Trial Outcomes & Findings for Automated Real-time Feedback on CPR Study (NCT NCT00539539)

Results Overview

Return of spontaneous circulation (ROSC)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1586 participants

Primary outcome timeframe

Prehospital resuscitation

Results posted on

2012-06-25

Participant Flow

Participant milestones

Participant milestones
Measure	Feedback On Automated real-time feedback on CPR Process activated	Feedback Off 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.
Overall Study STARTED	815	771
Overall Study COMPLETED	815	771
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Automated Real-time Feedback on CPR Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Feedback On n=815 Participants Automated real-time feedback on CPR Process activated	Feedback Off n=771 Participants 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.	Total n=1586 Participants Total of all reporting groups
Age Categorical <=18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Age Categorical Between 18 and 65 years	275 participants n=5 Participants	288 participants n=7 Participants	563 participants n=5 Participants
Age Categorical >=65 years	310 participants n=5 Participants	298 participants n=7 Participants	608 participants n=5 Participants
Age Continuous	65 years STANDARD_DEVIATION 17 • n=5 Participants	66 years STANDARD_DEVIATION 17 • n=7 Participants	66 years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	295 Participants n=5 Participants	291 Participants n=7 Participants	586 Participants n=5 Participants
Sex: Female, Male Male	520 Participants n=5 Participants	480 Participants n=7 Participants	1000 Participants n=5 Participants
Region of Enrollment United States	777 participants n=5 Participants	766 participants n=7 Participants	1543 participants n=5 Participants
Region of Enrollment Canada	38 participants n=5 Participants	5 participants n=7 Participants	43 participants n=5 Participants

PRIMARY outcome

Timeframe: Prehospital resuscitation

Population: Intent to treat

Return of spontaneous circulation (ROSC)

Outcome measures

Outcome measures
Measure	Feedback On n=815 Participants Automated real-time feedback on CPR Process activated	Feedback Off n=771 Participants 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.
Rate of ROSC During the Prehospital Resuscitation	361 Participants	345 Participants

SECONDARY outcome

Timeframe: Resuscitation

Population: Intention to treat. Presence of pulses not known for one participant on the feedback off arm. Analysis includes 815 participants on the feedback on arm and 770 on the feedback off arm.

Outcome measures

Outcome measures
Measure	Feedback On n=815 Participants Automated real-time feedback on CPR Process activated	Feedback Off n=771 Participants 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.
Pulses Present at ED Arrival.	260 Participants	243 Participants

SECONDARY outcome

Timeframe: Length of Hospitalization

Population: Intention to treat, with survival to hospital discharge missing for one participant on the feedback off arm. Analysis included 815 participants on the feedback on arm, and 770 on the feedback off arm.

Survival to hospital discharge