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

NCT04339257 | Unknown

• 1 other identifier: 201900756
• Study Type: observational
• Target: 175
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult (\>18 years) patients with ROSC after OHCA transported to University Hospital Groningen by the EMS services.

You may qualify if:

• Non-traumatic OHCA (as confirmed in notes of ambulance crew) with ROSC obtained before transport to hospital
• Age \> 18

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Post-Cardiac Arrest Syndrome

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Reperfusion Injury; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ewoud ter Avest, dr

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabian Lucassen, drs

CONTACT

0031-503614359; f.g.lucassen@umcg.nl

Ewoud ter Avest, dr

CONTACT

0031-503614359; e.ter.avest@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: April 9, 2020
• Study Start: May 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: November 1, 2021
• Last Updated: May 5, 2020

Record last verified: 2020-05