Photo-Plethysmographic Camera to Monitor Heart Rate, Resp... | NCT00989859

Studies
Photo-Plethysmographic Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants

NCT00989859

Sponsor

University of California, Irvine

Status

Completed

Last Update Posted

Nov 1, 2022Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Child Development

Interventions

Plethysmographic monitoring

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

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Oct 2, 2009

First Submission Date that Met QC Criteria

Oct 5, 2009

First Posted Date

Oct 6, 2009Estimated

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

Oct 28, 2022

Last Update Posted Date

Nov 1, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Beckman Laser Institute and Medical Center, Willem Verkruysse, Ph.D., Associate Specialist, University of California, IrvinePrincipal Investigator

Lead Sponsor

University of California, IrvineOTHER

Collaborators

Name	Class
Beckman Laser Institute University of California Irvine	OTHER

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 researchers want to determine if ambient light, plethysmographic , can monitor reliably heart rate, respiration rate and oxygen saturation in infant patients in a hospital setting.

Detailed Description

The plethysmographic signal is typically strong on children. This provides a reliable heart rate monitor. However, to measure oxygen saturation, a quantitative value of the strength at two wavelength regions (green and red) is required. It is also not known if the normal ambient light is spectrally appropriate to analyze the video signals for oxygenation. With the current prototype of our system, we can monitor heart rate reliably and estimate oxygen saturation in adults, using normal artificial light or daylight, entering through a window. Heart rate and oxygen saturation will be extracted from the plethysmographic signal off the cheek, forehead or hand while the respiration rate may be retrieved from the plethysmographic signal off the chest area.

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Plethysmographic monitoring		Plethysmographic monitoring	Device: Plethysmographic monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plethysmographic monitoring	Device	Plethysmographic monitoring	Plethysmographic monitoring

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ambient light, PPG can monitor reliably heart rate, respiration rate and oxygen saturation (SpO2)		24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

infant in NICU at CHOC hospital

Exclusion Criteria:

non-infant

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

1 Week

Standard Ages

Child

Study Population

infant

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stuart Nelson, MD	Beckman Laser Institute University of California Irvine	Study Director
William Verkruysse, PhD	Beckman Laser Institute University of California Irvine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHOC		Orange	California	92868	United States