CClinicalTrials.gg
Status unknownNCT03009656HOGANUpdated Jul 8, 2019

Assessing Accuracy of Clinical Diagnosis and Lesion Location in Acute Neurological Deficits - How Good Are Neurologists?

An observational study in Stroke Syndrome, Stroke Hemorrhagic and Stroke, Acute, sponsored by Insel Gruppe AG, University Hospital Bern. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-08.

Sponsored by Insel Gruppe AG, University Hospital Bern · Observational

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
800
Ages
18 Years and older
Sex
All
01

Study summary

The emergency setting for acute neurological conditions, such as stroke, is peculiar due to time pressure and limited resources for further diagnostics. Clinical skills are essential for swift and accurate bedside diagnosis and thus are the basis for early and correct treatment. This is especially evident in the context of computed tomography being the standard neuroimaging method world-wide with its limitations for detecting smaller infarcts, strokes in the posterior fossa and reduced sensitivity for stroke mimics, such as epileptic seizures or migraine aura. To date, the accuracy of clinical bedside diagnosis of stroke by neurologists verified by magnetic resonance imaging (MRI) in the emergency setting has not been studied in detail. In order to improve clinical diagnosing and future treatment it is essential to quantify the accuracy of clinical diagnosis of stroke in the emergency setting ("how good are neurologists?") and to assesses whether there are any differences between experienced staff neurologists and junior physicians.

Read the detailed description

Background:

The emergency setting for acute neurological conditions, such as stroke, is peculiar due to time pressure and limited resources for further diagnostics. Clinical skills are essential for swift and accurate bedside diagnosis and thus are the basis for early and correct treatment. This is especially evident in the context of computed tomography being the standard neuroimaging method world-wide with its limitations for detecting smaller infarcts, strokes in the posterior fossa and reduced sensitivity for stroke mimics, such as epileptic seizures or migraine aura. To date, the accuracy of clinical bedside diagnosis of stroke by neurologists verified by magnetic resonance imaging (MRI) in the emergency setting has not been studied in detail. Management of acute stroke patients is a main interest of the neurovascular research group at Inselspital Bern. For example, the investigators analysed the prediction of large vessel occlusion in acute stroke patients by clinical examination and found a significant association of stroke severity measured with the NIHSS score and location of vessel occlusion. Analysis of outcome in stroke patients with mild and rapidly improving symptoms demonstrated that three of four of these patients had a favourable outcome, but those with a central vessel occlusion were likely to deteriorate with poor outcome. These studies showed that there is a correlation of clinical symptoms with the mechanism of stroke, which is important for the outcome after treatment. Importantly, however, the quality of clinical assessment itself is likely highly variable, for example depending on the experience of the treating physician. Factors influencing this clinical assessment, which needs to be done under high temporal and emotional pressure in the emergency setting have not been investigated so far but might be crucial for rapid and successful treatment ("time is brain").In order to improve clinical diagnosing and future treatment it is essential to quantify the accuracy of clinical diagnosis of stroke in the emergency setting ("how good are neurologists?") and to assesses whether there are any differences between experienced staff neurologists and junior physicians.

Rationale:

By assessing whether prediction of aetiology of acute neurological deficits is experience-based the investigators aim to understand what symptoms/signs impede the in-experienced from swiftly making the correct diagnosis in the emergency setting. This should help to improve resident training and with this treatment of patients with acute neurological deficits.

02

Conditions studied

  • Stroke Syndrome
  • Stroke Hemorrhagic
  • Stroke, Acute
  • Strokes Thrombotic
  • Emergencies
  • Diagnostic Self Evaluation

Keywords

  • Stroke
  • Emergency
  • Focal Neurological Deficits
  • Diagnostic
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with focal neurological deficits in the Emergency Room of Inselspital Bern.

Inclusion criteria

  • Age ≥ 18 years.
  • Non-refusal of "general consent"
  • Patients with focal clinical neurological deficits with symptom onset of \< 6 hours or wake-up strokes.

Exclusion criteria

Exclusion Criteria:

  • Interval from symptom onset to clinical examination of > 6 hours.
  • Patients who do not have focal clinical neurological deficit at examination will not be included in the study.
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No

Interventions

  • OtherNo study specific interventions
05

What researchers measure

Primary outcomes

  1. Proportion of correct initial diagnoses by emergency physicians in patients with focal clinical neurological deficits

    Primary endpoint is the proportion of correct initial diagnoses by emergency physicians in patients with focal clinical neurological deficits, calculated by comparing the initial assessment with the final diagnosis at discharge. If the initial assessment was correct, the diagnosis of the emergency physician will be rated as correct (correct answer = Ac), if it was incorrect, it will be rated as incorrect (incorrect answer = Ai). The proportion of accurate initial diagnoses will be calculated as: Ac / (Ac + Ai)

    Time frame: 7 days +/- 7 days

06

Study locations

1 of 1 sites recruiting
  • Bern University Hospital - Inselspital
    Bern, BE 3010, Switzerland
    • Christoph Schankin, PD Dr. med. · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03009656
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Responsible party
Sponsor
First posted
Jan 4, 2017
Start date
Jan 10, 2017
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Jul 8, 2019

Study contacts

Christoph Schankin, PD Dr. med.
Contact
christoph.schankin@insel.ch
Christoph Schankin, PD Dr. med.
principal investigator · Insel Gruppe AG, University Hospital Bern

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion