Recruiting

Observational Study

Sponsor:

Kai Medical, Inc.

Code:

NCT01324817

Conditions

Respiration

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Kai Spot (v 2.1)

Kai Continuous (v 1.0)

Study Details

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.

Conditions

Respiration

Study ID

NCT01324817

Start date

Jan, 2011

Status verified date

Dec, 2011

Completion date

Mar, 2012

Anticipated

Primary completion date

Mar, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

  • 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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Hopitalized

Patients admitted to the hospital

Interventions

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.

Central Contacts and Locations

Central contacts

Venkataraman Balaraman, MD

808-983-6718VBalaraman@kapiolani.org

Locations

Kapiolani Medical Center for Women and Children

Recruiting

Honolulu, Hawaii, United States, 96826

Contacts

Annette Amiotte, RN, BSN

808-983-6386aamiotte@kapiolani.org

Principal Investigator:

Venkataraman Balaraman, MD

More Information

Sponsor

Kai Medical, Inc.

Last update posted

Dec 14, 2011

Last verified

Dec, 2011

Keywords

  • Non-Contact
  • Radar
  • Doppler
  • Respiratory
  • Respiration
  • Breathing
  • Rate
  • Frequency
  • Respiratory Mechanics
  • Respiratory Rate Measurement
  • Apnea
  • Sleep Apnea

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kai Medical, Inc. on 2011-12-14.