Arthroplasty, Replacement, HipNCT04996420
Goal Directed Fluid Therapy Versus Liberal Fluid Regimen in Primary Elective Hip Artrhoplasty
A study testing Clearsight non invasive hemodynamic monitoring in people with Arthroplasty, Replacement, Hip and Anesthesia, Spinal, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Patients undergoing elective primary total hip replacement and spinal anesthesia may encounter significant hemodynamic instability. The study is a randomized controlled type and is aimed at comparing how perioperatory hypotension and fluid regimen are managed using Clearsight non invasive monitoring system or PAM… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Arthroplasty, Replacement, Hip, Anesthesia, Spinal, Hemodynamic Monitoring
- What is being tested?
- Clearsight non invasive hemodynamic monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 22 May 2019to 22 Nov 2020
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50-80 years
- ASA I, II or III
- primary elective hip arthroplasty
Who cannot join
- spinal anesthesia contraindications
- periferical vasculopaty
- other diseases which indicates better an invasive monitoring by radial artery cannulation
- atrial fibrillation
- denial or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Goal Directed Fluid Management vs Liberal Fluid Regimen Based on Mean Arterial Pressure in Patients Undergoing Spinal Anesthesia for Primary Elective Hip Arthroplasty: a Randomized, Prospective, Controlled Study."
Patients undergoing elective primary total hip replacement and spinal anesthesia may encounter significant hemodynamic instability.
The study is a randomized controlled type and is aimed at comparing how perioperatory hypotension and fluid regimen are managed using Clearsight non invasive monitoring system or PAM monitoring.
Read more
The primary endpoint is to evaluate total duration of hypotension, defined as a MAP < 65 mmHg, calculated during all the perioperatory time.
Fifty-eight patients, aged 50-80 years, with an American Society of Anaesthesiologists' (ASA) score I, II and III were enrolled and split in two groups (Clearsight and control group). Patients were monitored both with the EV1000 platform, the Clearsight finger-cuff and MAP monitoring. Depending on the group, the fluid regimen was a goal directed fluid therapy or a liberal fluid regimen.
- Conditions
- Arthroplasty, Replacement, Hip, Anesthesia, Spinal, Hemodynamic Monitoring, Crystalloid Solutions
- Being tested
- Clearsight non invasive hemodynamic monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clearsight non invasive hemodynamic monitoringDevice
Goal directed fluid therapy fuided by Clearsight monitoring
| Study group | Role | What they receive |
|---|---|---|
| Clearsight | Experimental | hemodynamic monitoring and goal directed fluid therapy guided by clearsight Receives: Device: Clearsight non invasive hemodynamic monitoring |
| Control | Other | hemodynamic monitoring blinded and silenced, no goal directed fluid therapy. Fluid therapy based on clinical evaluation and mean arterial pressure by non-invasive monitoring Receives: Device: Clearsight non invasive hemodynamic monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
total perioperative hypotension time defined by a mean arterial pressure < 65mmHg, from arrival in the anesthesia induction room to resolution of spinal block in Recovery Room (i.e. up to 8 hours)
Measured: from arrival in the anesthesia induction room to resolution of spinal block in Recovery Room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start22 May 2019
- Primary completion22 Nov 2020
- Study completion22 Nov 2020
Why it stopped: change in surgical technique (lateral approach vs anterior approach for hip arthroplasty, determining a change in patient intraoperative positioning)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Bonarelli, MD, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996420
- Sponsor's protocol ID
- Emospin 2
- Status last verified
- Jul 2021
- First submitted
- 29 Jan 2020
- Last updated
- 1 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal Directed Fluid Management vs Liberal Fluid Regimen Based on Mean Arterial Pressure in Patients Undergoing Spinal Anesthesia for Primary Elective Hip Arthroplasty: a Randomized, Prospective, Controlled Study."
- ClinicalTrials.gov ID
- NCT04996420
- Acronym / sponsor ID
- Emospin 2
- Conditions
- Arthroplasty, Replacement, Hip, Anesthesia, Spinal, Hemodynamic Monitoring, Crystalloid Solutions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: change in surgical technique (lateral approach vs anterior approach for hip arthroplasty, determining a change in patient intraoperative positioning)
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 22 May 2019 (actual)
- Primary completion
- 22 Nov 2020 (actual)
- Study completion
- 22 Nov 2020 (actual)
- First posted
- 9 Aug 2021 (actual)
- 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.
Patients undergoing elective primary total hip replacement and spinal anesthesia may encounter significant hemodynamic instability.
The study is a randomized controlled type and is aimed at comparing how perioperatory hypotension and fluid regimen are managed using Clearsight non invasive monitoring system or PAM monitoring.
The primary endpoint is to evaluate total duration of hypotension, defined as a MAP < 65 mmHg, calculated during all the perioperatory time.
Fifty-eight patients, aged 50-80 years, with an American Society of Anaesthesiologists' (ASA) score I, II and III were enrolled and split in two groups (Clearsight and control group). Patients were monitored both with the EV1000 platform, the Clearsight finger-cuff and MAP monitoring. Depending on the group, the fluid regimen was a goal directed fluid therapy or a liberal fluid regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clearsight | Experimental | Device: Clearsight non invasive hemodynamic monitoringhemodynamic monitoring and goal directed fluid therapy guided by clearsight |
| Control | Other | Device: Clearsight non invasive hemodynamic monitoringhemodynamic monitoring blinded and silenced, no goal directed fluid therapy. Fluid therapy based on clinical evaluation and mean arterial pressure by non-invasive monitoring |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50-80 years
- ASA I, II or III
- primary elective hip arthroplasty
Key exclusion criteria (5 listed)
- spinal anesthesia contraindications
- periferical vasculopaty
- other diseases which indicates better an invasive monitoring by radial artery cannulation
- atrial fibrillation
- denial or inability to provide informed consent
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 |
|---|---|---|
| Clearsight non invasive hemodynamic monitoringGoal directed fluid therapy fuided by Clearsight monitoring | Device | Clearsight, Control |
Primary outcome
total perioperative hypotension time defined by a mean arterial pressure < 65mmHg, from arrival in the anesthesia induction room to resolution of spinal block in Recovery Room (i.e. up to 8 hours)
Time frame: from arrival in the anesthesia induction room to resolution of spinal block in Recovery Room
Results and safety
The study was stopped early (reason given: change in surgical technique (lateral approach vs anterior approach for hip arthroplasty, determining a change in patient intraoperative positioning)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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.
Stefano Bonarelli, MD principal investigator
Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clearsight non invasive hemodynamic monitoring in people with Arthroplasty, Replacement, Hip and Anesthesia, Spinal, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 1 Jun 2023. 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 Italy. 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.
Are results available for this study?
The study was stopped early (reason given: change in surgical technique (lateral approach vs anterior approach for hip arthroplasty, determining a change in patient intraoperative positioning)). Results are not available in the source record.
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?
total perioperative hypotension time defined by a mean arterial pressure < 65mmHg, from arrival in the anesthesia induction room to resolution of spinal block in Recovery Room (i.e. up to 8 hours) (time frame: from arrival in the anesthesia induction room to resolution of spinal block in Recovery Room). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2023; AzTrials last refreshed its copy on 6 Nov 2026.