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

Out-Of-Hospital Cardiac Arrest Clinical Trial

— POP-ROC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04339257
• Other study ID #: 201900756
• Status: Not yet recruiting
• Start date: May 2020
• Est. completion date: November 2021

Study information

• Verified date: May 2020
• Source: University Medical Center Groningen
• Contact: Fabian Lucassen, drs
• Phone: 0031-503614359
• Email: f.g.lucassen[@]umcg.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 175
• Est. completion date: November 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Emergency Medical Services
• Heart Arrest
• Out-of-Hospital Cardiac Arrest
• Post Cardiac Arrest Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Frequency distribution of seizures during transport		From pre-hospital ROSC to arrival at ED, approximately 1-2 hours
Secondary	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