Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery

Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery : a Multicentric Prospective Randomized Controlled Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02207296

Acronym

OPVI

Enrollment

440

Registered

2014-08-04

Start date

2015-02-28

Completion date

2017-11-30

Last updated

2019-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia, Hip Arthroplasty, Knee Arthroplasty

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.

Interventions

DEVICEPlethysmographic variability index

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Troponin value	Postoperative Day 1 and Day 3	—
Creatinine value	Postoperative Day 1 and Day 3	—
Postoperative cardiac complications	Participants will be followed for the duration of hospital stay, an expected average of 1 week, until postoperative day 60	—
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
Arterial Lactate	1 hour after end of surgery	—

Other

Measure	Time frame
Medico economic evaluation	Participants will be followed for the duration of hospital stay, an expected average of 1 week, until postoperative day 60

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026