Covid-19 Triage Using Camera-based AI

NCT04383457 | Completed

• 1 other identifier: U1111-1251-4114
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

The vital signs are critical in assessing the severity and prognosis of infections, such as Covid-19. The devices used today for measuring the vital signs have to be in physical contact with the patients. There is an apparent risk of transferring infections from one patient to the next (or to healthcare professionals). This project aims to evaluate a new camera-based system for contactless measurement of vital signs as well as an artificial intelligence (AI) predicting hospitalization or death within 30 days. This particular study will evaluate the new system's ability without interfering with standard care of the patient.

Conditions

Coronavirus Infections

Keywords

Vital signs; Pulse; Blood pressure; Respiratory rate; Oxygen saturation; Temperature

Outcome Measures

Primary Outcomes (6)

• Agreement between the new camera based method and reference standard to estimate body temperature

  Body temperature will be measured with the new camera based method as well as with a conventional ear thermometer. Both measurements will estimate the body temperature in degrees Celsius. The agreement between body temperature estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.

  Two minutes between measurements

• Agreement between the new camera based method and reference standard to estimate heart rate

  Heart rate will be measured with the new camera based method as well as with a conventional apparatus for measuring pulse rate. Both measurements will estimate the heart rate in beats per minute. The agreement between body temperature estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.

  Two minutes between measurements

• Agreement between the new camera based method and reference standard to estimate blood oxygen saturation

  Blood oxygen saturation will be measured with the new camera based method as well as with a conventional apparatus for measuring blood oxygen saturation. Both measurements will estimate the blood oxygen saturation in percent (ranging from 0-100%). The agreement between blood oxygen saturation estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.

  Two minutes between measurements

• Agreement between the new camera based method and reference standard to estimate systolic blood pressure

  Systolic blood pressure will be measured with the new camera based method as well as with a conventional apparatus for measuring systolic blood pressure. Both measurements will estimate the systolic blood pressure in mm Hg. The agreement between systolic blood pressure estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.

  Two minutes between measurements

• Agreement between the new camera based method and reference standard to estimate diastolic blood pressure

  Diastolic blood pressure will be measured with the new camera based method as well as with a conventional apparatus for measuring diastolic blood pressure. Both measurements will estimate the diastolic blood pressure in mm Hg. The agreement between diastolic blood pressure estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.

  Two minutes between measurements

• Agreement between the new camera based method and reference standard to estimate respiratory rate

  Respiratory rate will be measured with the new camera based method as well as manually using a stethoscope. Both measurements will estimate the respiratory rate in breath per minute. The agreement between respiratory rate estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.

  Two minutes between measurements

Secondary Outcomes (6)

• Prediction of hospital admission using vital signs estimated using reference standard methods

  Hospital admission for any cause up until 30 days after inclusion

• Prediction of death using vital signs estimated using reference standard methods

  Death for any cause up until 30 days after inclusion

• Prediction of hospital admission using vital signs estimated using the new camera based method

  Hospital admission for any cause up until 30 days after inclusion

• Prediction of death using vital signs estimated using the new camera based method

  Death for any cause up until 30 days after inclusion

• Prediction of hospital admission using raw camera data

  Hospital admission for any cause up until 30 days after inclusion

Interventions

RIA-device (Remote Investigation and Assessment) DEVICE

The investigated new system consists of a high-speed digital video camera, a digital radiometric infrared camera, LED lights and a computer for data recording. This system faces the subject at a distance of approximately one meter, capturing a 30 second recording of the subject's face.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients attending the emergency department at Östra sjukhuset Gothenburg for a suspected infection.

You may qualify if:

• The patient is attending for triage presenting with symptoms of an infection.
• Subject has provided informed consent
• Age ≥18 years
• Fluent in Swedish (reading, writing, conversational)
• Mental state is such that he or she is able to understand and give informed consent to participation in the study by signing the Information and Consent Form
• The investigator determines that the new method, and the reference methods, can be used as intended with adequate reliability and safety
• The time for investigations in this study is estimated to approximately 15-20 minutes. Vital signs will be handed over to the care provider responsible for the further management of the patient saving approximately 5-10 minutes of their time. Hence, the delay in the management of each patient introduced by this study is approximately 10 minutes. Patients deemed being in such a severe medical condition on arrival, that 10 minutes of delay is deemed detrimental will not be included.

You may not qualify if:

• Patient request to be withdrawn from the study.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Detectivio AB: collaborator

Study Sites (1)

Östra Sjukhuset

Gothenburg, Sweden

Location

Related Publications (1)

• Malmberg S, Khan T, Gunnarsson R, Jacobsson G, Sundvall PD. Remote investigation and assessment of vital signs (RIA-VS)-proof of concept for contactless estimation of blood pressure, pulse, respiratory rate, and oxygen saturation in patients with suspicion of COVID-19. Infect Dis (Lond). 2022 Sep;54(9):677-686. doi: 10.1080/23744235.2022.2080249. Epub 2022 Jun 1.

  PMID: 35651319 RESULT

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ronny K Gunnarsson, MD PhD

  Primary Health care, Regionhalsan, Region Vastra Gotaland, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 12, 2020
• Study Start: June 15, 2020
• Primary Completion: October 8, 2020
• Study Completion: October 8, 2020
• Last Updated: June 22, 2023

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: It will be made available upon final publication
• Access Criteria: A complete de-identified data set will be made made publicly available in a data repository. The exact data-repository is not yet decided.

Locations

SE (1)