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Clinical Trials/NCT02207296
NCT02207296
Completed
Phase 3

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

University Hospital, Caen1 site in 1 country440 target enrollmentFebruary 2015
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ConditionsHip ArthroplastyKnee ArthroplastyGeneral Anesthesia

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Hip Arthroplasty
Sponsor
University Hospital, Caen
Enrollment
440
Locations
1
Primary Endpoint
Length of hospital stay after knee or hip arthroplasty
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
November 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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
  • •Cardiac arrythmia
  • •Use of another hemodynamic monitoring during surgery

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Length of hospital stay after knee or hip arthroplasty

Time Frame: 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 Outcomes

  • 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)
  • 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))

Study Sites (1)

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