Cardiac Bypass PatientsNCT01655940
Cerebral Oximeter Comparison Study
An observational study of Cardiac Bypass Patients, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
In this prospective study to try to standardize the care for patients, the investigators are planning to compare two cerebral oximeters currently in use at NCH in terms of their accuracy in determining the cerebral oxygen saturation as determined by jugular bulb oxygen saturation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Bypass Patients
- What is being tested?
- Somanetics cerebral oximeter and CASMED cerebral oximeter
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2011
- 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: Cardiac bypass patients having surgery at Nationwide Children's Hospital
Who may be able to join
- Patients undergoing cardiac surgery
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Comparison of the FORE-SITE and INVOS Cerebral Oximeters During Cardiac Surgery
In this prospective study to try to standardize the care for patients, the investigators are planning to compare two cerebral oximeters currently in use at NCH in terms of their accuracy in determining the cerebral oxygen saturation as determined by jugular bulb oxygen saturation. Also, the investigators will compare these devices in terms of their response to changes in hemodynamics that occur during cardiac surgery.
- Conditions
- Cardiac Bypass Patients
- Being tested
- Somanetics cerebral oximeter, CASMED cerebral oximeter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somanetics cerebral oximeterDevice
Somanetics cerebral oximeter
CASMED cerebral oximeterDevice
CASMED cerebral oximeter
| Study group | Role | What they receive |
|---|---|---|
| Cardiac bypass patients | Not described Receives: Device: Somanetics cerebral oximeter; Device: CASMED cerebral oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation
cannulation, decannulation, hemodynamic instability
Measured: during surgery - Day 1
Secondary outcomes (1)
Mean arterial pressure
cannulation, decannulation, hemodynamic instability
Measured: during surgery - Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startMay 2011
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Bypass PatientsStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aymen N Naguib, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655940
- Sponsor's protocol ID
- IRB11-00256
- Status last verified
- Jul 2012
- First submitted
- 17 May 2011
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the FORE-SITE and INVOS Cerebral Oximeters During Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01655940
- Acronym / sponsor ID
- IRB11-00256
- Conditions
- Cardiac Bypass Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Aug 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.
In this prospective study to try to standardize the care for patients, the investigators are planning to compare two cerebral oximeters currently in use at NCH in terms of their accuracy in determining the cerebral oxygen saturation as determined by jugular bulb oxygen saturation. Also, the investigators will compare these devices in terms of their response to changes in hemodynamics that occur during cardiac surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac bypass patients | – | Device: Somanetics cerebral oximeter, Device: CASMED cerebral oximeter |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cardiac bypass patients having surgery at Nationwide Children's Hospital
Key inclusion criteria (1 listed)
- Patients undergoing cardiac surgery
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Somanetics cerebral oximeterSomanetics cerebral oximeter | Device | Cardiac bypass patients |
| CASMED cerebral oximeterCASMED cerebral oximeter | Device | Cardiac bypass patients |
Primary outcome
Oxygen saturation
Time frame: during surgery - Day 1
cannulation, decannulation, hemodynamic instability
1 secondary outcome
Mean arterial pressure
Time frame: during surgery - Day 1
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 2 Aug 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiac Bypass Patients, run by Nationwide Children's Hospital 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 1 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 2 Aug 2012. 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?
Oxygen saturation (time frame: during surgery - Day 1). 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 2 Aug 2012.