Skip to main content
OpenTrials
Completed

NCT Number: NCT02942836

CareTaker Respiratory Rate Detection Study

The goal of the proposed study is to test the capability of the CareTaker monitor to extract the respiration signature from its acquired signal, and to determine a respiration rate of breaths/minute that meets or exceeds the performance levels of its predicate device.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiration Rate Detection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The goal of the proposed study is to test the capability of the CareTaker monitor to extract the respiration signature from its acquired signal, and to determine a respiration rate of breaths/minute that meets or exceeds the performance levels of its predicate device.

The detection approach of RSPR (respiratory rate) that the CareTaker technology takes is based on peak detection and pulse analysis of arterial pressure pulse signals, as well as spectral analysis of the raw CareTaker sensor signal.

The study was performed under the supervision of the Chesapeake IRB and involved 21 subjects >18 y who were monitored during spontaneous and metronome-paced breathing.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • > 18 years of age, who are able and willing to participate and have given verbal assent

Exclusion criteria

  • Unable to give written consent
  • <18 years of age
  • No or poor finger pulse, as determined through visual inspection for ischemic hands

Treatment and study plan

non-intrusive respiration monitor

Device

Equivalence of CareTaker's respiration rate detection capability to that of predicate device

Primary outcomes

  1. Respiration rate detection with accuracy of better than 3 breaths per minute

    Time frame: 15 minutes of matched respiration rates

    Comparison with performance of predicate device (accuracy within 3 breaths per minute).

Sponsors and collaborators

Lead sponsor

CareTaker Medical LLC

Industry

Registry information

Acronym: RSP

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 24, 2016
Registry last updated
Oct 24, 2016

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.