Clinical trial NCT00827905: Substantial Equivalence Study for Kai Sensors RSpot Non-Contact Respiratory Rate Spot Check
Official title: Remote Doppler System to Measure Heart Rate and Breathing Pattern
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiration
Keywords: Non-Contact
Radar
Respiratory
Respiration
Breathing
Rate
Frequency
Respiratory Mechanics
Respiratory Rate Measurement
Lead sponsor: Kai Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients Hospitalized at the Queen's Medical Center in Honolulu, HI

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
Study officials:
affiliation: The Queen's Medical Center
name: Todd Seto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Hawaii
name: Olga Boric-Lubecke, PhD
role: STUDY_DIRECTOR
References: