Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery (OPVI)

Caen University Hospital

Status and phase: Completed; Phase 3

Conditions: Knee Arthroplasty; General Anesthesia; Hip Arthroplasty

Treatments: Device: Plethysmographic variability index

Study type: Interventional

Funder types: Other

Identifiers

NCT02207296

2014-A00330-47

Details and patient eligibility

About

The purpose of this study is to determine whether an operative hemodynamic optimization using the plethysmographic variability index during orthopedic surgery could decrease the length of hospital stay and the postoperative morbidity.

Enrollment: 440 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age > 18 years
• Indication to a knee or hip arthroplasty under general anesthesia
• Sinusal rhythm

Non Inclusion Criteria:

• Pregnant women
• Black skin
• Dialysis
• Cardiac arrythmia
• Sepsis
• Use of another hemodynamic monitoring during surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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440 participants in 2 patient groups

PVI group

Other group

Description:

Fluid optimisation using PVI

Treatment:

Device: Plethysmographic variability index

Control group

No Intervention group

Description:

Standard care using a hemodynamic protocol during general anesthesia