Pre-hospital Post ROSC Care: Are we Achieving Our Targets? (POP-ROC)

Which Patients With a ROSC After OHCA Would Potentially Benefit From Physician Driven Post Cardiac Arrest Care?

Rational: Out of hospital cardiac arrest is a devastating event with a high mortality. Survival rates have increased over the last years, with the availability of AED's and public BLS. Previous studies have shown that deranged physiology after return of spontaneous circulation (ROSC) is associated with a worse neurological outcome. Good quality post-arrest care is therefore of utmost importance.

Objective: To determine how often prehospital crews (with their given skills set) encounter problems meeting optimal post-ROSC targets in patients suffering from OHCA, and to investigate if this can be predicted based on patient-, provider- or treatment factors.

Study design: Prospective cohort study of all patients attended by the EMS services with an OHCA who regain ROSC and are transported to a single university hospital, in order to identify those patients with a ROSC after a non-traumatic OHCA who had deranged physiology and/or complications from OHCA EMS personnel was unable to prevent/deal with in the prehospital environment.

Study population: Patients, >18 years, transported by the EMS services to the ED of the University Hospital Groningen (UMCG) with a ROSC after OHCA in a 1 year period

Main study parameters/endpoints: Primary endpoint of our study is the percentage of OHCA patients with a prehospital ROSC who arrive in hospital with either a deranged physiology or with complications from OHCA EMS personnel was unable to deal with.

Study Overview

• Status: Unknown
• Conditions: Emergency Medical Services; Out-Of-Hospital Cardiac Arrest; Post Cardiac Arrest Syndrome

• Study Type: Observational
• Enrollment (Anticipated): 175

Contacts and Locations

• Study Contact: Name: Fabian Lucassen, drs; Phone Number: 0031-503614359; Email: f.g.lucassen@umcg.nl
• Study Contact Backup: Name: Ewoud ter Avest, dr; Phone Number: 0031-503614359; Email: e.ter.avest@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult (>18 years) patients with ROSC after OHCA transported to University Hospital Groningen by the EMS services.

Description

Inclusion criteria:

• Non-traumatic OHCA (as confirmed in notes of ambulance crew) with ROSC obtained before transport to hospital
• Age > 18

Exclusion criteria:

• Traumatic cause of arrest (NB asphyxia due to hanging, electrocutions and drowning are not considered as traumatic arrests in this study, as normal ALS algorithms (special circumstances) are followed for these patients
• No ROSC before leaving OHCA
• Age <18
• Informed opt out of medical research of patient

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of OHCA patients with a prehospital ROSC who arrive in hospital with either a deranged physiology or with complications from OHCA EMS personnel was unable to deal with	Any of the below 5 minutes or more after ROSC is obtained: -Airway intervention (SGA or ETT) not performed (when deemed necessary); Actively Vomiting in absence of ETT after ROSC B: -Hypoxia: -SaO2 <94% on at least two consecutive readings; Hypercarbia: -ETCO2>5.5 kPa on at least two consecutive readings** C: -Low cardiac output: -Re-arrest during transport to hospital; ETCO2<3.0 on two consecutive readings; MAP<65mmHg on two consecutive readings; SBP<100 mmHg on two consecutive readings upon arrival in ED D: -Hypoxic agitation upon arrival in ED or uncontrolled prehospital hypoxic agitation despite benzodiazepine administration or when benzodiazepines contraindicated); Seizures during transport E: -Hyperthermia	From pre-hospital ROSC to arrival at ED, approximately 1-2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of period with deranged physiology, measured from moment of first occurrence until resolved or until arrival in hospital.	Any of the following measured in minutes: -Airway intervention (SGA or ETT) not performed (when deemed necessary); Actively Vomiting in absence of ETT after ROSC B: -Hypoxia: -SaO2 <94% on at least two consecutive readings; Hypercarbia: -ETCO2>5.5 kPa on at least two consecutive readings** C: -Low cardiac output: -Re-arrest during transport to hospital; ETCO2<3.0 on two consecutive readings; MAP<65mmHg on two consecutive readings; SBP<100 mmHg on two consecutive readings upon arrival in ED D: -Hypoxic agitation upon arrival in ED or uncontrolled prehospital hypoxic agitation despite benzodiazepine administration or when benzodiazepines contraindicated); Seizures during transport E: -Hyperthermia	From pre-hospital ROSC to arrival at ED, approximately 1-2 hours
Patient- and resuscitation factors related to deranged physiology and/or complications in the post arrest phase		From pre-hospital ROSC to arrival at ED, approximately 1-2 hours
Opinion of EMS providers weather or not they felt they were able to provide optimal post arrest care	Measured by a survey, filled out by EMS crew at arrival at ED	From pre-hospital ROSC to arrival at emergency department, approximately 1-2 hours
Comparison of primary outcome of secondary outcomes between post ROSC patients attended by EMS only vs EMS and HEMS		From pre-hospital ROSC to arrival at emergency department, approximately 1-2 hours
Frequency distribution of airway interventions (SGA or ETT) not performed (when deemed necessary)	-Airway intervention (SGA or ETT) not performed (when deemed necessary) in ED. NB NOT change of SGA for ETT when SGA is functioning well	From pre-hospital ROSC to arrival at emergency department, approximately 1-2 hours
Frequency distribution of actively vomiting in absence of ETT after ROSC in prehospital setting		From pre-hospital ROSC to arrival at ED, approximately 1 to 2 hours
Frequency distribution of the presence of hypoxia	SaO2 <94% on at least two consecutive readings	From pre-hospital ROSC to arrival at ED, approximately 1 to 2 hours
Frequency distribution of low cardiac output	Presence of one of the following: Re-arrest during transport to hospital; ETCO2<3.0 on two consecutive readings; MAP<65mmHg on two consecutive readings 12; SBP<100 mmHg on two consecutive readings	From pre-hospital ROSC to ICU (or CCU) admission, up to about 1 hours
Frequency distribution of hypoxic agitation upon arrival in ED or uncontrolled prehospital hypoxic agitation despite benzodiazepine administration or when benzodiazepines contraindicated)	Assessed by physician who enrolls patient	From pre-hospital ROSC to arrival at ED, approximately 1-2 hours
Frequency distribution of seizures during transport		From pre-hospital ROSC to arrival at ED, approximately 1-2 hours
Frequency distribution of the presence of hyperthermia	Defined as a temperature >37.5 celsius	From pre-hospital ROSC to arrival at ED, approximately 1-2 hours

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Ewoud ter Avest, dr, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: April 5, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Actual): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 1, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Postoperative Complications; Disease Attributes; Brain Injuries; Reperfusion Injury; Emergencies; Heart Arrest; Out-of-Hospital Cardiac Arrest; Post-Cardiac Arrest Syndrome
• Other Study ID Numbers: 201900756

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No