 minutes of CPR	No
Secondary	Ventilation Rate	Average ventilation rate (breaths/minute) during the first ten minutes of CPR.	Up to 10 minutes of CPR	No

External Links

•   Click here for more information about this study: CPR Feedback Study