HypoxiaNCT06634693
Controlled Desaturation Study for TipTraQ SpO2 Performance Validation
An observational study of Hypoxia, run by PranaQ Pte. Ltd. at 1 site in United States.
Trial summary
The objective is to validate the performance of SpO2 measurement of the TipTraQ by comparing it with measurement from an artery blood sample of a healthy volunteer in a controlled desaturation study. The overall framework of the validation process followed Annex EE.2 of ISO 80601-2-61:2019. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2023to 11 Oct 2023
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults without respiratory or heart diseases
Who may be able to join
- Participant must have the ability to understand and provide written informed consent
- A participant is an adult 18-50 years of age
- Participant must be willing and able to comply with study procedures and duration
- Participant is a non-smoker or who has not smoked within 2 days before the study.
Who cannot join
- Participant is considered as being morbidly obese (defined as BMI >39.5)
- Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears, forehead/skull, or other sensor sites would limit the ability to test sites needed for the study. Tattoos in the optical path would limit the ability to test sites needed for the study.
- Participants with known respiratory conditions
- Uncontrolled/severe asthma
- pneumonia/bronchitis
- shortness of breath / respiratory distress, unresolved respiratory or lung surgery, emphysema, COPD, lung disease
Show all 13Show fewer
- Recent COVID (last 2 months)
- Participants with self-reported heart or cardiovascular conditions
- chest pain (angina)
- heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
- previous heart attack
- blocked artery
- congestive heart failure (CHF)
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Medical Center at Parnassus
San Francisco, California, 94143
About this study
Official title: Accuracy of Pulse Oximeters with Profound Hypoxia
The objective is to validate the performance of SpO2 measurement of the TipTraQ by comparing it with measurement from an artery blood sample of a healthy volunteer in a controlled desaturation study. The overall framework of the validation process followed Annex EE.2 of ISO 80601-2-61:2019.
Read the detailed description
The TipTraQ, is a finger-based wearable for aiding OSA diagnosis at home that consists of a sensor placed on a fingertip. PPG data are produced by a reflective emitter and photodetector elements from one of the fingertips. TipTraQ Companion app can read and record the PPG signals from the TipTraQ Sensor and further transmit the data to TipTraQ Cloud.
The overall framework is a controlled desaturation study follows the Annex EE.2 of ISO 80601-2-61:2019. A radial arterial cannula was placed in each subject's left or right wrist for blood sampling and monitoring blood pressure. Each subject had two control blood samples taken at the beginning of each experiment while breathing room air. Hands with pulse oximeters were maintained motionless on arm boards. Hypoxia was then induced to different and stable levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, air, and carbon dioxide controlled by the study physician by adjusting gas flows with valves according to breath-by-breath estimates of oxygen saturation calculated from end-tidal PO2 and PCO2. Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds or until reference pulse oximeter readings were stable. During the procedure, the subject is under stationary status. Two arterial blood samples were then obtained approximately 30 seconds apart. Each stable plateau, therefore, was maintained for at least 60 seconds with SpO2 fluctuating by less than 2-3%. The plateaus were nominally at 100%, room air saturation, 93%, 90%, 87%, 85%, 82%, 80%, 77%, 75% and 70%. At least 200 data points were collected for each type of oximeter and probe combination studied.
- Conditions
- Hypoxia
- Keywords
- SpO2
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heathy adult | healthy adult without pulmonary or cardiovascular disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
SaO2
oxygen saturation of arterial blood sample measured by blood gas analysis
Measured: During the controlled desaturation study, within 1 day
SpO2
Peripheral blood oxygen saturation measured through plethysmography(PPG)
Measured: During the controlled desaturation study, within 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start10 Oct 2023
- Primary completion11 Oct 2023
- Study completion11 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- PranaQ Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Bickler, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634693
- Sponsor's protocol ID
- TipTraQ SpO2 validation study
- Other IDs
- 21-35637
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Pulse Oximeters with Profound Hypoxia
- ClinicalTrials.gov ID
- NCT06634693
- Acronym / sponsor ID
- TipTraQ SpO2 validation study
- Conditions
- Hypoxia
- Keywords
- SpO2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PranaQ Pte. Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 11 Oct 2023 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 10 Oct 2024 (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.
The objective is to validate the performance of SpO2 measurement of the TipTraQ by comparing it with measurement from an artery blood sample of a healthy volunteer in a controlled desaturation study. The overall framework of the validation process followed Annex EE.2 of ISO 80601-2-61:2019.
Detailed description
The TipTraQ, is a finger-based wearable for aiding OSA diagnosis at home that consists of a sensor placed on a fingertip. PPG data are produced by a reflective emitter and photodetector elements from one of the fingertips. TipTraQ Companion app can read and record the PPG signals from the TipTraQ Sensor and further transmit the data to TipTraQ Cloud.
The overall framework is a controlled desaturation study follows the Annex EE.2 of ISO 80601-2-61:2019. A radial arterial cannula was placed in each subject's left or right wrist for blood sampling and monitoring blood pressure. Each subject had two control blood samples taken at the beginning of each experiment while breathing room air. Hands with pulse oximeters were maintained motionless on arm boards. Hypoxia was then induced to different and stable levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, air, and carbon dioxide controlled by the study physician by adjusting gas flows with valves according to breath-by-breath estimates of oxygen saturation calculated from end-tidal PO2 and PCO2. Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds or until reference pulse oximeter readings were stable. During the procedure, the subject is under stationary status. Two arterial blood samples were then obtained approximately 30 seconds apart. Each stable plateau, therefore, was maintained for at least 60 seconds with SpO2 fluctuating by less than 2-3%. The plateaus were nominally at 100%, room air saturation, 93%, 90%, 87%, 85%, 82%, 80%, 77%, 75% and 70%. At least 200 data points were collected for each type of oximeter and probe combination studied.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heathy adult | – | –healthy adult without pulmonary or cardiovascular disease |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults without respiratory or heart diseases
Key inclusion criteria (4 listed)
- Participant must have the ability to understand and provide written informed consent
- A participant is an adult 18-50 years of age
- Participant must be willing and able to comply with study procedures and duration
- Participant is a non-smoker or who has not smoked within 2 days before the study.
Key exclusion criteria (13 listed)
- Participant is considered as being morbidly obese (defined as BMI >39.5)
- Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears, forehead/skull, or other sensor sites would limit the ability to test sites needed for the study. Tattoos in the optical path would limit the ability to test sites needed for the study.
- Participants with known respiratory conditions
- Uncontrolled/severe asthma
- pneumonia/bronchitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SaO2
Time frame: During the controlled desaturation study, within 1 day
oxygen saturation of arterial blood sample measured by blood gas analysis
SpO2
Time frame: During the controlled desaturation study, within 1 day
Peripheral blood oxygen saturation measured through plethysmography(PPG)
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 10 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Philip Bickler, MD, PhD principal investigator
University of California, San Francisco
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 Hypoxia, run by PranaQ Pte. Ltd. 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 4 inclusion and 13 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 10 Oct 2024. 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?
SaO2 (time frame: During the controlled desaturation study, within 1 day). The study lists 2 primary outcomes in all. 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 10 Oct 2024.