Ensayos clínicos

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.