A New Non-invasive Marker to Detect Silent Hypoxia in Patients Undergoing Cardiac Surgery

University Hospital, Strasbourg, France

Status: Unknown

Conditions: High-risk Surgical Patient; Cardiac Surgical Procedures; Anaerobic Threshold

Treatments: Device: Near infrared spectroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT01560611

5162

Details and patient eligibility

About

In patients undergoing cardiac surgery under cardiopulmonary bypass, some organs like brain and heart are preserved while others (skin, gut and skeletal muscle) are being underperfused. This phenomenon is related to silent peripheral vasoconstriction that is not clinically available but threatens end-organ perfusion and carries the risk of multi-organ failure. By measuring non-invasively the somatic-to-cerebral oxygen saturation gradient, the present study aims at detecting silent peroperative hypoperfusion episodes. The investigators hypothesize that gradient, measured during the surgical procedure, will predict the occurrence of anaerobic metabolism, ascertained by an elevation of blood lactate concentration, measured in intensive care unit.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 yo

• Cardiac surgical procedure under cardiopulmonary bypass

• High-risk surgical patient fulfilling one of the following items:

  • Euroscore >= 6
  • Ejection fraction < 40%
  • Creatinine clearance < 40mL/min
  • Pulmonary arterial pressure > 45mmHg

• Signed informed consent

• Social security affiliation

Exclusion criteria

• Emergency situation
• Patient on ECMO
• Pregnancy or lactation

Trial design

60 participants in 1 patient group

High-risk cardiac surgery patient

Treatment:

Device: Near infrared spectroscopy