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Pre-hospital Post ROSC Care: Are we Achieving Our Targets?

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04339257
Acronym
POP-ROC
Enrollment
175
Registered
2020-04-09
Start date
2020-05-31
Completion date
2021-11-30
Last updated
2020-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergency Medical Services, Out-Of-Hospital Cardiac Arrest, Post Cardiac Arrest Syndrome

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.

Interventions

None listed

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 withFrom pre-hospital ROSC to arrival at ED, approximately 1-2 hoursAny 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

MeasureTime frameDescription
Patient- and resuscitation factors related to deranged physiology and/or complications in the post arrest phaseFrom 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 careFrom pre-hospital ROSC to arrival at emergency department, approximately 1-2 hoursMeasured by a survey, filled out by EMS crew at arrival at ED
Comparison of primary outcome of secondary outcomes between post ROSC patients attended by EMS only vs EMS and HEMSFrom 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-Airway intervention (SGA or ETT) not performed (when deemed necessary) in ED. NB NOT change of SGA for ETT when SGA is functioning well
Frequency distribution of actively vomiting in absence of ETT after ROSC in prehospital settingFrom pre-hospital ROSC to arrival at ED, approximately 1 to 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 hoursAny 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
Frequency distribution of low cardiac outputFrom pre-hospital ROSC to ICU (or CCU) admission, up to about 1 hoursPresence 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
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 hoursAssessed by physician who enrolls patient
Frequency distribution of seizures during transportFrom pre-hospital ROSC to arrival at ED, approximately 1-2 hours
Frequency distribution of the presence of hyperthermiaFrom pre-hospital ROSC to arrival at ED, approximately 1-2 hoursDefined as a temperature \>37.5 celsius
Frequency distribution of the presence of hypoxiaFrom pre-hospital ROSC to arrival at ED, approximately 1 to 2 hoursSaO2 \<94% on at least two consecutive readings

Contacts

Primary ContactFabian Lucassen, drs
f.g.lucassen@umcg.nl0031-503614359
Backup ContactEwoud ter Avest, dr
e.ter.avest@umcg.nl0031-503614359

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026