Optimal Ventilation for Cardiac Arrest

Purpose

Pediatric cardiac arrest is a life-threatening problem affecting >15,000 hospitalized children each year. Less than half of these children survive to hospital discharge, and neurologic morbidity is common among survivors. The objective of this study is to evaluate the effectiveness of the OPTI-VENT bundle to improve survival to discharge with favorable neurological outcome (Pediatric Cerebral Performance Category Score 1-2 or no change from baseline) among children receiving at least 1 minute of CPR.

Condition

  • Cardiac Arrest (CA)

Eligibility

Eligible Ages
Between 37 Weeks and 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Invasive airway in place at the start of CPR or airway placed within the first 5 minutes - Received at least 1 minute of CPR.

Exclusion Criteria

  • Lack of commitment to aggressive ICU therapies (e.g., CPR performed as part of end-of-life care. - Brain death determination prior to the CPR event. - Out-of-hospital cardiac arrest was the reason for initial admission to the hospital (known poor outcomes). - Supported by Veno-Arterial Extra Corporeal Membrane Oxygenation at the start of CPR

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Control 		Standard ICU resuscitation practices throughout study
  • Other: None - control
    Control - no intervention
Experimental
OPTI-VENT Bundle 		Provider Education: During a brief (<2 minute) bedside education, the educator will 1) review the CPR ventilation rate targets for age, and 2) ensure the provider has a cue card of current rate recommendations on his/her person. Compliance will be defined as performance of at least 30 trainings per unit per month. We will record provider discipline and time since last training as a surrogate of training spread. Educators will leverage these two-minute trainings to review the patient's current ventilator settings as an initial target during CPR to ensure adequate chest rise. Additionally, a focus on CPR ventilation rates will be integrated into resuscitation education or quality meetings for all disciplines. "Report cards" detailing unit-level performance will be generated by the study team for review during site monthly presentations. Point-of-Care Guidance: A metronome will be deployed to all cardiac arrests using a smart phone application.
  • Other: OPTI-VENT Bundle
    Provider Education: During a brief (<2 minute) bedside education, the educator will 1) review the CPR ventilation rate targets for age, and 2) ensure the provider has a cue card of current rate recommendations on his/her person. Compliance will be defined as performance of at least 30 trainings per unit per month. We will record provider discipline and time since last training as a surrogate of training spread. Educators will leverage these two-minute trainings to review the patient's current ventilator settings as an initial target during CPR to ensure adequate chest rise. Additionally, a focus on CPR ventilation rates will be integrated into resuscitation education or quality meetings for all disciplines. "Report cards" detailing unit-level performance will be generated by the study team for review during site monthly presentations. Point-of-Care Guidance: A metronome will be deployed to all cardiac arrests using a smart phone application.
Experimental
Site 5 		Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
  • Other: OPTI-VENT Bundle
    Provider Education: During a brief (<2 minute) bedside education, the educator will 1) review the CPR ventilation rate targets for age, and 2) ensure the provider has a cue card of current rate recommendations on his/her person. Compliance will be defined as performance of at least 30 trainings per unit per month. We will record provider discipline and time since last training as a surrogate of training spread. Educators will leverage these two-minute trainings to review the patient's current ventilator settings as an initial target during CPR to ensure adequate chest rise. Additionally, a focus on CPR ventilation rates will be integrated into resuscitation education or quality meetings for all disciplines. "Report cards" detailing unit-level performance will be generated by the study team for review during site monthly presentations. Point-of-Care Guidance: A metronome will be deployed to all cardiac arrests using a smart phone application.
  • Other: Transition
    There will be a 2-month transition period for study sites beginning study enrollment using standard ICU practices as they onboard to the study intervention.
  • Other: None - control
    Control - no intervention
Experimental
Site 6 		Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
  • Other: OPTI-VENT Bundle
    Provider Education: During a brief (<2 minute) bedside education, the educator will 1) review the CPR ventilation rate targets for age, and 2) ensure the provider has a cue card of current rate recommendations on his/her person. Compliance will be defined as performance of at least 30 trainings per unit per month. We will record provider discipline and time since last training as a surrogate of training spread. Educators will leverage these two-minute trainings to review the patient's current ventilator settings as an initial target during CPR to ensure adequate chest rise. Additionally, a focus on CPR ventilation rates will be integrated into resuscitation education or quality meetings for all disciplines. "Report cards" detailing unit-level performance will be generated by the study team for review during site monthly presentations. Point-of-Care Guidance: A metronome will be deployed to all cardiac arrests using a smart phone application.
  • Other: Transition
    There will be a 2-month transition period for study sites beginning study enrollment using standard ICU practices as they onboard to the study intervention.
  • Other: None - control
    Control - no intervention
Experimental
Site 7 		Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
  • Other: OPTI-VENT Bundle
    Provider Education: During a brief (<2 minute) bedside education, the educator will 1) review the CPR ventilation rate targets for age, and 2) ensure the provider has a cue card of current rate recommendations on his/her person. Compliance will be defined as performance of at least 30 trainings per unit per month. We will record provider discipline and time since last training as a surrogate of training spread. Educators will leverage these two-minute trainings to review the patient's current ventilator settings as an initial target during CPR to ensure adequate chest rise. Additionally, a focus on CPR ventilation rates will be integrated into resuscitation education or quality meetings for all disciplines. "Report cards" detailing unit-level performance will be generated by the study team for review during site monthly presentations. Point-of-Care Guidance: A metronome will be deployed to all cardiac arrests using a smart phone application.
  • Other: Transition
    There will be a 2-month transition period for study sites beginning study enrollment using standard ICU practices as they onboard to the study intervention.
  • Other: None - control
    Control - no intervention
Experimental
Site 8 		Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
  • Other: OPTI-VENT Bundle
    Provider Education: During a brief (<2 minute) bedside education, the educator will 1) review the CPR ventilation rate targets for age, and 2) ensure the provider has a cue card of current rate recommendations on his/her person. Compliance will be defined as performance of at least 30 trainings per unit per month. We will record provider discipline and time since last training as a surrogate of training spread. Educators will leverage these two-minute trainings to review the patient's current ventilator settings as an initial target during CPR to ensure adequate chest rise. Additionally, a focus on CPR ventilation rates will be integrated into resuscitation education or quality meetings for all disciplines. "Report cards" detailing unit-level performance will be generated by the study team for review during site monthly presentations. Point-of-Care Guidance: A metronome will be deployed to all cardiac arrests using a smart phone application.
  • Other: Transition
    There will be a 2-month transition period for study sites beginning study enrollment using standard ICU practices as they onboard to the study intervention.
  • Other: None - control
    Control - no intervention
Experimental
Site 9 		Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
  • Other: OPTI-VENT Bundle
    Provider Education: During a brief (<2 minute) bedside education, the educator will 1) review the CPR ventilation rate targets for age, and 2) ensure the provider has a cue card of current rate recommendations on his/her person. Compliance will be defined as performance of at least 30 trainings per unit per month. We will record provider discipline and time since last training as a surrogate of training spread. Educators will leverage these two-minute trainings to review the patient's current ventilator settings as an initial target during CPR to ensure adequate chest rise. Additionally, a focus on CPR ventilation rates will be integrated into resuscitation education or quality meetings for all disciplines. "Report cards" detailing unit-level performance will be generated by the study team for review during site monthly presentations. Point-of-Care Guidance: A metronome will be deployed to all cardiac arrests using a smart phone application.
  • Other: Transition
    There will be a 2-month transition period for study sites beginning study enrollment using standard ICU practices as they onboard to the study intervention.
  • Other: None - control
    Control - no intervention
Experimental
Site 10 		Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
  • Other: OPTI-VENT Bundle
    Provider Education: During a brief (<2 minute) bedside education, the educator will 1) review the CPR ventilation rate targets for age, and 2) ensure the provider has a cue card of current rate recommendations on his/her person. Compliance will be defined as performance of at least 30 trainings per unit per month. We will record provider discipline and time since last training as a surrogate of training spread. Educators will leverage these two-minute trainings to review the patient's current ventilator settings as an initial target during CPR to ensure adequate chest rise. Additionally, a focus on CPR ventilation rates will be integrated into resuscitation education or quality meetings for all disciplines. "Report cards" detailing unit-level performance will be generated by the study team for review during site monthly presentations. Point-of-Care Guidance: A metronome will be deployed to all cardiac arrests using a smart phone application.
  • Other: Transition
    There will be a 2-month transition period for study sites beginning study enrollment using standard ICU practices as they onboard to the study intervention.
  • Other: None - control
    Control - no intervention
Experimental
Site 11 		Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
  • Other: OPTI-VENT Bundle
    Provider Education: During a brief (<2 minute) bedside education, the educator will 1) review the CPR ventilation rate targets for age, and 2) ensure the provider has a cue card of current rate recommendations on his/her person. Compliance will be defined as performance of at least 30 trainings per unit per month. We will record provider discipline and time since last training as a surrogate of training spread. Educators will leverage these two-minute trainings to review the patient's current ventilator settings as an initial target during CPR to ensure adequate chest rise. Additionally, a focus on CPR ventilation rates will be integrated into resuscitation education or quality meetings for all disciplines. "Report cards" detailing unit-level performance will be generated by the study team for review during site monthly presentations. Point-of-Care Guidance: A metronome will be deployed to all cardiac arrests using a smart phone application.
  • Other: Transition
    There will be a 2-month transition period for study sites beginning study enrollment using standard ICU practices as they onboard to the study intervention.
  • Other: None - control
    Control - no intervention
Experimental
Site 12 		Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
  • Other: OPTI-VENT Bundle
    Provider Education: During a brief (<2 minute) bedside education, the educator will 1) review the CPR ventilation rate targets for age, and 2) ensure the provider has a cue card of current rate recommendations on his/her person. Compliance will be defined as performance of at least 30 trainings per unit per month. We will record provider discipline and time since last training as a surrogate of training spread. Educators will leverage these two-minute trainings to review the patient's current ventilator settings as an initial target during CPR to ensure adequate chest rise. Additionally, a focus on CPR ventilation rates will be integrated into resuscitation education or quality meetings for all disciplines. "Report cards" detailing unit-level performance will be generated by the study team for review during site monthly presentations. Point-of-Care Guidance: A metronome will be deployed to all cardiac arrests using a smart phone application.
  • Other: Transition
    There will be a 2-month transition period for study sites beginning study enrollment using standard ICU practices as they onboard to the study intervention.
  • Other: None - control
    Control - no intervention
Experimental
Site 13 		Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
  • Other: OPTI-VENT Bundle
    Provider Education: During a brief (<2 minute) bedside education, the educator will 1) review the CPR ventilation rate targets for age, and 2) ensure the provider has a cue card of current rate recommendations on his/her person. Compliance will be defined as performance of at least 30 trainings per unit per month. We will record provider discipline and time since last training as a surrogate of training spread. Educators will leverage these two-minute trainings to review the patient's current ventilator settings as an initial target during CPR to ensure adequate chest rise. Additionally, a focus on CPR ventilation rates will be integrated into resuscitation education or quality meetings for all disciplines. "Report cards" detailing unit-level performance will be generated by the study team for review during site monthly presentations. Point-of-Care Guidance: A metronome will be deployed to all cardiac arrests using a smart phone application.
  • Other: Transition
    There will be a 2-month transition period for study sites beginning study enrollment using standard ICU practices as they onboard to the study intervention.
  • Other: None - control
    Control - no intervention
Experimental
Site 14 		Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
  • Other: OPTI-VENT Bundle
    Provider Education: During a brief (<2 minute) bedside education, the educator will 1) review the CPR ventilation rate targets for age, and 2) ensure the provider has a cue card of current rate recommendations on his/her person. Compliance will be defined as performance of at least 30 trainings per unit per month. We will record provider discipline and time since last training as a surrogate of training spread. Educators will leverage these two-minute trainings to review the patient's current ventilator settings as an initial target during CPR to ensure adequate chest rise. Additionally, a focus on CPR ventilation rates will be integrated into resuscitation education or quality meetings for all disciplines. "Report cards" detailing unit-level performance will be generated by the study team for review during site monthly presentations. Point-of-Care Guidance: A metronome will be deployed to all cardiac arrests using a smart phone application.
  • Other: Transition
    There will be a 2-month transition period for study sites beginning study enrollment using standard ICU practices as they onboard to the study intervention.
  • Other: None - control
    Control - no intervention
Experimental
Site 15 		Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
  • Other: OPTI-VENT Bundle
    Provider Education: During a brief (<2 minute) bedside education, the educator will 1) review the CPR ventilation rate targets for age, and 2) ensure the provider has a cue card of current rate recommendations on his/her person. Compliance will be defined as performance of at least 30 trainings per unit per month. We will record provider discipline and time since last training as a surrogate of training spread. Educators will leverage these two-minute trainings to review the patient's current ventilator settings as an initial target during CPR to ensure adequate chest rise. Additionally, a focus on CPR ventilation rates will be integrated into resuscitation education or quality meetings for all disciplines. "Report cards" detailing unit-level performance will be generated by the study team for review during site monthly presentations. Point-of-Care Guidance: A metronome will be deployed to all cardiac arrests using a smart phone application.
  • Other: Transition
    There will be a 2-month transition period for study sites beginning study enrollment using standard ICU practices as they onboard to the study intervention.
  • Other: None - control
    Control - no intervention
Experimental
Site 16 		Study enrollment will begin on the control arm. There will be a 2-month transition period as they onboard to the intervention. And the remainder of the study period will be on the OPTI-VENT Bundle intervention.
  • Other: OPTI-VENT Bundle
    Provider Education: During a brief (<2 minute) bedside education, the educator will 1) review the CPR ventilation rate targets for age, and 2) ensure the provider has a cue card of current rate recommendations on his/her person. Compliance will be defined as performance of at least 30 trainings per unit per month. We will record provider discipline and time since last training as a surrogate of training spread. Educators will leverage these two-minute trainings to review the patient's current ventilator settings as an initial target during CPR to ensure adequate chest rise. Additionally, a focus on CPR ventilation rates will be integrated into resuscitation education or quality meetings for all disciplines. "Report cards" detailing unit-level performance will be generated by the study team for review during site monthly presentations. Point-of-Care Guidance: A metronome will be deployed to all cardiac arrests using a smart phone application.
  • Other: Transition
    There will be a 2-month transition period for study sites beginning study enrollment using standard ICU practices as they onboard to the study intervention.
  • Other: None - control
    Control - no intervention

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University in St. Louis
St Louis 4407066, Missouri 4398678 63110
Contact:
Stu Friess
314-286-2799
friess@wustl.edu

More Details

NCT ID
NCT07114510
Status
Recruiting
Sponsor
Children's Hospital of Philadelphia

Study Contact

CHOP RSC Clinical Research Program Manager
215-590-1859
grahamk1@chop.edu