OPVI: Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery

• Sponsor: University Hospital, Caen (Other)
• Overall Status: Completed
• CT.gov ID: NCT02207296
• Collaborator: (none)
• Enrollment: 440
• Location: 1
• Arms: 2
• Actual Duration (Months): 33
• Patients Per Site Per Month: 13.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Arthroplasty; Knee Arthroplasty; General Anesthesia	Device: Plethysmographic variability index	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 440 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery : a Multicentric Prospective Randomized Controlled Study
• Actual Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Feb 1, 2017
• Actual Study Completion Date: Nov 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: PVI group Fluid optimisation using PVI	Device: Plethysmographic variability index
No Intervention: Control group Standard care using a hemodynamic protocol during general anesthesia

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Troponin value [Postoperative Day 1 and Day 3]

2. Creatinine value [Postoperative Day 1 and Day 3]

3. Arterial Lactate [1 hour after end of surgery]

4. Postoperative cardiac complications [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 [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 Outcome Measures

1. Medico economic evaluation [Participants will be followed for the duration of hospital stay, an expected average of 1 week, until postoperative day 60]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Caen University Hospital	Caen		France	14 000

Sponsors and Collaborators

• University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Caen
• ClinicalTrials.gov Identifier: NCT02207296
• Other Study ID Numbers: 2014-A00330-47
• First Posted: Aug 4, 2014
• Last Update Posted: May 15, 2019
• Last Verified: May 1, 2019

Study Results

No Results Posted as of May 15, 2019