Respiration Clinical Trial
Official title:
Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitors for Use With Neonates
The purpose of this study is to test the accuracy of two devices (the Kai Spot (v 2.1) and the Kai Continuous (v 1.0) that can measure breathing patters (how fast you breath) without wires and without touching the body.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 2 Months |
Eligibility |
- Inclusion Criteria: 1. Clinically stable - Exclusion Criteria: 1. Clinically unstable - Hypotensive requiring pressors - Intubated 2. Scheduled or planned (e.g., CT scan, central line placement) procedure during the study period. |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
Lead Sponsor | Collaborator |
---|---|
Kai Medical, Inc. |
United States,
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