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| Name | Class |
|---|---|
| Göteborg University | OTHER |
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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.
STUDY DESIGN:
A method comparison design with three work packages (WP):
WP1: Focus on estimating validity and reliability of the new study device to measure body temperature.
WP2: Focus on estimating validity and reliability of the new study device to measure all vital signs except body temperature (pulse, systolic and diastolic blood pressure, respiratory rate and oxygen saturation).
WP3: Focus on estimating if there is any difference in the validity and reliability of the new study device to measure all vital signs (except body temperature) in subjects with Fitzpatrick skin type 5-6 as compared with those of skin type 1-4.
STUDY POPULATION:
WP1: Patients aged ≥18 years admitted to or attending a hospital clinic. WP2: Patients aged ≥18 year attending primary health care or patients being admitted to a hospital clinic.
WP3: Individuals aged ≥18 years attending primary health care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants | All participants will have their vital signs measured with conventional techniques as well as with the new experimental medical device (labelled RIA-VS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RIA-VS | Diagnostic Test | Measuring vital signs with a new contactless camera technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
The same subject can't be enrolled more than once with the exception that subjects in WP1 may also be recruited to WP2.
WP1+WP2:
WP3:
Exclusion Criteria:
Subjects are free to withdraw from the study at any point. Subjects will also be withdrawn from the study in case of unexpected depressed level of consciousness from inclusion up until all investigations are completed (during approximately 15-20 minutes). Any reduction in consciousness will incur that the subject is withdrawn.
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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)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ronny Gunnarsson, MD PhD | Contact | +46 31 786 6835 | ronny.gunnarsson@gu.se | |
| Carl Wikberg, PhD | Contact | +46 703821660 | carl.wikberg@allmed.gu.se |
| Name | Affiliation | Role |
|---|---|---|
| Ronny Gunnarsson, MD PhD | School of Public Health and Community Medicine, Gothengurg University, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hälsobrunnen Vårdcentral | Recruiting | Ulricehamn | 52337 | Sweden |
A deidentified raw data file will be publicly available.
Raw data will be made available upon acceptance of final manuscript for publication
Publicly available to anyone
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| The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes |
| 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. | The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes |