NCT05025176

Brief Summary

To evaluate the clinical performance of the Hypotension Prediction Index obtained from the continuous, non-invasive Clear Sight monitor.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
4mo left

Started Aug 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Aug 2021Aug 2026

Study Start

First participant enrolled

August 20, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2026

Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

5 years

First QC Date

August 24, 2021

Last Update Submit

December 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • HPI

    Hypotension Prediction Index obtained from continuous, non-invasive ClearSight monitor will not differ significantly from the HPI concurrently obtained from the standard of care invasive radial arterial pressure monitor

    During surgical procedure

Study Arms (1)

Surgery requiring Invasive arterial pressure monitoring

Patients undergoing elective surgery that requires Invasive arterial pressure monitoring as standard of care.

Device: Non invasive arterial pressure monitoring

Interventions

Non invasive arterial pressure monitoring

Surgery requiring Invasive arterial pressure monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patents undergoing surgery with a planner arterial catheter placement

You may qualify if:

  • All Patients 18 years or older undergoing surgery with the use of general anesthesia and with planned arterial catheter placement and use of the HPI monitor.

You may not qualify if:

  • Adults unable to consent
  • Individuals who are not yet adults ( infants, children teenagers)
  • Pregnant Women
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Health System

Sacramento, California, 95817, United States

Location

Related Publications (1)

  • Sarhadi K, Hamman J, Avila J, Jian Z, Fleming NW. Hypotension prediction index: comparison between invasive and non-invasive pressure inputs. BMC Anesthesiol. 2025 Apr 29;25(1):221. doi: 10.1186/s12871-025-03086-y.

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2021

First Posted

August 27, 2021

Study Start

August 20, 2021

Primary Completion (Estimated)

August 20, 2026

Study Completion (Estimated)

August 20, 2026

Last Updated

December 5, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations