Substantial Equivalence Study for Kai Sensors RSpot Non-Contact Respiratory Rate Spot Check
Completed
Conditions studied: Respiration
In brief
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.
Key facts
- Study ID
- NCT00827905
- Run by
- Kai Medical, Inc.
- People needed
- 20
- Starts
- 2009-01-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2010-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- The Queen's Medical Center — Honolulu, Hawaii, United States
- The Queen's Medical Center — Honolulu, Hawaii, United States
Full record on ClinicalTrials.gov
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