Evaluation of Continuous Non Invasive Blood Pressure With Adult Volunteers
Not Applicable
- Conditions
- Blood Pressure
- Interventions
- Device: measuring blood pressure with noninvasive blood pressure device
- Registration Number
- NCT04876664
- Lead Sponsor
- GE Healthcare
- Brief Summary
A study to collect data recorded by devices for cNIBP evaluation purposes.
- Detailed Description
The study is going to be conducted to collect data from the devices used in the study for future AMS engineering purposes as deemed appropriate by the Sponsor.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- Healthy male or female, aged 18 years or older (≥18 years);
- Willing and able to give informed consent for participation in the study;
- Able and willing to comply with all the study requirements.
Exclusion Criteria
- Who is pregnant or lactating;
- Who is a smoker;
- Who has consumed alcohol in the last 24 hours;
- Who has been previously diagnosed with Ataxia or balance disorder;
- Who has been previously diagnosed with Raynaud's disease/ syndrome/ phenomenon;
- Who has been previously a diagnosed cardiovascular condition requiring medication or has an internal pacemaker;
- Who has an injury, deformity, A-V fistula, or other characteristic limiting the placing of cuffs on arms/fingers;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ambulatory monitoring solution measuring blood pressure with noninvasive blood pressure device this study has only one arm
- Primary Outcome Measures
Name Time Method Data collection of NIBP measurement through study completion, average of one day To collect data recorded by devices for cNIBP evaluation purposes.
- Secondary Outcome Measures
Name Time Method Collect number of adverse events (AEs), serious adverse events (SAEs), and device issues through study completion, an average of one day The safety objective is to collect safety information, including type and number of adverse events (AE), serious adverse events (SAE), and device issues.