Healthy VolunteersNCT01583634
Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin
An observational study of Healthy Volunteers, run by Mespere Lifesciences Inc. at 1 site in United States.
Trial summary
Accuracy of the oximeter. Read more about this study
- Who is it for?
- Ages 21 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Mespere Oximeter and Radiometer OSM-3 Co-Oximeter
- Type of treatment
- Medical device
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Oct 2014
- 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 21 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers between the ages of 21 and 49 years of either gender, and a range of skin tones
Who may be able to join
- Healthy volunteers between the ages of 21 and 49 years of either gender
Who cannot join
- smokers
- pregnancy
- any chronic medical condition including heart disease, hypertension, pulmonary disease, liver or kidney disease
- obesity
- evidence of abnormal neck vein anatomy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco, Induced Hypoxia Lab
San Francisco, California, 94143
About this study
Accuracy of the oximeter.
Read the detailed description
The conventional pulse oximeter has been a standard in clinical care for non-invasive hemodynamic monitoring, which only measures the arterial blood oxygenation. There are many clinical situations where tissue hypoxia may exist despite normal values obtained by conventional pulse oximeter. This can be cause by inadequate monitoring of oxygen demand (i.e. venous oxygen saturation) of the tissues.
The existing method for venous blood oxygenation monitored is either through an invasive fiber optic catheter, or intermittently by blood sampling and CO-oximetry. However, catheterization can be costly and can include inherent risks. Therefore, due to the inherent risks of catheterization, venous oximetry is limited only to those critically ill patients. The clinical application of venous oximetry is numerous, including severe sepsis and septic shock, severe trauma and hemorrhagic shock, and heart failure and cardiac arrest.
More complete information on patient hemodynamics can be provided by non-invasively monitoring of venous blood oxygenation.
- Conditions
- Healthy Volunteers
- Being tested
- Mespere Oximeter, Radiometer OSM-3 Co-Oximeter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mespere OximeterDevice
Mespere oximeter provides non-invasive venous blood oxygen saturation.
Radiometer OSM-3 Co-OximeterDevice
OSM-3, a Radiometer manufactured hemoximeter, is intended for the photometric determination of hemoglobin.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | 9 subjects (male and female) Receives: Device: Mespere Oximeter; Device: Radiometer OSM-3 Co-Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous Oxygen Saturation Accuracy Verification against Co-Oximeter
Measured: approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startSep 2014
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mespere Lifesciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip E Bickler, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583634
- Sponsor's protocol ID
- MLS STP-9100001
- Status last verified
- Oct 2014
- First submitted
- 12 Apr 2012
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Oximeters With Hypoxia and Methemoglobin or Carboxyhemoglobin
- ClinicalTrials.gov ID
- NCT01583634
- Acronym / sponsor ID
- MLS STP-9100001
- Conditions
- Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mespere Lifesciences Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 24 Apr 2012 (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.
Accuracy of the oximeter.
Detailed description
The conventional pulse oximeter has been a standard in clinical care for non-invasive hemodynamic monitoring, which only measures the arterial blood oxygenation. There are many clinical situations where tissue hypoxia may exist despite normal values obtained by conventional pulse oximeter. This can be cause by inadequate monitoring of oxygen demand (i.e. venous oxygen saturation) of the tissues.
The existing method for venous blood oxygenation monitored is either through an invasive fiber optic catheter, or intermittently by blood sampling and CO-oximetry. However, catheterization can be costly and can include inherent risks. Therefore, due to the inherent risks of catheterization, venous oximetry is limited only to those critically ill patients. The clinical application of venous oximetry is numerous, including severe sepsis and septic shock, severe trauma and hemorrhagic shock, and heart failure and cardiac arrest.
More complete information on patient hemodynamics can be provided by non-invasively monitoring of venous blood oxygenation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Device: Mespere Oximeter, Device: Radiometer OSM-3 Co-Oximeter9 subjects (male and female) |
Who may qualify
- Ages
- 21 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers between the ages of 21 and 49 years of either gender, and a range of skin tones
Key inclusion criteria (1 listed)
- Healthy volunteers between the ages of 21 and 49 years of either gender
Key exclusion criteria (5 listed)
- smokers
- pregnancy
- any chronic medical condition including heart disease, hypertension, pulmonary disease, liver or kidney disease
- obesity
- evidence of abnormal neck vein anatomy
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 |
|---|---|---|
| Mespere OximeterMespere oximeter provides non-invasive venous blood oxygen saturation. | Device | Healthy volunteers |
| Radiometer OSM-3 Co-OximeterOSM-3, a Radiometer manufactured hemoximeter, is intended for the photometric determination of hemoglobin. | Device | Healthy volunteers |
Primary outcome
Venous Oxygen Saturation Accuracy Verification against Co-Oximeter
Time frame: approximately 1 hour
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 3 Oct 2014.
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Screening Protocol
Pain
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 E 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 Healthy Volunteers, run by Mespere Lifesciences 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 1 inclusion and 5 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 3 Oct 2014. 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?
Venous Oxygen Saturation Accuracy Verification against Co-Oximeter (time frame: approximately 1 hour). 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 3 Oct 2014.