Out-Of-Hospital Cardiac ArrestPOP-ROCNCT04339257
Pre-hospital Post ROSC Care: Are we Achieving Our Targets?
An observational study of Out-Of-Hospital Cardiac Arrest and Post Cardiac Arrest Syndrome, run by University Medical Center Groningen.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest, Post Cardiac Arrest Syndrome, Emergency Medical Services
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- May 2020to Nov 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult (>18 years) patients with ROSC after OHCA transported to University Hospital Groningen by the EMS services.
Who may be able to join
- Non-traumatic OHCA (as confirmed in notes of ambulance crew) with ROSC obtained before transport to hospital
- Age > 18
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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.
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From pre-hospital ROSC to arrival at ED, approximately 1-2 hours
Secondary outcomes (11)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From pre-hospital ROSC to arrival at ED, approximately 1-2 hours
Frequency distribution of seizures during transport
Measured: 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
Measured: From pre-hospital ROSC to arrival at ED, approximately 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study startMay 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabian Lucassen, University Medical Center Groningen
- Investigators
- Ewoud ter Avest, dr, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339257
- Sponsor's protocol ID
- 201900756
- Acronym
- POP-ROC
- Status last verified
- May 2020
- First submitted
- 16 Mar 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Patients With a ROSC After OHCA Would Potentially Benefit From Physician Driven Post Cardiac Arrest Care?
- ClinicalTrials.gov ID
- NCT04339257
- Acronym / sponsor ID
- POP-ROC / 201900756
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (>18 years) patients with ROSC after OHCA transported to University Hospital Groningen by the EMS services.
Key inclusion criteria (2 listed)
- Non-traumatic OHCA (as confirmed in notes of ambulance crew) with ROSC obtained before transport to hospital
- Age > 18
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
11 secondary outcomes
Duration of period with deranged physiology, measured from moment of first occurrence until resolved or until arrival in hospital.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: From pre-hospital ROSC to arrival at ED, approximately 1 to 2 hours
Frequency distribution of the presence of hypoxia
Time frame: From pre-hospital ROSC to arrival at ED, approximately 1 to 2 hours
Frequency distribution of low cardiac output
Time frame: 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)
Time frame: From pre-hospital ROSC to arrival at ED, approximately 1-2 hours
Frequency distribution of seizures during transport
Time frame: From pre-hospital ROSC to arrival at ED, approximately 1-2 hours
Frequency distribution of the presence of hyperthermia
Time frame: From pre-hospital ROSC to arrival at ED, approximately 1-2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ewoud ter Avest, dr principal investigator
University Medical Center Groningen
Questions about this trial
What is this clinical trial studying?
An observational study of Out-Of-Hospital Cardiac Arrest and Post Cardiac Arrest Syndrome, run by University Medical Center Groningen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabian Lucassen, drs (0031-503614359, f.g.lucassen@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: From pre-hospital ROSC to arrival at ED, approximately 1-2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.