Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05022264
Other study ID # U1111-1261-8273
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source Vastra Gotaland Region
Contact Ronny Gunnarsson, MD PhD
Phone +46 31 786 6835
Email ronny.gunnarsson@gu.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 860
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Diagnostic Test:
RIA-VS
Measuring vital signs with a new contactless camera technique

Locations

Country Name City State
Sweden Hälsobrunnen Vårdcentral Ulricehamn

Sponsors (2)

Lead Sponsor Collaborator
Vastra Gotaland Region Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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:
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.
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.
The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Completed NCT05997303 - Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT03918486 - Caretaker vs. Routine Blood Pressure Sphygmomanometer
Completed NCT03410342 - The Effects of Types of Fruits and Vegetables on Vascular Function N/A
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT04087070 - Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia
Completed NCT03294928 - Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers N/A
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03997461 - Comparison of Arterial Tonometry Sensor With Standard Oscillometric Blood Pressure Monitoring Device N/A
Completed NCT03290716 - Diet, ExerCIse and carDiovascular hEalth (DECIDE) - Salt Reduction Strategies for the Elderly in Nursing Homes in China N/A
Recruiting NCT06460233 - Blood Pressure Changes After Bariatric Surgery
Recruiting NCT05196048 - Blood Pressure Sensor of Watch-type Device With ECG Technology
Terminated NCT03325933 - Resistance Training and Cardiometabolic Health N/A
Not yet recruiting NCT06405880 - Pharmacist Case Finding and Intervention for Vascular Prevention Trial N/A
Completed NCT02924454 - Effects of Lipid Emulsion on the Pharmacokinetic and Pharmacodynamic Properties of Metoprolol. Phase 4
Completed NCT02451059 - Reducing Socioeconomic Disparities in Health at Pediatric Visits N/A
Active, not recruiting NCT02670967 - Effects of Soluble Fiber on Blood Pressure: A Meta-analysis of Randomly-controlled Trials N/A
Completed NCT02239744 - Intervention Study on the Health Impact of Air Filters in Chinese Adults N/A
Completed NCT02271633 - Nitrate Supplementation; Source Phase 4