Validation Study of Non-Invasive Blood Pressure
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 22-009466
About this study
The purpose of this study is to compare measurements of blood pressure (BP) between the Philips non-invasive blood pressure (NIBP) system (including NIBP cuff and portable patient monitor) and invasive radial arterial line (A-line) in critical care patients.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patient admitted into the NICU, PICU, or ICU.
- Adult aged 18 years and older, or parent/legal guardian of minor, willing and able to understand and provide informed consent/assent in English language.
- Indication for NIBP cuff.
- Indication for radial arterial line.
- Meet the following stratification criteria across the study:
- Stratification:
- Subject Group 1:
- At least 3 patients shall be 2000 g in weight;
- At least 3 patients shall be ≥ 29 days and < 1 year of age;
- At least 3 patients shall be ≥ 1 year and < 3 years of age;
- The remaining patients may be from any of the above age or weight groups in order to complete the sample size;
- A patient can be in more than one category simultaneously.
- Subject Group 2 and 3:
- At least 30% male, 30% female;
- At least 1/8 of total adolescent/adult ≥ 5 years of age needs to be tested with each cuff size (4 cuff sizes total);
- at least 40 % of the subjects shall have a limb circumference that lies within the upper half of the specified range of use of the cuff; and
- at least 40 % shall have a limb circumference within the lower half of the specified range of use.
- Subject Group 3:
- At least 10% SBP ≤ 100mmHg;
- At least 10% SBP ≥ 160mmHg;
- At least 10% DBP ≤ 70mmHg;
- At least 10% DBP ≥ 85mmHg.
Exclusion Critieria:
- Inability to place the study device appropriately due to patient’s anatomy or condition.
- Known pregnancy or lactating women (self-report).
- Patients treated with an intra-aortic balloon pump.
- Aortic and mitral regurgitation (> 2nd degree).
- Measurements taken in the lateral position.
- Currently participating in another clinical trial with any product, treatment and/or medication that clinically interferes with the study endpoint(s).
- If valid SBP reference measurements for lateral difference is > 15 mmHg.
- If valid DBP reference measurements for lateral difference is > 10 mmHg.
- At the Principal Investigator’s discretion, subject does not qualify to participate in the study for any reasons that are not mentioned above.
Eligibility last updated 9/7/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available