Blood Gas Analyte ValuesAnalyze ABSNCT01935284
Evaluation of Blood Gas Syringes
An observational study of Blood Gas Analyte Values, run by Smiths Medical, ASD, Inc. at 1 site in United States.
Trial summary
To assess the interchangeability and agreement between measurements from three blood gas syringes for the collection of blood for the analysis of multiple analytes as measured by differing manufacturers' multi-parameter analyzers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Gas Analyte Values
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jun 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Volunteers
Who may be able to join
- 18 years of age or older
- Willing and able to independently sign an English Informed Consent
- Have adequate veins for sampling blood from both right and left upper extremities
Who cannot join
- Currently taking anti-coagulation medication
- Have a known bloodborne disease or bleeding tendency
- Have a known fear or adverse reaction to needles or blood
- Women who are pregnant or nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Market Study Evaluating Analyzer Readings of Multiple Arterial Blood Gas Syringes
To assess the interchangeability and agreement between measurements from three blood gas syringes for the collection of blood for the analysis of multiple analytes as measured by differing manufacturers' multi-parameter analyzers.
Read the detailed description
This is a prospective, randomized, post-market study using fresh blood for analysis that is obtained from healthy subject volunteers. Trained phlebotomists will collect blood samples from subjects after confirmation of eligibility criteria. Blood samples will be drawn to fill all study syringe types in a randomized order. Each syringe type will be drawn per subject to analyze each of the available blood parameters in duplicate using three different multi-parameter analyzers. The analytes tested will vary per analyzer capabilities. All blood draws and analyte testing will be performed at an independent laboratory. The study is to confirm that all of the syringes tested provide consistent readings when analyzed using the most common multi-parameter analyzers used in hospital laboratories.
- Conditions
- Blood Gas Analyte Values
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 |
|---|---|---|
| Healthy Volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in analyte values obtained from three different blood gas syringes for each analyzer tested
For each of the analytes that are tested, the analyte values from each of the three (3) syringe types tested will be compared for each of the three (3) multi-parameter analyzers. Average values for each analyte per patient, syringe and analyzer will be used for the comparison of syringes for each analyzer.
Measured: Blood analysis within 30 minutes of draw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Gas Analyte ValuesStudies 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
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smiths Medical, ASD, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bionostics
- Responsible party
- Sponsor
- Investigators
- Lisa Cifaldi, BS, RRT, Principal investigator, Smiths Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935284
- Sponsor's protocol ID
- Analyze ABS
- Acronym
- Analyze ABS
- Status last verified
- Aug 2013
- First submitted
- 26 Jun 2013
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Study Evaluating Analyzer Readings of Multiple Arterial Blood Gas Syringes
- ClinicalTrials.gov ID
- NCT01935284
- Acronym / sponsor ID
- Analyze ABS / Analyze ABS
- Conditions
- Blood Gas Analyte Values
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Smiths Medical, ASD, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Bionostics
- Study start
- Jun 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 5 Sep 2013 (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.
To assess the interchangeability and agreement between measurements from three blood gas syringes for the collection of blood for the analysis of multiple analytes as measured by differing manufacturers' multi-parameter analyzers.
Detailed description
This is a prospective, randomized, post-market study using fresh blood for analysis that is obtained from healthy subject volunteers. Trained phlebotomists will collect blood samples from subjects after confirmation of eligibility criteria. Blood samples will be drawn to fill all study syringe types in a randomized order. Each syringe type will be drawn per subject to analyze each of the available blood parameters in duplicate using three different multi-parameter analyzers. The analytes tested will vary per analyzer capabilities. All blood draws and analyte testing will be performed at an independent laboratory. The study is to confirm that all of the syringes tested provide consistent readings when analyzed using the most common multi-parameter analyzers used in hospital laboratories.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Volunteers
Key inclusion criteria (3 listed)
- 18 years of age or older
- Willing and able to independently sign an English Informed Consent
- Have adequate veins for sampling blood from both right and left upper extremities
Key exclusion criteria (4 listed)
- Currently taking anti-coagulation medication
- Have a known bloodborne disease or bleeding tendency
- Have a known fear or adverse reaction to needles or blood
- Women who are pregnant or nursing
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
Differences in analyte values obtained from three different blood gas syringes for each analyzer tested
Time frame: Blood analysis within 30 minutes of draw
For each of the analytes that are tested, the analyte values from each of the three (3) syringe types tested will be compared for each of the three (3) multi-parameter analyzers. Average values for each analyte per patient, syringe and analyzer will be used for the comparison of syringes for each analyzer.
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 5 Sep 2013.
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.
Lisa Cifaldi, BS, RRT principal investigator
Smiths Medical
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 Blood Gas Analyte Values, run by Smiths Medical, ASD, 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 3 inclusion and 4 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 5 Sep 2013. 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?
Differences in analyte values obtained from three different blood gas syringes for each analyzer tested (time frame: Blood analysis within 30 minutes of draw). 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 5 Sep 2013.