Automated Real-time Feedback on CPR Study

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT00539539
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH), National Institute of Neurological Disorders and Stroke (NINDS) (NIH), The Institute of Circulatory and Respiratory Health (ICRH) (Other), Defence Research and Development Canada (Industry)
• Enrollment: 1,586
• Locations: 3
• Arms: 2
• Duration (Months): 31
• Patients Per Site: 528.7
• Patients Per Site Per Month: 17.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Arrest	Other: Laerdal Q-CPR /technology	Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1586 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Controlled Study of the Clinical Effectiveness of Automated Real-Time Feedback on CPR Process Conducted at a Subset of ROC Sites
• Study Start Date: Feb 1, 2007
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Feedback On Automated real-time feedback on CPR Process activated	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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures

1. Rate of ROSC During the Prehospital Resuscitation [Prehospital resuscitation]

   Return of spontaneous circulation (ROSC)

Secondary Outcome Measures

1. Pulses Present at ED Arrival. [Resuscitation]

2. Survival to Hospital Discharge [Length of Hospitalization]

   Survival to hospital discharge

3. CPR Fraction [Up to 10 minutes of CPR]

   Percentage of time during CPR spend doing compressions.

4. Compression Depth [Up to 10 minutes of CPR]

   Average compression depth (mm) during the first 10 minutes of CPR.

5. Compression Rate [Up to 10 minutes of CPR]

   Average compression rate during the first 10 minutes of CPR.

6. Percentage of Compressions With an Incomplete Release [Up to 10 minutes of CPR]

   Percentage of compressions with incomplete release during the first ten minutes of CPR.

7. Ventilation Rate [Up to 10 minutes of CPR]

   Average ventilation rate (breaths/minute) during the first ten minutes of CPR.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
2	University of Washington	Seattle	Washington	United States	98199
3	The Ottawa Hospital	Thunder Bay	Ontario	Canada	K1Y 4E9

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Susanne May, PhD, University of Washington
• Study Director: Judy Powell, BSN, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Susanne May, Professor, University of Washington
• ClinicalTrials.gov Identifier: NCT00539539
• Other Study ID Numbers: 30707-A; 5U01HL077863-08; 28765
• First Posted: Oct 4, 2007
• Last Update Posted: Jun 25, 2012
• Last Verified: May 1, 2012

• Additional relevant MeSH terms: Heart Arrest

Study Results

Participant Flow

Arm/Group Title	Feedback On	Feedback Off
Arm/Group Description	Automated real-time feedback on CPR Process activated	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.
Period Title: Overall Study
STARTED	815	771
COMPLETED	815	771
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Feedback On	Feedback Off	Total
Arm/Group Description	Automated real-time feedback on CPR Process activated	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 of all reporting groups
Overall Participants	815	771	1586
Age (participants) [Number]
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	275 33.7%	288 37.4%	563 35.5%
>=65 years	310 38%	298 38.7%	608 38.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65 (17)	66 (17)	66 (17)
Sex: Female, Male (Count of Participants)
Female	295 36.2%	291 37.7%	586 36.9%
Male	520 63.8%	480 62.3%	1000 63.1%
Region of Enrollment (participants) [Number]
United States	777 95.3%	766 99.4%	1543 97.3%
Canada	38 4.7%	5 0.6%	43 2.7%

Outcome Measures

1. Primary Outcome

Title	Rate of ROSC During the Prehospital Resuscitation
Description	Return of spontaneous circulation (ROSC)
Time Frame	Prehospital resuscitation

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	Feedback On	Feedback Off
Arm/Group Description	Automated real-time feedback on CPR Process activated	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.
Measure Participants	815	771
Number [Participants]	361 44.3%	345 44.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Feedback On, Feedback Off
	Comments	Average change in cluster-specific rates of ROSC.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.96
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.001
	Confidence Interval	(2-Sided) 95%; -0.04 to 0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Pulses Present at ED Arrival.
Time Frame	Resuscitation

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Feedback On	Feedback Off
Arm/Group Description	Automated real-time feedback on CPR Process activated	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.
Measure Participants	815	771
Number [Participants]	260 31.9%	243 31.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Feedback On, Feedback Off
	Comments	Average difference in cluster-specific rates.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.71
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-0.8
	Confidence Interval	(2-Sided) 95%; -4.9 to 3.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Survival to Hospital Discharge
Description	Survival to hospital discharge
Time Frame	Length of Hospitalization

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Feedback On	Feedback Off
Arm/Group Description	Automated real-time feedback on CPR Process activated	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.
Measure Participants	815	771
Number [Participants]	92 11.3%	96 12.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Feedback On, Feedback Off
	Comments	Average change in cluster-specific risk difference.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.21
	Comments
	Method	t-test, 2 sided
	Comments	By-cluster difference in outcome rates.
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-0.015
	Confidence Interval	(2-Sided) 95%; -0.039 to 0.009
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	CPR Fraction
Description	Percentage of time during CPR spend doing compressions.
Time Frame	Up to 10 minutes of CPR

Outcome Measure Data

Analysis Population Description

Intention to treat, with CPR fraction available for 604 participants on the feedback on arm, and 570 on the feedback off arm.

Arm/Group Title	Feedback On	Feedback Off
Arm/Group Description	Automated real-time feedback on CPR Process activated	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.
Measure Participants	815	771
Mean (Standard Error) [Percentage]	66 (1)	64 (1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Feedback On, Feedback Off
	Comments	Cluster adjusted difference in average CPR fraction.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.016
	Comments
	Method	Regression, Linear
	Comments	Difference in means, adjusted for cluster.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; 0.4 to 3.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Compression Depth
Description	Average compression depth (mm) during the first 10 minutes of CPR.
Time Frame	Up to 10 minutes of CPR

Outcome Measure Data

Analysis Population Description

Intention to treat. Compression depth available for 529 participants on the feedback on arm and 467 on the feedback off arm.

Arm/Group Title	Feedback On	Feedback Off
Arm/Group Description	Automated real-time feedback on CPR Process activated	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.
Measure Participants	815	771
Mean (Standard Error) [mm]	39.6 (0.4)	37.8 (0.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Feedback On, Feedback Off
	Comments	Cluster adjusted difference in means.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	Regression, Linear
	Comments	Adjusted for randomization by cluster.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.6
	Confidence Interval	(2-Sided) 95%; 0.5 to 2.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Compression Rate
Description	Average compression rate during the first 10 minutes of CPR.
Time Frame	Up to 10 minutes of CPR

Outcome Measure Data

Analysis Population Description

Intention to treat. Average compression rate available for 604 participants on the feedback on arm and 570 on the feedback off arm.

Arm/Group Title	Feedback On	Feedback Off
Arm/Group Description	Automated real-time feedback on CPR Process activated	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.
Measure Participants	815	771
Mean (Standard Error) [Compressions per minute]	103.1 (0.5)	108.0 (0.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Feedback On, Feedback Off
	Comments	Cluster adjusted difference in average compression rate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.7
	Confidence Interval	(2-Sided) 95%; -6.4 to -3.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Percentage of Compressions With an Incomplete Release
Description	Percentage of compressions with incomplete release during the first ten minutes of CPR.
Time Frame	Up to 10 minutes of CPR

Outcome Measure Data

Analysis Population Description

Intention to treat. Incomplete release available for 529 participants on the feedback on arm and 467 on the feedback off arm.

Arm/Group Title	Feedback On	Feedback Off
Arm/Group Description	Automated real-time feedback on CPR Process activated	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.
Measure Participants	815	771
Mean (Standard Error) [% of compressions w/ incomplete release]	10.4 (1)	14.6 (1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Feedback On, Feedback Off
	Comments	Cluster adjusted difference in the average rate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-3.4
	Confidence Interval	(2-Sided) 95%; -5.2 to -1.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Ventilation Rate
Description	Average ventilation rate (breaths/minute) during the first ten minutes of CPR.
Time Frame	Up to 10 minutes of CPR

Outcome Measure Data

Analysis Population Description

Intention to treat. Ventilation rate available in 347 participants on the feedback on arm and 346 on the feedback off arm.

Arm/Group Title	Feedback On	Feedback Off
Arm/Group Description	Automated real-time feedback on CPR Process activated	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.
Measure Participants	815	771
Mean (Standard Error) [breaths per minute]	5.8 (0.2)	5.6 (0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Feedback On, Feedback Off
	Comments	Cluster adjusted difference in average rate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.73
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -0.5 to 0.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Pre-hospital resuscitation and hospitalization.
Arm/Group Title	Feedback On		Feedback Off
Arm/Group Description	Automated real-time feedback on CPR Process activated		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.
All Cause Mortality
	Feedback On		Feedback Off
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Feedback On		Feedback Off
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/815 (0%)		0/771 (0%)
Other (Not Including Serious) Adverse Events
	Feedback On		Feedback Off
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/815 (0%)		0/771 (0%)

Limitations/Caveats

Open label study - providers not blinded to intervention. High rates of missing CPR process measures.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.