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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01289470

Enrollment

Registered

2011-02-03

Start date

2011-01-31

Completion date

2012-03-31

Last updated

2012-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart; Dysfunction Postoperative, Cardiac Surgery

Keywords

NIRS Technology, Cardiovascular surgery, valvular surgery with cardiopulmonary bypass

Brief 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. 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percent of time Regional Oxygen Saturation (rSO2) values are registered during open heart surgery.	Completion of cardiovascular surgery

Secondary

Measure	Time frame
Correlation between delirium outcome scale and Regional Oxygen Saturation (rSO2) values.	Patient discharge (on average 7 days)

Countries

United States

Outcome results