Child DevelopmentNCT00989859
Photo-Plethysmographic Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants
An observational study of Child Development, run by University of California, Irvine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 1 weekHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Plethysmographic monitoring
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 1 week
- All sexes
- Healthy volunteers accepted
- Child
Study population: infant
Who may be able to join
- infant in NICU at CHOC hospital
Who cannot join
- non-infant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Using Photo-plethysmographic (PPG) Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants.
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.
Read the 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.
- Conditions
- Child Development
- Being tested
- Plethysmographic monitoring
- Keywords
- monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plethysmographic monitoringDevice
Plethysmographic monitoring
| Study group | Role | What they receive |
|---|---|---|
| Plethysmographic monitoring | Plethysmographic monitoring Receives: Device: Plethysmographic monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
ambient light, PPG can monitor reliably heart rate, respiration rate and oxygen saturation (SpO2)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Stuart Nelson, MD, Study director, Beckman Laser Institute University of California IrvineWilliam Verkruysse, PhD, Principal investigator, Beckman Laser Institute University of California Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989859
- Sponsor's protocol ID
- 20097046.
- Status last verified
- Oct 2022
- First submitted
- 2 Oct 2009
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Using Photo-plethysmographic (PPG) Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants.
- ClinicalTrials.gov ID
- NCT00989859
- Acronym / sponsor ID
- 20097046.
- Conditions
- Child Development
- Keywords
- monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 6 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plethysmographic monitoring | – | Device: Plethysmographic monitoringPlethysmographic monitoring |
Who may qualify
- Ages
- 1 minute to 1 week
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- infant
Key inclusion criteria (1 listed)
- infant in NICU at CHOC hospital
Key exclusion criteria (1 listed)
- non-infant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plethysmographic monitoringPlethysmographic monitoring | Device | Plethysmographic monitoring |
Primary outcome
ambient light, PPG can monitor reliably heart rate, respiration rate and oxygen saturation (SpO2)
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuart Nelson, MD study director
Beckman Laser Institute University of California Irvine
William Verkruysse, PhD principal investigator
Beckman Laser Institute University of California Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ambient light, PPG can monitor reliably heart rate, respiration rate and oxygen saturation (SpO2) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.