StrokeParaNASPPNCT04137874
Paramedic - Norwegian Acute Stroke Prehospital Project
A study testing eSTROKE model in people with Stroke and Triage, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The main aim of the study is to show that patients with suspected acute stroke met by the emergency medical service and assessed using the eSTROKE model including prehospital NIHSS and a mobile application will identify a higher number of patients with stroke, than those who receive conventional prehospital care. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- eSTROKE model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 1 siteNorway
- Study dates
- 3 Jun 2019to Oct 2021
- Phase
- Interventional
- 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
Who may be able to join
- All patients with suspected acute stroke met by emergency medical services (ambulance and rapid response car)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostics and Triage of Acute Stroke by the National Institute of Stroke Scale (NIHSS) by Paramedics, the ParaNASPP (Paramedic - Norwegian Acute Stroke Prehospital Project) Study
The main aim of the study is to show that patients with suspected acute stroke met by the emergency medical service and assessed using the eSTROKE model including prehospital NIHSS and a mobile application will identify a higher number of patients with stroke, than those who receive conventional prehospital care.
Read the detailed description
Primary aims:
In patients with suspected stroke
- The proportion of patients hospitalized with a suspected acute stroke and discharged with a stroke diagnose is significantly increased using the ParaNASPP model compared with conventional prehospital care
- Time from onset to hospitalization is significantly reduced with the ParaNASPP model
- The ParaNASPP model identifies patients eligible for direct transportation for comprehensive stroke center
- Conditions
- Stroke, Triage, Paramedic, Mobile Application
- Being tested
- eSTROKE model, Control
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eSTROKE modelDiagnostic test
Also called ParaNASPP
The eSTROKE model includes an electronic learning module, a full day course with practical teaching of National Institute of Health Stroke Scale and a mobile application which will be used for communication with in-hospital stroke physician
ControlOther
Conventional prehospital care
| Study group | Role | What they receive |
|---|---|---|
| eSTROKE | Experimental | Not described Receives: Diagnostic Test: eSTROKE model |
| Control | Active comparator | Conventional prehospital care Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive predictive value (PPV) of the ParaNASPP model to identify patients suffering acute stroke.
Measured: On discharge from hospital - typically within 7 days.
Secondary outcomes (1)
Number of patients in hospitalized within the first 4 hours after symptom onset
Measured: first 4 hours On admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start3 Jun 2019
- Primary completion1 Jul 2021
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Oslo University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- ParaNASPP is a stepped wedge cluster randomized controlled intervention trial (SW-RCT).
- Masking
- None (open label)
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Air Ambulance Foundation
- Responsible party
- Principal investigator, Maren Ranhoff Hov, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137874
- Sponsor's protocol ID
- 2018/2310
- Acronym
- ParaNASPP
- Status last verified
- Sep 2021
- First submitted
- 11 Oct 2019
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fagerheim Bugge H, Guterud M, Larsen K, Toft M, Hov MR, Sandset EC. Presenting symptoms and diagnostic accuracy of prehospital stroke scales for patients with suspected mild minor stroke. Eur Stroke J. 2026 Jan 1;11(1):23969873251360592. doi: 10.1093/esj/23969873251360592.
PubMed 41614523Fagerheim Bugge H, Guterud M, Larsen K, Toft M, Hov MR, Sandset EC. Presenting symptoms and diagnostic accuracy of prehospital stroke scales for patients with suspected mild minor stroke. Eur Stroke J. 2025 Aug 11:23969873251360592. doi: 10.1177/23969873251360592. Online ahead of print.
PubMed 40785620Guterud M, Fagerheim Bugge H, Roislien J, Kramer-Johansen J, Toft M, Ihle-Hansen H, Bache KG, Larsen K, Braarud AC, Sandset EC, Ranhoff Hov M. Prehospital screening of acute stroke with the National Institutes of Health Stroke Scale (ParaNASPP): a stepped-wedge, cluster-randomised controlled trial. Lancet Neurol. 2023 Sep;22(9):800-811. doi: 10.1016/S1474-4422(23)00237-5.
PubMed 37596006Bugge HF, Guterud M, Bache KCG, Braarud AC, Eriksen E, Fremstad KO, Ihle-Hansen H, Ingebretsen SH, Kramer-Johansen J, Larsen K, Roislien J, Thorsen K, Toft M, Sandset EC, Hov MR. Paramedic Norwegian Acute Stroke Prehospital Project (ParaNASPP) study protocol: a stepped wedge randomised trial of stroke screening using the National Institutes of Health Stroke Scale in the ambulance. Trials. 2022 Feb 4;23(1):113. doi: 10.1186/s13063-022-06006-4.
PubMed 35120559
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostics and Triage of Acute Stroke by the National Institute of Stroke Scale (NIHSS) by Paramedics, the ParaNASPP (Paramedic - Norwegian Acute Stroke Prehospital Project) Study
- ClinicalTrials.gov ID
- NCT04137874
- Acronym / sponsor ID
- ParaNASPP / 2018/2310
- Conditions
- Stroke, Triage, Paramedic, Mobile Application
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Air Ambulance Foundation
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- Oct 2021 (estimated)
- First posted
- 24 Oct 2019 (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.
The main aim of the study is to show that patients with suspected acute stroke met by the emergency medical service and assessed using the eSTROKE model including prehospital NIHSS and a mobile application will identify a higher number of patients with stroke, than those who receive conventional prehospital care.
Detailed description
Primary aims:
In patients with suspected stroke
- The proportion of patients hospitalized with a suspected acute stroke and discharged with a stroke diagnose is significantly increased using the ParaNASPP model compared with conventional prehospital care
- Time from onset to hospitalization is significantly reduced with the ParaNASPP model
- The ParaNASPP model identifies patients eligible for direct transportation for comprehensive stroke center
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- ParaNASPP is a stepped wedge cluster randomized controlled intervention trial (SW-RCT).
| Arm | Type | Receives |
|---|---|---|
| eSTROKE | Experimental | Diagnostic Test: eSTROKE model |
| Control | Active comparator | Other: ControlConventional prehospital care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with suspected acute stroke met by emergency medical services (ambulance and rapid response car)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eSTROKE modelAlso: ParaNASPPThe eSTROKE model includes an electronic learning module, a full day course with practical teaching of National Institute of Health Stroke Scale and a mobile application which will be used for communication with in-hospital stroke physician | Diagnostic test | eSTROKE |
| ControlConventional prehospital care | Other | Control |
Primary outcome
Positive predictive value (PPV) of the ParaNASPP model to identify patients suffering acute stroke.
Time frame: On discharge from hospital - typically within 7 days.
1 secondary outcome
Number of patients in hospitalized within the first 4 hours after symptom onset
Time frame: first 4 hours On admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Derived from this study: PubMed 41614523Fagerheim Bugge H, Guterud M, Larsen K, Toft M, Hov MR, Sandset EC. Presenting symptoms and diagnostic accuracy of prehospital stroke scales for patients with suspected mild minor stroke. Eur Stroke J. 2026 Jan 1;11(1):23969873251360592. doi: 10.1093/esj/23969873251360592.
- Derived from this study: PubMed 40785620Fagerheim Bugge H, Guterud M, Larsen K, Toft M, Hov MR, Sandset EC. Presenting symptoms and diagnostic accuracy of prehospital stroke scales for patients with suspected mild minor stroke. Eur Stroke J. 2025 Aug 11:23969873251360592. doi: 10.1177/23969873251360592. Online ahead of print.
- Derived from this study: PubMed 37596006Guterud M, Fagerheim Bugge H, Roislien J, Kramer-Johansen J, Toft M, Ihle-Hansen H, Bache KG, Larsen K, Braarud AC, Sandset EC, Ranhoff Hov M. Prehospital screening of acute stroke with the National Institutes of Health Stroke Scale (ParaNASPP): a stepped-wedge, cluster-randomised controlled trial. Lancet Neurol. 2023 Sep;22(9):800-811. doi: 10.1016/S1474-4422(23)00237-5.
- Derived from this study: PubMed 35120559Bugge HF, Guterud M, Bache KCG, Braarud AC, Eriksen E, Fremstad KO, Ihle-Hansen H, Ingebretsen SH, Kramer-Johansen J, Larsen K, Roislien J, Thorsen K, Toft M, Sandset EC, Hov MR. Paramedic Norwegian Acute Stroke Prehospital Project (ParaNASPP) study protocol: a stepped wedge randomised trial of stroke screening using the National Institutes of Health Stroke Scale in the ambulance. Trials. 2022 Feb 4;23(1):113. doi: 10.1186/s13063-022-06006-4.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
Stroke
Recruiting
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eSTROKE model in people with Stroke and Triage, run by Oslo University Hospital at 1 site in Norway.
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 0 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 Sep 2021. 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 Norway. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive predictive value (PPV) of the ParaNASPP model to identify patients suffering acute stroke. (time frame: On discharge from hospital - typically within 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04137874, which also lists 4 linked publications.
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 Sep 2021.