Performance Evaluation of the ViTrack Continuous Non-invasive Blood Pressure Measurement Device

NCT ID: NCT06719518

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-15

Study Completion Date

2025-12-15

Brief Summary

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The purpose of this study is to calibrate the ViTrack™ arterial pressure waveform against intra-arterial pressure (IAP) in dynamic clinical settings and to assess the optimized ViTrack™ design to measure and continuously track blood pressure over a wide, clinically-relevant pressure range.

Detailed Description

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Conditions

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Blood Pressure

Keywords

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ViTrack blood pressure monitoring

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ViTrack device

ViTrack device

Intervention Type DEVICE

In the operating room the ViTrack™ device will be applied the wrist. Monitoring will start in the operating room and will continue throughout the surgery. The device can be worn on either wrist. It will be connected to a power unit that will capture blood pressure data and stream the data to a secure laptop

Interventions

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ViTrack device

In the operating room the ViTrack™ device will be applied the wrist. Monitoring will start in the operating room and will continue throughout the surgery. The device can be worn on either wrist. It will be connected to a power unit that will capture blood pressure data and stream the data to a secure laptop

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* scheduled to undergo noncardiac surgery with general or spinal anesthesia
* clinical indication for invasive intra-arterial pressure monitoring
* palpable pulse

Exclusion Criteria

* difference of greater than 10 mmHg in the left versus right arm oscillometric systolic blood pressure
* Upper extremity arteriovenous hemodialysis shunt
* Upper extremity amputation
* Planned surgical position/draping that precludes access to the wrist
* Wrist distortion or pain from arthritis
* Prior trauma or surgery at the radial artery monitoring site
* Unable to provide informed consent
* Clinical contraindication as determined by the clinical team or study investigators
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Turan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehmet Turan, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Mehmet Turan, MD

Role: CONTACT

Phone: (713) 500-6251

Email: [email protected]

Mohammad Khudirat

Role: CONTACT

Phone: (713) 500-5558

Email: [email protected]

Facility Contacts

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Mehmet Turan, MD

Role: primary

Mohammad Khudirat

Role: backup

Other Identifiers

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HSC-MS-24-0970

Identifier Type: -

Identifier Source: org_study_id