NCT04876664UnknownNot Applicable
Clinical Evaluation of Continuous Non-Invasive Blood Pressure Monitors With Adult Volunteers
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- GE Healthcare
- Enrollment
- 12
- Primary Endpoint
- Data collection of NIBP measurement
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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;
Outcomes
Primary Outcomes
Data collection of NIBP measurement
Time Frame: through study completion, average of one day
To collect data recorded by devices for cNIBP evaluation purposes.
Secondary Outcomes
- Collect number of adverse events (AEs), serious adverse events (SAEs), and device issues(through study completion, an average of one day)
Investigators
Similar Trials
Unknown
Not Applicable
Validation Study in Patients of a Non-invasive Blood Pressure Monitor for Perioperative UseIntraoperative HypotensionNCT03795831Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)100
Completed
Not Applicable
Clinical Validation of Continuous and Non-invasive Monitoring of Effective Pulmonary Volume.Critical IllnessNCT04045262Fernando Suarez Sipmann85
Completed
Not Applicable
Non-invasive Continuous Blood Pressure MonitoringBlood PressureNCT05224011PyrAmes Inc.8
Unknown
Not Applicable
Non-Invasive Blood Pressure Monitor Accuracy in Neonatal SubjectsNon-invasive Blood PressureNCT02642198Mortara Instrument25
Completed
Not Applicable
Validation of a Novel Non-invasive Continuous Blood Pressure Monitor in Children Ages 2- 17 Years-oldBlood PressureNCT04817137Boston Children's Hospital35