NCT00827905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
Last Updated

August 6, 2010

Status Verified

August 1, 2010

Enrollment Period

Same day

First QC Date

January 21, 2009

Last Update Submit

August 4, 2010

Conditions

Respiration

Keywords

Non-ContactRadarRespiratoryRespirationBreathingRateFrequencyRespiratory MechanicsRespiratory Rate Measurement

Study Arms (1)

Hospitalized

Patients admitted to the hospital

Device: RSpot Non-Contact Respiratory Rate Spot Check

Interventions

RSpot Non-Contact Respiratory Rate Spot CheckDEVICE

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.

Also known as: KaiSpot, RSpot 100, RSpot, Non-Contact Respiratory Rate Spot Check
Hospitalized

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients Hospitalized at the Queen's Medical Center in Honolulu, HI

You may qualify if:

  • Adult \>18 years old
  • Hospitalized on Tower 6 or Pauahi 6 or Pauahi 4
  • Clinically stable
  • Able to provide informed consent

You may not qualify if:

  • Clinically unstable
  • Hypotensive requiring pressors or intra-aortic balloon pump
  • Intubated
  • Dyspnea or chest pain at rest
  • Resting tachycardia (heart rate \>100 bpm)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Todd Seto, MD

    The Queen's Medical Center

    PRINCIPAL INVESTIGATOR

  • Olga Boric-Lubecke, PhD

    University of Hawaii

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 21, 2009

First Posted

January 23, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

August 6, 2010

Record last verified: 2010-08

Locations

US(1)