NCT05022264 Remote Investigation and Assessment of Vital Signs
| NCT ID | NCT05022264 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vastra Gotaland Region |
| Condition | Blood Pressure |
| Study Type | OBSERVATIONAL |
| Enrollment | 860 participants |
| Start Date | 2022-03-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 860 participants in total. It began in 2022-03-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Ronny Gunnarsson, MD PhD
PRINCIPAL INVESTIGATOR
School of Public Health and Community Medicine, Gothengurg University, Sweden
Frequently Asked Questions
Who can join the NCT05022264 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Blood Pressure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05022264 currently recruiting?
Yes, NCT05022264 is actively recruiting participants. Contact the research team at ronny.gunnarsson@gu.se for enrollment information.
Where is the NCT05022264 trial being conducted?
This trial is being conducted at Ulricehamn, Sweden.
Who is sponsoring the NCT05022264 clinical trial?
NCT05022264 is sponsored by Vastra Gotaland Region. The principal investigator is Ronny Gunnarsson, MD PhD at School of Public Health and Community Medicine, Gothengurg University, Sweden. The trial plans to enroll 860 participants.