Use of a smartphone camera to assess pupil response to light in neurocritical care – comparison with pen torch
ISRCTN | ISRCTN53630869 |
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DOI | https://doi.org/10.1186/ISRCTN53630869 |
IRAS number | 324539 |
Secondary identifying numbers | IRAS 324539 |
- Submission date
- 23/02/2023
- Registration date
- 20/04/2023
- Last edited
- 20/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study is designed to compare the accuracy of measuring eye pupil size. It will compare the current standard of care, which is a pentorch and subjective assessment by a bedside nurse, to a new smartphone application using the camera and light of the phone to measure pupil size and responsiveness.
Who can participate?
Patients admitted to a specialist neurocritical care unit
What does the study involve?
Participants will have their pupils assessed by both methods hourly (which is standard) for a maximum of 10 days, during the day only. Not measuring at night provides respite for the patient (they will still have pentorch assessments) and reduces research staffing resources.
What are the possible benefits and risks of participating?
The interventions are non-invasive and as such there are no risks to participants. The proposed benefit is earlier identification of changes in pupil response, both in terms of improvement and deterioration.
Where is the study run from?
John Radcliffe Hospital (UK)
When is the study starting and how long is it expected to run for?
October 2022 to April 2023
Who is funding the study?
Solvemed Inc. (UK)
Who is the main contact?
Dr Simon Raby, simon.raby@ouh.nhs.uk
Contact information
Principal Investigator
Neurocritical Care
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
0000-0003-4886-9795 | |
Phone | +44 (0)1865741166 |
simon.raby@ouh.nhs.uk |
Study information
Study design | Single-centre non-randomized trial |
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Primary study design | Interventional |
Secondary study design | Non randomised study |
Study setting(s) | Hospital |
Study type | Diagnostic |
Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
Scientific title | Smartphone Pupillometry in Neurocritical Care - Comparison against PenTorch: the SPIN_CAT trial |
Study acronym | SPIN-CAT |
Study objectives | Smartphone pupillometry is more accurate than pentorch assessment of pupil responsiveness in neurocritical care patients. |
Ethics approval(s) | Approval pending, South Central - Oxford C REC |
Health condition(s) or problem(s) studied | Critically ill patients admitted to neurocritical care |
Intervention | Patients will have pupillary assessments made by pentorch and smartphone pupillometry. Pentorch is routine and the smartphone application is the additional intervention. Each intervention will be performed hourly during the day shift, for a maximum of 10 days per patient. Pupil traces will be processed by Solvemed to generate two indices per eye: baseline pupil diameter (millimetres), and pupil reactivity (binary – responsive or non-responsive). Measurement reliability for pentorch and Solvemed app (baseline diameter) will be computed independently, to give an r-squared statistic for each. The reliabilities will be compared using a Fisher-transformed Z-test. The validity of the app will be established by the correlation of the pentorch and app measures. The primary outcome is that the app offers improved reliability. To gauge efficiency, questionnaires to nursing staff will be analysed using qualitative nonparametric statistics. |
Intervention type | Device |
Pharmaceutical study type(s) | |
Phase | Phase III |
Drug / device / biological / vaccine name(s) | Solvemed Neurapeek |
Primary outcome measure | Pupil diameter (millimetres) and pupil reactivity (binary – responsive or non-responsive) measured using the two modalities (pentorch and Solvemed smartphone application), performed hourly during the day shift, for a maximum of 10 days per patient |
Secondary outcome measures | There are no secondary outcome measures |
Overall study start date | 01/10/2022 |
Completion date | 01/04/2023 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 20 |
Key inclusion criteria | Any patient admitted to neurocritical care |
Key exclusion criteria | Pupillary assessment not possible due to ocular pathology |
Date of first enrolment | 01/04/2023 |
Date of final enrolment | 01/04/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Sponsor information
Industry
82-88 Hills Rd
Cambridge
CB2 1LQ
England
United Kingdom
Phone | +44 (0)7966663309 |
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michal.wlodarski@solvemed.ai |
Funders
Funder type
Industry
No information available
Results and Publications
Intention to publish date | 01/06/2023 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Stored in non-publicly available repository |
Publication and dissemination plan | The study will be published in a high-impact peer-reviewed journal. |
IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository: Following video capture, the video is uploaded onto the company-owned Amazon S3 server storage space (the cloud storage), where the captured videos and any associated data are stored in Amazon SQL databases. To ensure the stored data is secure, company applies an industry-standard Hypertext Transfer Protocol Secure (HTTPS) encryption protocol for all traffic between its smartphones and AWS servers. In addition, company applies suitable company-level policies regarding the access levels and procedures regarding every Amazon AWS component, using appropriate Amazon roles and Amazon policies. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Protocol file | version 1.0 | 03/08/2022 | 07/03/2023 | No | No |
Additional files
Editorial Notes
20/04/2023: Trial's existence confirmed by Solvemed Inc.