Subjects With an Existing Intra-arterial LineNCT01797250
Pulse Oximetry_Performance Testing- PCBA-1 (Printed Circuit Board Assembly) NEO/PEDS
An observational study of Subjects With an Existing Intra-arterial Line, run by Medtronic - MITG at 2 sites in United States.
Trial summary
To determine accuracy specifications of the pulse oximeter in the NEO/PEDS subject population Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjects With an Existing Intra-arterial Line
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2013to Jul 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 1 month to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study population will include male and female pediatric and neonatal patients who meet the specified sensor weight requirements with an existing intra-arterial line, typically found in hospital intensive care areas. Subjects of all racial and ethnic backgrounds may be included in the studies.
Who may be able to join
- Subject or legal guardian is willing and able to sign informed consent prior to study initiation.
- Subject is able to participate for the duration of the evaluation. In most instances, the length of the study will not exceed twenty-four hours.
- Subject satisfies a specified sensor requirement (see Table 1).
- Requires use of an intra-arterial line for medical reasons such as continuous blood pressure monitoring or frequent arterial blood draws.
- Subject is able to accommodate multiple sensors.
- Neonatal subjects up to 1 month of age or Pediatric subjects 1 month up to 18 years old.
Who cannot join
- Subjects that have an existing health condition, in which the investigators determine that safe or accurate oximetry measures may not be obtained at the areas where the pulse oximetry sensor could be placed, will not be included in the study. For example, anyone with burns, abrasions or surface lesions on the contact areas would be excluded.
- Any subject whose treatment or condition would be compromised if they were to participate in this study and any patient whose use of a pulse oximeter and sensor would present a potential for serious risk to health, safety, or welfare.
- Subject has severe contact allergies that may react to standard adhesive materials found in pulse oximetry sensors.
- Subject cannot be reliably monitored with a pulse oximeter as a result of inadequate pulsatile signals.
- Subject has had a procedure using injected intravascular dyes within 24 hours preceding testing
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital- Los Angeles
Los Angeles, California, 90027
Wasatch Neonatal
Orem, Utah, 84057
About this study
Official title: Neonatal and Pediatric Studies Using a Bedside Respiratory Patient Monitoring System With the Functional Patient Monitoring PCBA-1
To determine accuracy specifications of the pulse oximeter in the NEO/PEDS subject population
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 Accuracy (percentage of blood oxygen saturation)
Measured: Planned duration of study was up to 12 months. Duration of subject participation: 1-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects With an Existing Intra-arterial LineStudies 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
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797250
- Sponsor's protocol ID
- COVMOPR0308
- Status last verified
- Dec 2013
- First submitted
- 20 Feb 2013
- Last updated
- 6 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal and Pediatric Studies Using a Bedside Respiratory Patient Monitoring System With the Functional Patient Monitoring PCBA-1
- ClinicalTrials.gov ID
- NCT01797250
- Acronym / sponsor ID
- COVMOPR0308
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 22 Feb 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 determine accuracy specifications of the pulse oximeter in the NEO/PEDS subject population
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population will include male and female pediatric and neonatal patients who meet the specified sensor weight requirements with an existing intra-arterial line, typically found in hospital intensive care areas. Subjects of all racial and ethnic backgrounds may be included in the studies.
Key inclusion criteria (6 listed)
- Subject or legal guardian is willing and able to sign informed consent prior to study initiation.
- Subject is able to participate for the duration of the evaluation. In most instances, the length of the study will not exceed twenty-four hours.
- Subject satisfies a specified sensor requirement (see Table 1).
- Requires use of an intra-arterial line for medical reasons such as continuous blood pressure monitoring or frequent arterial blood draws.
- Subject is able to accommodate multiple sensors.
Key exclusion criteria (5 listed)
- Subjects that have an existing health condition, in which the investigators determine that safe or accurate oximetry measures may not be obtained at the areas where the pulse oximetry sensor could be placed, will not be included in the study. For example, anyone with burns, abrasions or surface lesions on the contact areas would be excluded.
- Any subject whose treatment or condition would be compromised if they were to participate in this study and any patient whose use of a pulse oximeter and sensor would present a potential for serious risk to health, safety, or welfare.
- Subject has severe contact allergies that may react to standard adhesive materials found in pulse oximetry sensors.
- Subject cannot be reliably monitored with a pulse oximeter as a result of inadequate pulsatile signals.
- Subject has had a procedure using injected intravascular dyes within 24 hours preceding testing
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
SpO2 Accuracy (percentage of blood oxygen saturation)
Time frame: Planned duration of study was up to 12 months. Duration of subject participation: 1-24 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 6 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subjects With an Existing Intra-arterial Line, run by Medtronic - MITG at 2 sites 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 6 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 6 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
SpO2 Accuracy (percentage of blood oxygen saturation) (time frame: Planned duration of study was up to 12 months. Duration of subject participation: 1-24 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 6 Dec 2013.