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Clinical Trials/NCT04339257
NCT04339257
Unknown
Not Applicable

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

University Medical Center Groningen0 sites175 target enrollmentMay 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Out-Of-Hospital Cardiac Arrest
Sponsor
University Medical Center Groningen
Enrollment
175
Primary Endpoint
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
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2020
End Date
November 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fabian Lucassen

Principal Investigator

University Medical Center Groningen

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: From pre-hospital ROSC to arrival at ED, approximately 1-2 hours

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

Secondary Outcomes

  • 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)
  • Frequency distribution of hypoxic agitation upon arrival in ED or uncontrolled prehospital hypoxic agitation despite benzodiazepine administration or when benzodiazepines contraindicated)(From pre-hospital ROSC to arrival at ED, approximately 1-2 hours)
  • Frequency distribution of the presence of hyperthermia(From pre-hospital ROSC to arrival at ED, approximately 1-2 hours)
  • Frequency distribution of the presence of hypoxia(From pre-hospital ROSC to arrival at ED, approximately 1 to 2 hours)
  • Frequency distribution of low cardiac output(From pre-hospital ROSC to ICU (or CCU) admission, up to about 1 hours)
  • Opinion of EMS providers weather or not they felt they were able to provide optimal post arrest care(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)(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 seizures during transport(From pre-hospital ROSC to arrival at ED, approximately 1-2 hours)
  • Duration of period with deranged physiology, measured from moment of first occurrence until resolved or until arrival in hospital.(From pre-hospital ROSC to arrival at ED, approximately 1-2 hours)

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