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

Heart; Dysfunction Postoperative, Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289470
• Other study ID #: QATP1881
• Status: Completed
• Phase: N/A
• First received: January 14, 2011
• Last updated: May 18, 2012
• Start date: January 2011
• Est. completion date: March 2012

Study information

• Verified date: May 2012
• Source: Nonin Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical 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. 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.

Description:

See Eligibility Criteria section

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart; Dysfunction Postoperative, Cardiac Surgery

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Nonin Medical, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of time Regional Oxygen Saturation (rSO2) values are registered during open heart surgery.		Completion of cardiovascular surgery	No
Secondary	Correlation between delirium outcome scale and Regional Oxygen Saturation (rSO2) values.		Patient discharge (on average 7 days)	No