NIBP Validation Study

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Philips Clinical & Medical Affairs Global
Study ID
NCT05673408
Status
Recruiting
Apply to this trial

Conditions

  • Critical Illness

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Philips IntelliVue X3 Patient Monitor — DEVICE
    All subjects enrolled in this study will receive one Philips non-invasive blood pressure cuff. This cuff will be connected via compatible hose to the Philips IntelliVue X3 monitor hosting the released or investigational NIBP algorithm. The invasive blood pressure from the radial arterial line will also be connected to the Philips IntelliVue X3 monitor. The Philips IntelliVue X3 monitor will in turn be connected to a laptop for data collection.

Study Details

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.

Key Dates

Start date
Jun 23, 2023
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
189 participants (estimated)

Arms

  • Arm: Subject Group 1
    Neonates, Infant, Children \<3 years of age
  • Arm: Subject Group 2
    Children 3-12 years of age
  • Arm: Subject Group 3
    Adolescent/Adult \>12 years of age

Primary Outcome Measure

Philips NIBP System Equivalence to Radial Arterial Line [ Time Frame: Through study completion, approximately 1 year ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Lynnette Harris, BSN,RN,CCRC
Ashish Khanna, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239
Sarah Feller
Ross Martini, MD (PRINCIPAL_INVESTIGATOR)
University Health Women's and Children's HospitalSan AntonioTexas78229
Diana G Anzueto
[email protected]
2105675254
Amy Quinn, MD (PRINCIPAL_INVESTIGATOR)
Megan Foster, MD (SUB_INVESTIGATOR)
University of UtahSalt Lake CityUtah84112-

Find similar trials in Jacksonville, FL

By research site
Mayo Clinic Jacksonville· Jacksonville, FLWake Forest University Health Sciences· Winston-Salem, NCOregon Health & Science University· Portland, ORUniversity Health Women's and Children's Hospital· San Antonio, TXUniversity of Utah· Salt Lake City, UT

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