Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitors for Use With Neonates
NCT ID: NCT01324817
Last Updated: 2011-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2011-01-31
2012-03-31
Brief Summary
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Detailed Description
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1. Obtain respiratory effort data of neonatal patients with remote Doppler radar systems modified from a system cleared by the FDA for adult use.
2. Determine if remote Doppler radar systems can accurately detect the respiratory rate of neonatal patients, compared with standard measurement systems.
3. Determine if unattended Doppler radar systems, operating for 4 hours, can accurately detect the respiratory rate of neonatal patients.
Conditions
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Keywords
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Hopitalized
Patients admitted to the hospital
Kai Spot (v 2.1)
The Kai Spot (v 2.1) provides a measurement of respiratory rate at a single point in time for neonates, pediatrics, and adults.
Kai Continuous (v 1.0)
The Kai Continuous (v 1.0) provides a continuous monitor, measurement, and display of the respiratory rate, respiratory patterns, depth of breath, history/events and respiratory activity of a subject for neonates, pediatrics, and adults.
Interventions
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Kai Spot (v 2.1)
The Kai Spot (v 2.1) provides a measurement of respiratory rate at a single point in time for neonates, pediatrics, and adults.
Kai Continuous (v 1.0)
The Kai Continuous (v 1.0) provides a continuous monitor, measurement, and display of the respiratory rate, respiratory patterns, depth of breath, history/events and respiratory activity of a subject for neonates, pediatrics, and adults.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Hypotensive requiring pressors
* Intubated
2\. Scheduled or planned (e.g., CT scan, central line placement) procedure during the study period.
2 Months
ALL
Yes
Sponsors
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Kai Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Venkataraman Balaraman, MD
Role: PRINCIPAL_INVESTIGATOR
Kapiolani Medical Center For Women & Children
Locations
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Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Countries
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Central Contacts
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Facility Contacts
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Annette Amiotte, RN, BSN
Role: primary
Other Identifiers
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KAI-00006
Identifier Type: -
Identifier Source: org_study_id