Substantial Equivalence Study for Kai Sensors RSpot Non-Contact Respiratory Rate Spot Check

Respiration Clinical Trial

Official title:

Remote Doppler System to Measure Heart Rate and Breathing Pattern

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827905
• Other study ID #: KAI-00003
• Secondary ID: RA-2008-061
• Status: Completed
• Phase: N/A
• First received: January 21, 2009
• Last updated: August 4, 2010
• Start date: January 2009
• Est. completion date: January 2009

Study information

• Verified date: August 2010
• Source: Kai Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether the respiratory rate provided by the Kai Sensors RSpot 100 Non-Contact Respiratory Rate Spot Check is as accurate as that provided by the Welch Allyn Propaq Encore model 242 and the Embla Embletta system with Universal XactTrace respiratory effort sensor and Somnologica for Embletta software.

Description:

Currently, medical professionals obtain respiratory rate for vital signs assessments either by counting the number of breaths during a 15, 30, or 60 second interval and multiplying to obtain breaths per minute, or by reading the respiratory rate off of a multiparameter vital signs monitor (such as a Welch Allyn Propaq Monitor), that provides respiratory effort information based on the change of AC impedance through ECG leads. The Respiration channel (RESP) of the Welch Allyn Propaq is intended to detect the rate or absence of respiratory effort, deriving the signal by measuring the AC impedance between the selected terminals of the ECG electrodes. The RSpot 100 Non-Contact Respiratory Rate Spot Check provides an alternative to the medical professional counting respiratory rate or reading the rate from a vital signs monitor designed for continuous respiratory rate monitoring. The Kai Sensors RSpot 100 Non-Contact Respiratory Rate Spot Check is used for a one-time measurement of respiratory rate as part of a vital signs assessment in the hospital or other clinical settings.

In this study, the RSpot is operated simultaneously with two other systems that provide a respiratory rate: Welch Allyn Propaq Encore model 242 and Embletta system with Universal XactTrace and Somnologica software. A respiratory rate is also obtained by counting respiratory excursions for the same duration as the RSpot measurement interval, 15, 30, or 60 seconds. The rates obtained from each of the four measurement methods are then compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult >18 years old

• Hospitalized on Tower 6 or Pauahi 6 or Pauahi 4

• Clinically stable

• Able to provide informed consent

Exclusion Criteria:

• Clinically unstable

1. Hypotensive requiring pressors or intra-aortic balloon pump

2. Intubated

3. Dyspnea or chest pain at rest

4. Resting tachycardia (heart rate >100 bpm)

5. Requires supplemental (e.g., nasal canula or face mask) oxygen

• Scheduled or planned (e.g., CT scan, central line placement) procedure during the 30 minute study period

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Respiration

Intervention

Device:
• RSpot Non-Contact Respiratory Rate Spot Check
The Kai Sensors RSpot 100 provides a measurement of respiratory rate at a single point in time. It uses a low-power radar to detect respiratory effort, and analyzes the respiratory effort signal to provide a respiratory rate.

Locations

Country	Name	City	State
United States	The Queen's Medical Center	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Kai Medical, Inc.

Country where clinical trial is conducted

United States,