Clinical trial NCT05022264: Remote Investigation and Assessment of Vital Signs
Official title: Remote Investigation and Assessment of Vital Signs
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Blood Pressure
Pulse Rate
Respiratory Rate
Oxygen Saturation
Body Temperature
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Göteborg University
First posted: 2021-08-26
Enrollment: 860
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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:

1. The patient is attending primary or secondary health care.
2. The subject has provided informed consent.
3. Age ≥18 years.
4. Fluent in Swedish, English, Somali or Arabic (we will translate the patient information and ensure an interpreter can be present for translating questions).
5. The patient is willing and able to give informed consent ".
6. The investigator determines that the new study device, and the reference methods, can be used as intended with adequate safety.
7. The delay in the management of each patient introduced by this study is approximately 15-20 minutes. Patients deemed being in such a severe medical condition that 15-20 minutes of delay is deemed detrimental will not be included.

WP3:

1. Patients attending primary health care.
2. The subject has provided informed consent.
3. Age ≥18 years.
4. Fluent in Swedish, English, Somali or Arabic (we will translate the patient information and ensure an interpreter can be present for translating questions).
5. The patient is willing and able to give informed consent .
6. The investigator determines that the new study device, and the reference methods, can be used as intended with adequate safety.
7. The delay in the management of each patient introduced by this study is approximately 15-20 minutes. Patients deemed being in such a severe medical condition that 15-20 minutes of delay is deemed detrimental will not be included.

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.

Primary outcomes:
measure: Agreement between conventional techniques and the new RIA-VS device
timeFrame: The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes
Secondary outcomes:
measure: Estimate test-retest reliability of the new RIA-VS device
timeFrame: The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes
measure: Evaluate the influence of different skin types on the validity of the new RIA-VS study device
timeFrame: The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes
Other outcomes:
Locations:
city: Ulricehamn
country: Sweden
facility: Hälsobrunnen Vårdcentral
Study officials:
affiliation: School of Public Health and Community Medicine, Gothengurg University, Sweden
name: Ronny Gunnarsson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: