Peripheral Four-wavelength Near-infrared Spectroscopy Measurement: a Comparison Between EQUANOX and O3 in Cardiac Surgery

Conventional Cardiac Surgery With Bypass Clinical Trial

— NIRS-8  

Official title:

Peripheral Four-wavelength Near-infrared Spectroscopy Measurement: a Comparison Between EQUANOX and O3 in Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847273
• Other study ID #: 69HCL16_0502
• Status: Completed
• Phase: N/A
• First received: July 25, 2016
• Last updated: July 27, 2016
• Start date: September 2015
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial Summary

Near-infrared spectroscopy (NIRS) is a continuous and non-invasive technology that measures regional tissue oxygen saturation (rSO2). Whatever the anatomical site of measurement, a normal value of rSO2 would suggest a good adequacy between oxygen supply and consumption at the regional level. Beside the trend ability of previous 2 or 3-wavelength devices, a new 4-wavelength generation of NIRS monitors which could reliably assess real-time absolute values of rSO2 is now available. The investigators aimed to compare peripheral absolute rSO2 values given by the 4-wavelength EQUANOX device 7600 (Nonin Medical, Plymouth, Mn) and the new O3 device (Masimo, Irvine, CA) during conventional cardiac surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years

• Scheduled for conventional elective cardiac surgery with cardiopulmonary bypass

• Hospitalized in the Teaching University Hospital Louis Pradel (Lyon, France)

• Patient agreement

Exclusion Criteria:

• Age<18 years

• Black skin

• Emergencies

• Patient refusal

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Conventional Cardiac Surgery With Bypass

Locations

Country	Name	City	State
France	Hôpital Cardiovasculaire et Pneumologique Louis Pradel, Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral absolute rSO2 values	Peripheral absolute rSO2 values given by the 4-wavelength EQUANOX device 7600 (Nonin Medical, Plymouth, Mn) and the new O3 device (Masimo, Irvine, CA) during conventional cardiac surgery.	at conventional cardiac surgery (Day 1)	No
Secondary	Arterial pressure	General monitoring	at conventional cardiac surgery (Day 1)	No
Secondary	heart rate	General monitoring	at conventional cardiac surgery (Day 1)	No
Secondary	pulse oxygen saturation	General monitoring	at conventional cardiac surgery (Day 1)	No
Secondary	bispectral index	General monitoring	at conventional cardiac surgery (Day 1)	No
Secondary	Inotrope drugs doses		at conventional cardiac surgery (Day 1)	No