Substantial Equivalence Study for Kai Medical Non-Contact... | NCT01324817

Studies
Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitors for Use With Neonates

NCT01324817

Sponsor

Kai Medical, Inc.

Status

Unknown status

Last Update Posted

Dec 14, 2011Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Respiration

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Mar 2012Estimated

Completion Date

Mar 2012Estimated

First Submitted Date

Mar 26, 2011

First Submission Date that Met QC Criteria

Mar 28, 2011

First Posted Date

Mar 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2011

Last Update Posted Date

Dec 14, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The purpose of this study is to test two remote, Doppler radar-based sensors to measure and monitor respiratory rate. Specifically, in clinically stable neonatal patients the study aims to:

Obtain respiratory effort data of neonatal patients with remote Doppler radar systems modified from a system cleared by the FDA for adult use.
Determine if remote Doppler radar systems can accurately detect the respiratory rate of neonatal patients, compared with standard measurement systems.
Determine if unattended Doppler radar systems, operating for 4 hours, can accurately detect the respiratory rate of neonatal patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hopitalized		Patients admitted to the hospital	Device: Kai Spot (v 2.1) Device: Kai Continuous (v 1.0)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.	Hopitalized

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

2 Months

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Venkataraman Balaraman, MD	Contact	808-983-6718		VBalaraman@kapiolani.org

Overall Officials

Name	Affiliation	Role
Venkataraman Balaraman, MD	Kapiolani Medical Center For Women & Children	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kapiolani Medical Center for Women and Children	Recruiting	Honolulu	Hawaii	96826	United States

Condition Browse Module

MeSH Terms

ID	Term
D053120	Respiratory Aspiration
D001049	Apnea
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided