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

NCT ID: NCT00827905

Last Updated: 2010-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-01-31

Brief 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.

Detailed 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.

Conditions

Respiration

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Hospitalized

Patients admitted to the hospital

RSpot Non-Contact Respiratory Rate Spot Check

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

KaiSpot; RSpot 100; RSpot; Non-Contact Respiratory Rate Spot Check

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kai Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Kai Medical, Inc.

Principal Investigators

Todd Seto, MD

Role: PRINCIPAL_INVESTIGATOR

The Queen's Medical Center

Olga Boric-Lubecke, PhD

Role: STUDY_DIRECTOR

University of Hawaii

Locations

The Queen's Medical Center

Honolulu, Hawaii, United States

Countries

United States

Other Identifiers

RA-2008-061

Identifier Type: -

Identifier Source: secondary_id

KAI-00003

Identifier Type: -

Identifier Source: org_study_id