Remote Investigation and Assessment of Vital Signs
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVastra Gotaland Region
About this trial
The vital signs (pulse, systolic and diastolic blood pressure, respiratory rate, oxygen saturation and body temperature) are critical in assessing the severity and prognosis of infections. 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). Accurately obtaining vital signs is also important when managing other categories of patients where it may be relevant to obtain some of the vital signs such as pulse and blood pressure.
This project aims to evaluate a new camera-based system for contactless measurement of vital signs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient is attending primary or secondary health care.
The subject has provided informed consent.
Age ≥18 years.
Fluent in Swedish, English, Somali or Arabic (we will translate the patient information and ensure an interpreter can be present for translating questions).
Disqualifiers
None
Trial population
Participants will be consecutive patients attending one of the clinics participating in the study. They will be asked for participation irrespective f reason for attending the clinic. Hence, this study does not focus on any specific medical condition. Participating clinics are one one hospital department for infectious diseases and four clinics for family medicine (general practice / primary health care centers)
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
RIA-VS
Diagnostic testMeasuring vital signs with a new contactless camera technique
Treatment groups
860 Participants
are divided into 1 treatment groupGroup A: Participants1 intervention
Trial outcomes
Primary outcomes
1
Agreement between conventional techniques and the new RIA-VS device
Estimate the agreement between vital signs estimated with the new RIA-VS study device and vital signs estimated using traditional techniques (the criterion validity). Vital signs in this context are heart rate (pulse), respiratory rate, oxygen saturation (SpO2), systolic as well as diastolic blood pressure, and body temperature. For each vital sign the following statistics will be calculated to answer the outcome measure: a) Validity of the new method: The gold standard will be the mean between the two reference methods. The first measurement of the new RIA-VS device will be the new method compared with the gold standard using a Bland-Altman plot. We will also produce simple scatter plots comparing the gold standard with the new RIA-VS device for illustration.
Time frame
The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutesSecondary outcomes
1
Estimate test-retest reliability of the new RIA-VS device
Estimate the new RIA-VS study device test-retest reliability and to compare this with the test-retest reliability of the reference method. Vital signs in this context are heart rate (pulse), respiratory rate, oxygen saturation (SpO2), systolic as well as diastolic blood pressure, and body temperature. For each vital sign the following statistics will be calculated to answer the outcome measure: 1. Test-retest reliability of the new RIA-VS method: The difference between the two tests will be plotted on the Y-axis and the mean value of the two estimates of the new RIA-VS device on the x-axis in a modified Bland-Altman plot. 2. Comparison of the random variability: The variance of the difference between the two measures using the reference method will be compared with the variance from the difference between the two RIA-VS estimates. This enables comparing the random variability of both the reference method as well as the new RIA-VS device.
Time frame
The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes2
Evaluate the influence of different skin types on the validity of the new RIA-VS study device
Investigate if different Fitzpatrick skin types influences the validity of the new RIA-VS study device. We will use the definition of skin types as described in: Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988;124(6):869-71). The statistics described in the primary outcome measure and the first secondary outcome measure (test-retest reliability) will be made separately for patients with Fitzpatrick skin color type 0-4 as well as type 5-6 to see if skin color influences readings with the new RIA-VS device.
Time frame
The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Vastra Gotaland Region
Lead sponsor
Göteborg University
Collaborator
Source ClinicalTrials.gov