RECRUITING

NIBP Validation Study

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Conditions

Critical IllnessNIBP ValidationNon-Invasive Blood Pressure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 for Subject Group 2 and 3, and radial or umbilical arterial line for neonates (A-line) in critical care patients.

Official Title

Non-Invasive Blood Pressure Validation Study

Quick Facts

Study Start:2023-06-23
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05673408

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient admitted into the NICU, PICU, ICU, or OR (operating room)
  2. * Adult aged 18 years and older, or parent/legal guardian of minor, willing and able to understand and provide informed consent/assent
  3. * Indication for NIBP cuff
  4. * Indication for radial arterial line for Subject Group 2 and Subject Group 3, and radial or umbilical arterial line for Subject Group 1
  5. * Meet the following stratification criteria across the study:
  6. * Subject Group 1:
  7. * At least 3 patients shall be \<1000 g in weight
  8. * At least 3 patients shall be 1000 to 2000 g in weight
  9. * At least 3 patients shall be \> 2000 g in weight
  10. * At least 3 patients shall be ≥ 29 days and \< 1 year of age
  11. * At least 3 patients shall be ≥ 1 year and \< 3 years of age
  12. * The remaining patients may be from any of the above age or weight groups in order to complete the sample size
  13. * A patient can be in more than one category simultaneously
  14. * Subject Group 2:
  15. * At least 30% male, 30% female
  16. * Limb circumference distributed as specified in ISO81060-2:2018/Amd2:2024.
  17. * Subject Group 3:
  18. * At least 30% male, 30% female
  19. * Limb circumference distributed as specified in ISO81060- 2:2018/Amd-2:2024.
  20. * At least 10% SBP ≤ 100mmHg
  21. * At least 10% SBP ≥ 160mmHg
  22. * At least 10% DBP ≤ 70mmHg
  23. * At least 10% DBP ≥ 85mmHg
  1. * Inability to place the study device appropriately due to patient's anatomy or condition
  2. * Known pregnancy or lactating women (self-report)
  3. * Patients treated with an intra-aortic balloon pump
  4. * Aortic and mitral regurgitation (\> 2 nd degree)
  5. * Measurements taken in the lateral position
  6. * Currently participating in another clinical trial with any product, treatment and/or medication that clinically interferes with the study endpoint(s)
  7. * If valid SBP reference measurements for lateral difference is \> 15 mmHg (except for neonates with umbilical A-line)
  8. * If valid DBP reference measurements for lateral difference is \> 10 mmHg (except for neonates with umbilical A-line)
  9. * At the Principal Investigator's discretion, subject does not qualify to participate in the study for any reasons that are not mentioned above

Contacts and Locations

Study Contact

Natalie Hernandez, MBA
CONTACT
210-517-4405
natalie.hernandez@philips.com
Shakun Karki
CONTACT
shakun.karki@philips.com

Study Locations (Sites)

Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
University Health Women's and Children's Hospital
San Antonio, Texas, 78229
United States
University of Utah
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Philips Clinical & Medical Affairs Global

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-23
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-06-23
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • NIBP Validation
  • Non-Invasive Blood Pressure

Additional Relevant MeSH Terms

  • Critical Illness