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Completed

NCT Number: NCT02207296

Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery

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.

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Key information

Conditions

Hip Arthroplasty General Anesthesia Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Caen University Hospital

Caen, 14 000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plethysmographic variability index

Device

Primary outcomes

  1. 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

  1. Troponin value

    Time frame: Postoperative Day 1 and Day 3

  2. Creatinine value

    Time frame: Postoperative Day 1 and Day 3

  3. Arterial Lactate

    Time frame: 1 hour after end of surgery

  4. Postoperative cardiac complications

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

  5. Theorical length of hospital stay after knee or hip arthroplasty

    Time frame: 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

Other outcomes

  1. Medico economic evaluation

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

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: OPVI

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 4, 2014
Registry last updated
May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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