Clinical Assessment of Nonin 7600 Near Infrared Spectroscopy (NIRS) Tissue Oximetry During Cardiovascular Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart; Dysfunction Postoperative, Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

See Eligibility Criteria section

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Percent of time Regional Oxygen Saturation (rSO2) values are registered during open heart surgery.

Time frame: Completion of cardiovascular surgery

Secondary outcomes

Correlation between delirium outcome scale and Regional Oxygen Saturation (rSO2) values.

Time frame: Patient discharge (on average 7 days)

Sponsors and collaborators

Lead sponsor

Nonin Medical, Inc

Industry

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Feb 3, 2011
Registry last updated: May 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed