Remote Investigation and Assessment of Vital Signs

Launched by VASTRA GOTALAND REGION · Aug 19, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new camera-based system that can measure important vital signs—like blood pressure, pulse rate, respiratory rate, oxygen levels, and body temperature—without having to touch the patient. This is important because traditional methods can pose a risk of spreading infections between patients or to healthcare workers. By using a contactless approach, the goal is to make it safer and easier to monitor patients, especially those with infections or other health concerns.

To participate in the study, individuals must be at least 18 years old, fluent in Swedish, English, Somali, or Arabic, and able to give informed consent. Participants should be seeking care at a health facility and must be stable enough so that a short delay in their treatment (about 15-20 minutes) won’t harm them. Participants can expect to have their vital signs measured using this new system and will have the option to withdraw from the study at any time if they feel uncomfortable. The research team will ensure that all information is clearly communicated and will provide support if needed.

Gender

ALL

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.