Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery

General Anesthesia Clinical Trial

— OPVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02207296
• Other study ID #: 2014-A00330-47
• Status: Completed
• Phase: Phase 3
• Start date: February 2015
• Est. completion date: November 2017

Study information

• Verified date: May 2019
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: November 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• General Anesthesia
• Hip Arthroplasty
• Knee Arthroplasty

Intervention

Device:
• Plethysmographic variability index

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medico economic evaluation		Participants will be followed for the duration of hospital stay, an expected average of 1 week, until postoperative day 60
Primary	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	Troponin value		Postoperative Day 1 and Day 3
Secondary	Creatinine value		Postoperative Day 1 and Day 3
Secondary	Arterial Lactate		1 hour after end of surgery
Secondary	Postoperative cardiac complications		Participants will be followed for the duration of hospital stay, an expected average of 1 week, until postoperative day 60
Secondary	Theorical length of hospital stay after knee or hip arthroplasty	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	Theorical length of hospital stay expressed as number of day (maximum 60 days)