Heart; Dysfunction Postoperative, Cardiac SurgeryNCT01289470
Clinical Assessment of Nonin 7600 Near Infrared Spectroscopy (NIRS) Tissue Oximetry During Cardiovascular Surgery
An observational study of Heart; Dysfunction Postoperative, Cardiac Surgery, run by Nonin Medical, Inc at 1 site in United States.
Trial summary
An observational study designed to evaluate the performance of a new Near Infrared Spectroscopy (NIRS) tissue oximeter device in the clinical setting, including a cerebral sensor and peripheral sensor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart; Dysfunction Postoperative, Cardiac Surgery
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Mar 2012
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing Coronary Artery Bypass Graft (CABG) and valvular surgery with cardiopulmonary bypass
Who may be able to join
- Age 18 years or older
- Weigh at least 40 kg
- Undergoing Coronary Artery Bypass Graft (CABG) and/or valvular surgery requiring the use of Cardio Pulmonary Bypass (CPB) or Left Ventricular Assist Device (LVAD), inclusive of any concomitant procedure
- Willing and able to provide informed consent
- Able to communicate and read in English
Who cannot join
- Emergency procedure such that informed consent may not be obtained
- Known cognitive impairment, history of delirium or dementia
- Known hemodialysis or fistula graft
- Delirium Observation Score (DOS) Score of >6 prior to surgery
- Pre-existing skin condition at the site of sensor application (e.g. eczema, dermatitis)
- Any known contraindication or sensitivity to the cerebral oximeter sensor
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
An observational study designed to evaluate the performance of a new Near Infrared Spectroscopy (NIRS) tissue oximeter device in the clinical setting, including a cerebral sensor and peripheral sensor. Fifty patients who are undergoing open-heart surgery will be enrolled and tissue oximetry measurement will be collected throughout the surgical procedure and for up to 24 hours following surgery. Tissue oximeter measurement of the brain and skeletal tissue will be added to the standard intra-operative patient monitoring. Measures of delirium will be collected using a standardized questionnaire. The relationship between cerebral oximetry measures and delirium scores will be explored.
Read the detailed description
See Eligibility Criteria section
- Keywords
- NIRS Technology, Cardiovascular surgery, valvular surgery with cardiopulmonary bypass
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of time Regional Oxygen Saturation (rSO2) values are registered during open heart surgery.
Measured: Completion of cardiovascular surgery
Secondary outcomes (1)
Correlation between delirium outcome scale and Regional Oxygen Saturation (rSO2) values.
Measured: Patient discharge (on average 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart; Dysfunction Postoperative, Cardiac SurgeryStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nonin Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Solomon Aronson, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289470
- Sponsor's protocol ID
- QATP1881
- Status last verified
- May 2012
- First submitted
- 14 Jan 2011
- Last updated
- 21 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Nonin 7600 Near Infrared Spectroscopy (NIRS) Tissue Oximetry During Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT01289470
- Acronym / sponsor ID
- QATP1881
- Keywords
- NIRS Technology, Cardiovascular surgery, valvular surgery with cardiopulmonary bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nonin Medical, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 3 Feb 2011 (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.
An observational study designed to evaluate the performance of a new Near Infrared Spectroscopy (NIRS) tissue oximeter device in the clinical setting, including a cerebral sensor and peripheral sensor. Fifty patients who are undergoing open-heart surgery will be enrolled and tissue oximetry measurement will be collected throughout the surgical procedure and for up to 24 hours following surgery. Tissue oximeter measurement of the brain and skeletal tissue will be added to the standard intra-operative patient monitoring. Measures of delirium will be collected using a standardized questionnaire. The relationship between cerebral oximetry measures and delirium scores will be explored.
Detailed description
See Eligibility Criteria section
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing Coronary Artery Bypass Graft (CABG) and valvular surgery with cardiopulmonary bypass
Key inclusion criteria (5 listed)
- Age 18 years or older
- Weigh at least 40 kg
- Undergoing Coronary Artery Bypass Graft (CABG) and/or valvular surgery requiring the use of Cardio Pulmonary Bypass (CPB) or Left Ventricular Assist Device (LVAD), inclusive of any concomitant procedure
- Willing and able to provide informed consent
- Able to communicate and read in English
Key exclusion criteria (6 listed)
- Emergency procedure such that informed consent may not be obtained
- Known cognitive impairment, history of delirium or dementia
- Known hemodialysis or fistula graft
- Delirium Observation Score (DOS) Score of >6 prior to surgery
- Pre-existing skin condition at the site of sensor application (e.g. eczema, dermatitis)
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
Percent of time Regional Oxygen Saturation (rSO2) values are registered during open heart surgery.
Time frame: Completion of cardiovascular surgery
1 secondary outcome
Correlation between delirium outcome scale and Regional Oxygen Saturation (rSO2) values.
Time frame: Patient discharge (on average 7 days)
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 21 May 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.
Solomon Aronson, MD principal investigator
Duke Health
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 Heart; Dysfunction Postoperative, Cardiac Surgery, run by Nonin Medical, 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 5 inclusion and 6 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 21 May 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?
Percent of time Regional Oxygen Saturation (rSO2) values are registered during open heart surgery. (time frame: Completion of cardiovascular surgery). 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 21 May 2012.