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Completed

NCT Number: NCT03710473

Non-Invasive Blood Pressure Measurement in Critically Ill PAtients Post Cardiosurgical Therapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inselspital, Dept of Intensive Care Medicine

Bern, 3010, Switzerland

About this study

Given the prevalence of hypertension in society and the current limitations associated with oscillometric cuffs, the need for a continuous cuffless alternative for blood pressure home monitoring at a global scale is paramount. Such a device would not only improve the global control of blood pressure, but more generally, it could have a larger social impact by improving the comfort and reducing the stress for the clinical management of hypertensive patients.

In the present study the investigators seek to investigate, as a primary purpose, to evaluate the accuracy of non-invasive blood pressure measurements via a watch-like optical sensor and compare these to standard monitoring (arterial line).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • (Chronic) pace-maker/ defibrillator in situ at study inclusion;
  • Known severe aortic stenosis (mean gradient > 40 mmHg, valve area < 1 cm2);
  • Rhythmogenic heart disease (resting heart rate > 120/min) at time of study inclusion;
  • Emergency patient (i.e. unscheduled OR).

Treatment and study plan

Optical sensor, Pulse watch

Diagnostic Test

Continuous blood pressure monitoring obtained by a Pulse watch

Primary outcomes

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

    Time frame: 24 hours

    Statistical comparison of both measures of diastolic blood pressure

Secondary outcomes

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

    Time frame: 24 hours

    To evaluate the influence of the re-calibration time interval (amount of time in-between two consecutive calibrations of the optical devices) on the accuracy of diastolic blood pressure assessment.

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

    Time frame: 24 hours

    To compare the accuracy when applied to photoplethysmographic signals measured at the wrist versus signals measured at the fingertip.

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Ava AG
  • CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

Registry information

Official study title

Non-invasive and Continuous Monitoring of Diastolic Blood Pressure: a Prospective Observational Study - IMPACT

Acronym: IMPACT

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Oct 18, 2018
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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