Stroke, AcuteTelestroke 2NCT04578002
Telestroke 2: Prehospital Triage of Patients With Suspected Stroke Using Onsite Mobile Telemedicine
An observational study of Stroke, Acute, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study is to investigate clinical efficacy of the pre-hospital triage of patients with suspected acute stroke by using advanced telecommunication tools with digital audio and video real-time streaming. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- prehospital telemedical triage
- How many people
- 94 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Nov 2022to Aug 2024
- 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: Any patient aged ≥ 18 years with suspected acute stroke as per the first judgement of the paramedics on-site at the University hospital of Basel.
Who may be able to join
- suspected acute stroke as per the first judgement of the paramedics on-site
Who cannot join
- Patients with a known history of epilepsia or non-epileptic seizures
- Patients after/while displaying an epileptic seizure
- Recent head trauma
- Patient with a reduced Glasgow Coma Scale or other condition not allowing Rapid Arterial oCclusion Evaluation (RACE) examination
Trial locations and contacts
1 site in 1 country.
Sebastian Thilemann, Dr. med. contact
Switzerland1 site, 1 recruiting
- Recruiting
Stroke Center, Neurology, University Hospital Basel
Basel, 4031
Philippe Lyrer, Prof. Dr. med., +41 (0) 61 265 4435, philippe.lyrer@usb.ch
Sebastian Thilemann, Dr. med., +41 61 32 85307, sebastian.thilemann@usb.ch
About this study
Official title: Telestroke 2: Prehospital Triage of Patients With Suspected Stroke Using Onsite Mobile Telemedicine- Efficacy Study
This study is to investigate clinical efficacy of the pre-hospital triage of patients with suspected acute stroke by using advanced telecommunication tools with digital audio and video real-time streaming.
Read the detailed description
One of today's main challenges in stroke medicine is to further decrease event-to-treatment-time. On-site, pre-hospital, clinical assessment of patients with suspected acute stroke can optimize further diagnostic and treatment pathways after patient arrival at the dedicated stroke center. A telemedical approach (interactive video and audio streaming) allows time efficient pre-hospital triage, via patient evaluation by simple, pre-defined assessment measures and a standardized questionnaire. This study is to investigate clinical efficacy of the pre-hospital triage of patients with suspected acute stroke by using advanced telecommunication tools with digital audio and video real-time streaming.
- Conditions
- Stroke, Acute
- Being tested
- prehospital telemedical triage
- Keywords
- pre-hospital triage, Stroke, suspected, Telemedicine, telemedical triage, Door-to-treatment-time
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prehospital telemedical triageOther
Prehospital Triage of Patients with Suspected Stroke Using Onsite Mobile Telemedicine approach (interactive video and audio streaming). In patients with suspected stroke, a prehospital patient evaluation by end-to-end encrypted real-time audio- and video streaming from the pre-hospital setting to an in-hospital stroke physician, located at the University hospital of Basel, is requested and initiated (telestroke-path). The process is supervised and evaluated by an in-hospital stroke physician in real-time. Patients considered having an acute stroke will be directly transferred to cerebral imaging via CT. All other patients will follow conventional stroke path.
What is being measured
The primary outcome is the main question the study is designed to answer.
Door-to-treatment-time (minutes)
Door-to-treatment-time (minutes), assessed as door-to-needle-time and door-to-groin-puncture-time.
Measured: one point assessment at baseline
Secondary outcomes (3)
National Institutes of Health Stroke Scale (NIHSS) at 24hours
Score to quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Measured: one point assessment at 24hours after hospital admission
National Institutes of Health Stroke Scale (NIHSS) at 90 days
Score to quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Measured: one point assessment at 90 days after hospital admission
modified Rankin Scale (mRS) at 90 days
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6).
Measured: one point assessment at 90 days after hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start14 Nov 2022
- Primary completionJul 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- propatient Forschungsstiftung
- Responsible party
- Sponsor
- Investigators
- Philippe Lyrer, Prof. Dr. med., Principal investigator, Stroke Center, Neurology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578002
- Sponsor's protocol ID
- 2022-0126; me20Lyrer
- Acronym
- Telestroke 2
- Status last verified
- Mar 2024
- First submitted
- 30 Sep 2020
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telestroke 2: Prehospital Triage of Patients With Suspected Stroke Using Onsite Mobile Telemedicine- Efficacy Study
- ClinicalTrials.gov ID
- NCT04578002
- Acronym / sponsor ID
- Telestroke 2 / 2022-0126; me20Lyrer
- Conditions
- Stroke, Acute
- Keywords
- pre-hospital triage, Stroke, suspected, Telemedicine, telemedical triage, Door-to-treatment-time
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- propatient Forschungsstiftung
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 8 Oct 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.
This study is to investigate clinical efficacy of the pre-hospital triage of patients with suspected acute stroke by using advanced telecommunication tools with digital audio and video real-time streaming.
Detailed description
One of today's main challenges in stroke medicine is to further decrease event-to-treatment-time. On-site, pre-hospital, clinical assessment of patients with suspected acute stroke can optimize further diagnostic and treatment pathways after patient arrival at the dedicated stroke center. A telemedical approach (interactive video and audio streaming) allows time efficient pre-hospital triage, via patient evaluation by simple, pre-defined assessment measures and a standardized questionnaire. This study is to investigate clinical efficacy of the pre-hospital triage of patients with suspected acute stroke by using advanced telecommunication tools with digital audio and video real-time streaming.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient aged ≥ 18 years with suspected acute stroke as per the first judgement of the paramedics on-site at the University hospital of Basel.
Key inclusion criteria (1 listed)
- suspected acute stroke as per the first judgement of the paramedics on-site
Key exclusion criteria (4 listed)
- Patients with a known history of epilepsia or non-epileptic seizures
- Patients after/while displaying an epileptic seizure
- Recent head trauma
- Patient with a reduced Glasgow Coma Scale or other condition not allowing Rapid Arterial oCclusion Evaluation (RACE) examination
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 |
|---|---|---|
| prehospital telemedical triagePrehospital Triage of Patients with Suspected Stroke Using Onsite Mobile Telemedicine approach (interactive video and audio streaming). In patients with suspected stroke, a prehospital patient evaluation by end-to-end encrypted real-time audio- and video streaming from the pre-hospital setting to an in-hospital stroke physician, located at the University hospital of Basel, is requested and initiated (telestroke-path). The process is supervised and evaluated by an in-hospital stroke physician in real-time. Patients considered having an acute stroke will be directly transferred to cerebral imaging via CT. All other patients will follow conventional stroke path. | Other | – |
Primary outcome
Door-to-treatment-time (minutes)
Time frame: one point assessment at baseline
Door-to-treatment-time (minutes), assessed as door-to-needle-time and door-to-groin-puncture-time.
3 secondary outcomes
National Institutes of Health Stroke Scale (NIHSS) at 24hours
Time frame: one point assessment at 24hours after hospital admission
National Institutes of Health Stroke Scale (NIHSS) at 90 days
Time frame: one point assessment at 90 days after hospital admission
modified Rankin Scale (mRS) at 90 days
Time frame: one point assessment at 90 days after hospital admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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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.
Sebastian Thilemann, Dr. med. contact
Philippe Lyrer, Prof. Dr. med. principal investigator
Stroke Center, Neurology, University Hospital Basel
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 Stroke, Acute, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 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 Mar 2024. 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 Switzerland. 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 Philippe Lyrer, Prof. Dr. med. (+41 61 265 4435, philippe.lyrer@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Door-to-treatment-time (minutes) (time frame: one point assessment at baseline). 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 Mar 2024.