Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery

Phase 3

Completed

• Conditions: Knee Arthroplasty; Hip Arthroplasty; General Anesthesia
• Interventions: Device: Plethysmographic variability index

• Registration Number: NCT02207296
• Lead Sponsor: University Hospital, Caen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-07-31
• Study First Posted: 2014-08-04
• Study Start: 2015-02
• Primary Completion: 2017-02
• Study Completion: 2017-11
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVI group	Plethysmographic variability index	Fluid optimisation using PVI

Primary Outcome Measures

Name	Time	Method
Length of hospital stay after knee or hip arthroplasty	Real length of hospital stay expressed as number of day (maximum 60 days)	Surgeons, blinded to the group allocation, are the postoperative care providers who decide the length of hospital stay.

Secondary Outcome Measures

Name	Time	Method
Postoperative cardiac complications	Participants will be followed for the duration of hospital stay, an expected average of 1 week, until postoperative day 60
Troponin value	Postoperative Day 1 and Day 3
Arterial Lactate	1 hour after end of surgery
Theorical length of hospital stay after knee or hip arthroplasty	Theorical length of hospital stay expressed as number of day (maximum 60 days)	Evaluation twice per day starting day 3 until up day 60. A check list was used by an independant investigator to define the theorical date of end hospitalisation, from day 3 until day 60
Creatinine value	Postoperative Day 1 and Day 3

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, France