Clinical trial NCT04339257: Pre-hospital Post ROSC Care: Are we Achieving Our Targets?
Official title: Which Patients With a ROSC After OHCA Would Potentially Benefit From Physician Driven Post Cardiac Arrest Care?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Out-Of-Hospital Cardiac Arrest
Post Cardiac Arrest Syndrome
Emergency Medical Services
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (\>18 years) patients with ROSC after OHCA transported to University Hospital Groningen by the EMS services.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: From pre-hospital ROSC to arrival at ED, approximately 1-2 hours
Secondary outcomes:
measure: Duration of period with deranged physiology, measured from moment of first occurrence until resolved or until arrival in hospital.
timeFrame: From pre-hospital ROSC to arrival at ED, approximately 1-2 hours
measure: Patient- and resuscitation factors related to deranged physiology and/or complications in the post arrest phase
timeFrame: From pre-hospital ROSC to arrival at ED, approximately 1-2 hours
measure: Opinion of EMS providers weather or not they felt they were able to provide optimal post arrest care
timeFrame: From pre-hospital ROSC to arrival at emergency department, approximately 1-2 hours
measure: Comparison of primary outcome of secondary outcomes between post ROSC patients attended by EMS only vs EMS and HEMS
timeFrame: From pre-hospital ROSC to arrival at emergency department, approximately 1-2 hours
measure: Frequency distribution of airway interventions (SGA or ETT) not performed (when deemed necessary)
timeFrame: From pre-hospital ROSC to arrival at emergency department, approximately 1-2 hours
measure: Frequency distribution of actively vomiting in absence of ETT after ROSC in prehospital setting
timeFrame: From pre-hospital ROSC to arrival at ED, approximately 1 to 2 hours
measure: Frequency distribution of the presence of hypoxia
timeFrame: From pre-hospital ROSC to arrival at ED, approximately 1 to 2 hours
measure: Frequency distribution of low cardiac output
timeFrame: From pre-hospital ROSC to ICU (or CCU) admission, up to about 1 hours
measure: Frequency distribution of hypoxic agitation upon arrival in ED or uncontrolled prehospital hypoxic agitation despite benzodiazepine administration or when benzodiazepines contraindicated)
timeFrame: From pre-hospital ROSC to arrival at ED, approximately 1-2 hours
measure: Frequency distribution of seizures during transport
timeFrame: From pre-hospital ROSC to arrival at ED, approximately 1-2 hours
measure: Frequency distribution of the presence of hyperthermia
timeFrame: From pre-hospital ROSC to arrival at ED, approximately 1-2 hours
Other outcomes:
Locations:
Study officials:
affiliation: University Medical Center Groningen
name: Ewoud ter Avest, dr
role: PRINCIPAL_INVESTIGATOR
References: