Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery
OPVI
1 other identifier
interventional
440
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2015
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2014
CompletedFirst Posted
Study publicly available on registry
August 4, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedMay 15, 2019
May 1, 2019
2 years
June 17, 2014
May 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Length of hospital stay after knee or hip arthroplasty
Surgeons, blinded to the group allocation, are the postoperative care providers who decide the length of hospital stay.
Real length of hospital stay expressed as number of day (maximum 60 days)
Secondary Outcomes (5)
Troponin value
Postoperative Day 1 and Day 3
Creatinine value
Postoperative Day 1 and Day 3
Arterial Lactate
1 hour after end of surgery
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)
Other Outcomes (1)
Medico economic evaluation
Participants will be followed for the duration of hospital stay, an expected average of 1 week, until postoperative day 60
Study Arms (2)
PVI group
OTHERFluid optimisation using PVI
Control group
NO INTERVENTIONStandard care using a hemodynamic protocol during general anesthesia
Interventions
Eligibility Criteria
You may qualify if:
- Age \> 18 years
- Indication to a knee or hip arthroplasty under general anesthesia
- Sinusal rhythm
- Pregnant women
- Black skin
- Dialysis
- Cardiac arrythmia
- Sepsis
- Use of another hemodynamic monitoring during surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Caen University Hospital
Caen, 14 000, France
Related Publications (1)
Fischer MO, Daccache G, Lemoine S, Tavernier B, Compere V, Hulet C, Bouchakour CE, Canevet C, Gerard JL, Guittet L, Lorne E, Hanouz JL, Parienti JJ. The OPVI trial - perioperative hemodynamic optimization using the plethysmographic variability index in orthopedic surgery: study protocol for a multicenter randomized controlled trial. Trials. 2015 Nov 4;16:503. doi: 10.1186/s13063-015-1020-7.
PMID: 26537815DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2014
First Posted
August 4, 2014
Study Start
February 1, 2015
Primary Completion
February 1, 2017
Study Completion
November 1, 2017
Last Updated
May 15, 2019
Record last verified: 2019-05