Hip ArthroplastyPhase 3OPVINCT02207296
Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery
A Phase 3 study testing Plethysmographic variability index in people with Hip Arthroplasty and Knee Arthroplasty, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthroplasty, Knee Arthroplasty, General Anesthesia
- What is being tested?
- Plethysmographic variability index
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Nov 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Indication to a knee or hip arthroplasty under general anesthesia
- Sinusal rhythm
- Non Inclusion Criteria:
- Pregnant women
- Black skin
Show all 10Show fewer
- Dialysis
- Cardiac arrythmia
- Sepsis
- Use of another hemodynamic monitoring during surgery
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery : a Multicentric Prospective Randomized Controlled Study
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.
- Conditions
- Hip Arthroplasty, Knee Arthroplasty, General Anesthesia
- Being tested
- Plethysmographic variability index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plethysmographic variability indexDevice
| Study group | Role | What they receive |
|---|---|---|
| PVI group | Other | Fluid optimisation using PVI Receives: Device: Plethysmographic variability index |
| Control group | No intervention | Standard care using a hemodynamic protocol during general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Real length of hospital stay expressed as number of day (maximum 60 days)
Secondary outcomes (5)
Troponin value
Measured: Postoperative Day 1 and Day 3
Creatinine value
Measured: Postoperative Day 1 and Day 3
Arterial Lactate
Measured: 1 hour after end of surgery
Postoperative cardiac complications
Measured: 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
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
Measured: Theorical length of hospital stay expressed as number of day (maximum 60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207296
- Sponsor's protocol ID
- 2014-A00330-47
- Acronym
- OPVI
- Status last verified
- May 2019
- First submitted
- 17 Jun 2014
- Last updated
- 15 May 2019
- Results posted
- No
Publications
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.
PubMed 26537815
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery : a Multicentric Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02207296
- Acronym / sponsor ID
- OPVI / 2014-A00330-47
- Conditions
- Hip Arthroplasty, Knee Arthroplasty, General Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 4 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI group | Other | Device: Plethysmographic variability indexFluid optimisation using PVI |
| Control group | No intervention | –Standard care using a hemodynamic protocol during general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age > 18 years
- Indication to a knee or hip arthroplasty under general anesthesia
- Sinusal rhythm
- Pregnant women
- Black skin
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plethysmographic variability index | Device | PVI group |
Primary outcome
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.
5 secondary outcomes
Troponin value
Time frame: Postoperative Day 1 and Day 3
Creatinine value
Time frame: Postoperative Day 1 and Day 3
Arterial Lactate
Time frame: 1 hour after end of surgery
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Derived from this study: PubMed 26537815Fischer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Plethysmographic variability index in people with Hip Arthroplasty and Knee Arthroplasty, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay after knee or hip arthroplasty (time frame: Real length of hospital stay expressed as number of day (maximum 60 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02207296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.