Cardiac SurgeryNCT03870373
Performance of Pulse Oximeter Sensors in Neonates
An observational study of Cardiac Surgery, run by Taiwan Aulisa Medical Devices Technologies, Inc. at 1 site in United States.
Trial summary
Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples during cardiac surgery. Read more about this study
- Who is it for?
- Ages 0 days to 1 year
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Pulse Oximeter
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 10 May 2019
- 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 0 days to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Neonatal patients undergoing complex cardiac surgical procedures.
Who may be able to join
- Neonates scheduled to undergo cardiac surgery where routine blood draws would be taken
- Consent signed by at least one legal guardian
Who cannot join
- Presence of any skin irritation or breakdown on the foot
- Foot impediments which would preclude proper placement of the sensor
- Clinical condition precluding the use of adhesive materials
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Medical Center at Mission Bay
San Francisco, California, 94158
About this study
Official title: Validate Pulse Oximeter Sensors in Neonates by Comparing Sensor Readings to Blood Samples During Cardiac Surgery
Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples during cardiac surgery.
Read the detailed description
Researchers at the University of California, San Francisco have developed methods that permit them to test multiple pulse oximeter sensors on neonates simultaneously during cardiac surgery. During this type of surgery, the arterial oxygen saturation changes over a wide range, providing an ideal arena for the assessment of neonatal pulse oximeter sensors at many levels of oxygen saturation. Several arterial blood gas samples are typically obtained during these procedures. Saturation of each arterial blood sample is determined by direct oximetry in a hemoximeter and this measurement is compared to the reading displayed on the pulse oximeter.
- Conditions
- Cardiac Surgery
- Being tested
- Pulse Oximeter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse OximeterDevice
Aulisa's non-invasive pulse oximeter sensor is applied to a foot of the neonate; an adhesive patch secures the sensor to the neonate.
| Study group | Role | What they receive |
|---|---|---|
| Test Subject | neonatal patients undergoing complex cardiac surgical procedures Receives: Device: Pulse Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of Pulse Oximeter Sensor in Neonates
Pulse Oximeters - Premarket Notifications Submissions [510(k)s] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013)
Measured: Data are collected anywhere from the beginning of surgery until the completion of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Feb 2019
- Primary completion5 May 2019
- Study completion10 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Aulisa Medical Devices Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Hung G Nguyen, MD, Principal investigator, UCSF Medical Center at Mission Bay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870373
- Sponsor's protocol ID
- 18-25904
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2019
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validate Pulse Oximeter Sensors in Neonates by Comparing Sensor Readings to Blood Samples During Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03870373
- Acronym / sponsor ID
- 18-25904
- Conditions
- Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Taiwan Aulisa Medical Devices Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 5 May 2019 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 12 Mar 2019 (actual)
- 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.
Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples during cardiac surgery.
Detailed description
Researchers at the University of California, San Francisco have developed methods that permit them to test multiple pulse oximeter sensors on neonates simultaneously during cardiac surgery. During this type of surgery, the arterial oxygen saturation changes over a wide range, providing an ideal arena for the assessment of neonatal pulse oximeter sensors at many levels of oxygen saturation. Several arterial blood gas samples are typically obtained during these procedures. Saturation of each arterial blood sample is determined by direct oximetry in a hemoximeter and this measurement is compared to the reading displayed on the pulse oximeter.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Subject | – | Device: Pulse Oximeterneonatal patients undergoing complex cardiac surgical procedures |
Who may qualify
- Ages
- 0 days to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonatal patients undergoing complex cardiac surgical procedures.
Key inclusion criteria (2 listed)
- Neonates scheduled to undergo cardiac surgery where routine blood draws would be taken
- Consent signed by at least one legal guardian
Key exclusion criteria (3 listed)
- Presence of any skin irritation or breakdown on the foot
- Foot impediments which would preclude proper placement of the sensor
- Clinical condition precluding the use of adhesive materials
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 |
|---|---|---|
| Pulse OximeterAulisa's non-invasive pulse oximeter sensor is applied to a foot of the neonate; an adhesive patch secures the sensor to the neonate. | Device | Test Subject |
Primary outcome
Performance of Pulse Oximeter Sensor in Neonates
Time frame: Data are collected anywhere from the beginning of surgery until the completion of the procedure
Pulse Oximeters - Premarket Notifications Submissions [510(k)s] Guidance For Industry and Food and Drug Administration Staff (issued: March 4, 2013)
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 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
Hung G Nguyen, MD principal investigator
UCSF Medical Center at Mission Bay
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 Cardiac Surgery, run by Taiwan Aulisa Medical Devices Technologies, Inc. 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 2 inclusion and 3 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 Apr 2021. 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?
Performance of Pulse Oximeter Sensor in Neonates (time frame: Data are collected anywhere from the beginning of surgery until the completion of the procedure). 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 Apr 2021.