Out-Of-Hospital Cardiac ArrestNCT04670354
Differential Diagnosis and Cause-specific Treatment During OHCA
An observational study of Out-Of-Hospital Cardiac Arrest, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Differential diagnosis: ultrasound, blood gas analyse combined with examination of the patient and environment is used during Out Of Hospital Cardiac Arrest (OHCA) to screen possible underlying cause of cardiac arrest. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 5 Jan 2021to Dec 2022
- How long will I take part?
- 30 Days
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Non-traumatic out-of-hospital cardiac arrest patients encountered by the helicopter emergency medical services.
Who may be able to join
- non-traumatic out-of-hospital cardiac arrest encountered by the helicopter emergency medical services team
Who cannot join
- return of spontaneous circulation before HEMS crew arrival
- termination of resuscitation attempt before HEMS crew arrival
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
FinnHEMS 10
Vantaa, 01530
Jouni Nurmi, MD, PhD, +358505951576, jouni.nurmi@hus.fi
Milla Jousi, MD, PhD, milla.jousi@hus.fi
About this study
Official title: Differential Diagnosis and Cause-specific Treatment During OHCA - a Prospective Feasibility Study
Differential diagnosis: ultrasound, blood gas analyse combined with examination of the patient and environment is used during Out Of Hospital Cardiac Arrest (OHCA) to screen possible underlying cause of cardiac arrest. Helicopter Emergency Medical Service (HEMS) in Helsinki has unraveled a protocol for performing differential diagnosis during OHCA. Our study aim is to test the feasibility of this protocol. Our study is a prospective medical record based study. The anesthesiologist operating in the HEMS unit fills a form after encounter of OHCA. Questioners focus on how long did execution of the protocol take, and the cause if the protocol was not completed.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- out of hospital cardiac arrest, differential diagnosis, prospective, ultrasound, blood gas analyse
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful execution of differential diagnosis protocol
Successful and all-inclusive execution of the following items during cardiopulmonary resuscitation: ultrasound examination, arterial blood gas analyze, clinical examination, obtaining structured history from next of kin and searching of the environment.
Measured: 60 minutes
Secondary outcomes (2)
Rate of cause-specific treatment during resuscitation
Any therapy given as a treatment of presumed reversible cause of a cardiac arrest (excluding chest-compressions, ventilation, airway management, oxygen, epinephrine, amiodarone and defibrillation)
Measured: 60 minutes
Time needed to complete the differential diagnostics protocol
Delay from patient encountered by the prehospital critical care physician to the all diagnostics performed (during cardiopulmonary resuscitation)
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start5 Jan 2021
- Primary completion5 Jun 2022 (estimated)
- Study completionDec 2022 (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 Helsinki University Central HospitalThe 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
- 100 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jouni Nurmi, MD, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670354
- Sponsor's protocol ID
- HUS-247-2020-9
- Status last verified
- May 2022
- First submitted
- 16 Nov 2020
- Last updated
- 24 May 2022
- 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 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Diagnosis and Cause-specific Treatment During OHCA - a Prospective Feasibility Study
- ClinicalTrials.gov ID
- NCT04670354
- Acronym / sponsor ID
- HUS-247-2020-9
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- out of hospital cardiac arrest, differential diagnosis, prospective, ultrasound, blood gas analyse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 5 Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 17 Dec 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.
Differential diagnosis: ultrasound, blood gas analyse combined with examination of the patient and environment is used during Out Of Hospital Cardiac Arrest (OHCA) to screen possible underlying cause of cardiac arrest. Helicopter Emergency Medical Service (HEMS) in Helsinki has unraveled a protocol for performing differential diagnosis during OHCA. Our study aim is to test the feasibility of this protocol. Our study is a prospective medical record based study. The anesthesiologist operating in the HEMS unit fills a form after encounter of OHCA. Questioners focus on how long did execution of the protocol take, and the cause if the protocol was not completed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Non-traumatic out-of-hospital cardiac arrest patients encountered by the helicopter emergency medical services.
Key inclusion criteria (1 listed)
- non-traumatic out-of-hospital cardiac arrest encountered by the helicopter emergency medical services team
Key exclusion criteria (2 listed)
- return of spontaneous circulation before HEMS crew arrival
- termination of resuscitation attempt before HEMS crew arrival
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
Successful execution of differential diagnosis protocol
Time frame: 60 minutes
Successful and all-inclusive execution of the following items during cardiopulmonary resuscitation: ultrasound examination, arterial blood gas analyze, clinical examination, obtaining structured history from next of kin and searching of the environment.
2 secondary outcomes
Rate of cause-specific treatment during resuscitation
Time frame: 60 minutes
Time needed to complete the differential diagnostics protocol
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Out-Of-Hospital Cardiac Arrest
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
Not yet recruiting
The OXY-VENT Study
Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Out-Of-Hospital Cardiac Arrest, run by Helsinki University Central Hospital at 1 site in Finland.
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 1 inclusion and 2 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 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jouni Nurmi, MD, PhD (+358505951576, jouni.nurmi@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful execution of differential diagnosis protocol (time frame: 60 minutes). 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 24 May 2022.