NCT01324817

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

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, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

December 14, 2011

Status Verified

December 1, 2011

Enrollment Period

1.2 years

First QC Date

March 26, 2011

Last Update Submit

December 12, 2011

Conditions

Respiration

Keywords

Non-ContactRadarDopplerRespiratoryRespirationBreathingRateFrequencyRespiratory MechanicsRespiratory Rate MeasurementApneaSleep Apnea

Study Arms (1)

Hopitalized

Patients admitted to the hospital

Device: Kai Spot (v 2.1)Device: Kai Continuous (v 1.0)

Interventions

Kai Spot (v 2.1)DEVICE

The Kai Spot (v 2.1) provides a measurement of respiratory rate at a single point in time for neonates, pediatrics, and adults.

Also known as: Kai Spot
Hopitalized
Kai Continuous (v 1.0)DEVICE

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.

Also known as: Kai Continuous
Hopitalized

Eligibility Criteria

AgeUp to 2 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Neonates hospitalized at the Kapiolani Medical Center for Women and Children located in Honolulu, HI

You may qualify if:

  • \. Clinically stable

You may not qualify if:

  • \. Clinically unstable
  • Hypotensive requiring pressors
  • Intubated
  • \. Scheduled or planned (e.g., CT scan, central line placement) procedure during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

RECRUITING

MeSH Terms

Conditions

Respiratory AspirationApneaSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Venkataraman Balaraman, MD

    Kapiolani Medical Center For Women & Children

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Venkataraman Balaraman, MD

CONTACT

808-983-6718VBalaraman@kapiolani.org

Study Design

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

Study Record Dates

First Submitted

March 26, 2011

First Posted

March 29, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

December 14, 2011

Record last verified: 2011-12

Locations

US(1)