Cardiopulmonary BypassNCT00854048
The Performance of Pulse Oximeters in Pediatric Patients With Low Oxygen Saturation Levels
An observational study of Cardiopulmonary Bypass, run by Ulf Borg at 1 site in China.
Trial summary
Evaluate pulse oximeters with children after cardiopulmonary by-pass under low Oxygen conditions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiopulmonary Bypass
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- Dec 2007to Jul 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric patients after cardiopulmonary by-pass in the PICU.
Who may be able to join
- Include pediatric patients with a baseline Sa02 < 90% and no contraindications to using an adhesive sensor.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Chidren's Hospital
Chongqing University of Medical Sciences, Chongqing Municipality
About this study
Official title: The Performance of Nellcor OxiMax N-560 and Masimo SET Radical Pulse Oximeters in Pediatric Patients With Low Oxygen Saturation Levels
Evaluate pulse oximeters with children after cardiopulmonary by-pass under low Oxygen conditions.
- Conditions
- Cardiopulmonary Bypass
- Keywords
- Pediatric, Oxygen Saturation, Cardiopulmonary bypass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startDec 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary BypassStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulf Borg
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor-investigator, Ulf Borg, Medtronic - MITG
- Investigators
- Xu Feng, MD, Principal investigator, Children's Hospital Congqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854048
- Sponsor's protocol ID
- M112
- Status last verified
- Nov 2016
- First submitted
- 27 Feb 2009
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Performance of Nellcor OxiMax N-560 and Masimo SET Radical Pulse Oximeters in Pediatric Patients With Low Oxygen Saturation Levels
- ClinicalTrials.gov ID
- NCT00854048
- Acronym / sponsor ID
- M112
- Conditions
- Cardiopulmonary Bypass
- Keywords
- Pediatric, Oxygen Saturation, Cardiopulmonary bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ulf BorgIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic - MITG
- Study start
- Dec 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 2 Mar 2009 (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.
Evaluate pulse oximeters with children after cardiopulmonary by-pass under low Oxygen conditions.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric patients after cardiopulmonary by-pass in the PICU.
Key inclusion criteria (1 listed)
- Include pediatric patients with a baseline Sa02 < 90% and no contraindications to using an adhesive sensor.
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 30 Nov 2016.
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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.
Xu Feng, MD principal investigator
Children's Hospital Congqing Medical University
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 Cardiopulmonary Bypass, run by Ulf Borg at 1 site in China.
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 0 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 30 Nov 2016. 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 China. 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.
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 30 Nov 2016.