NCT03710473

Brief Summary

The aim of the present study is to evaluate the accuracy of measuring beat-by-beat diastolic blood pressure from a non-invasive, cuffless and non-obtrusive watch-like optical device worn at the wrist.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 11, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

1.8 years

First QC Date

October 11, 2018

Last Update Submit

November 7, 2024

Conditions

Systemic Hypertension

Keywords

HypertensionNon-invasive blood pressure MonitoringPhotoplethysmography

Outcome Measures

Primary Outcomes (1)

  • Comparison of diastolic blood pressures (in mmHg) assessed via non-invasive vs. invasive blood pressure (arterial line) measurement

    Statistical comparison of both measures of diastolic blood pressure

    24 hours

Secondary Outcomes (2)

  • Descriptive assessment: time until normalization of measurement after re-calibration of diastolic blood pressure measurement using the non-invasive approach

    24 hours

  • Descriptive analysis of comparison to measurements at the fingertip (non-invasive vs. fingertip diastolic blood pressure assessment)

    24 hours

Interventions

Optical sensor, Pulse watchDIAGNOSTIC_TEST

Continuous blood pressure monitoring obtained by a Pulse watch

Eligibility Criteria

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

Consecutive patients scheduled for cardiac or vascular surgery at the Department of Cardiovascular Surgery of Inselspital, Bern.

You may qualify if:

  • Scheduled for cardiac or vascular surgery, with presence of a radial arterial line for perioperative management;
  • Willing and able to provide Informed Consent.

You may not qualify if:

  • Known severe aortic stenosis (mean gradient \> 40 mmHg, valve area \< 1 cm2);
  • Emergency patient (i.e. unscheduled OR).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inselspital, Dept of Intensive Care Medicine

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • David Reineke, MD

    Dept of Cardiovascular Surgery

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 11, 2018

First Posted

October 18, 2018

Study Start

April 1, 2019

Primary Completion

December 30, 2020

Study Completion

January 15, 2021

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)