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

• Conditions: Cardiac Surgical Procedures; High-risk Surgical Patient; Anaerobic Threshold
• Interventions: Device: Near infrared spectroscopy

• Registration Number: NCT01560611
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-03
• Study Start: 2012-03
• Study First Submitted: 2012-03-20
• Study First Submitted QC: 2012-03-21
• Last Update Submitted: 2012-03-21
• Study First Posted: 2012-03-22
• Last Update Posted: 2012-03-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High-risk cardiac surgery patient	Near infrared spectroscopy	-

Trial Locations

Locations (1)

Pôle d'anesthésie réanimation - Nouvel Hôpital Civil; 🇫🇷 Strasbourg, France