HemodynamicsNCT03086603
Observation of Principal Hemodynamic Variables After Spinal Anesthesia With Non Invasive Hemodynamic Monitoring
An observational study of Hemodynamics and Fluid Therapy, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The study is aimed at observe how spinal anesthesia modifies the hemodynamic state of the patient after optimization to preload independence with a Goal Directed Therapy algorithm guided by non invasive hemodynamic monitoring with Clearsight. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Hemodynamics, Fluid Therapy, Anesthesia, Spinal
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2016to May 2016
- Phase
- Observational
- 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
Study population: Thirty patients aged between 50 and 80 years, with an American Society of Anaesthesiologists' (ASA) score 2 or 3 and scheduled for elective primary total hip arthroplasty under spinal anaesthesia. Exclusion criteria were contraindications to neuraxial anaesthesia, peripheral vascular abnormalities (severe vascular diseases, Raynaud's disease, arteriovenous fistula for hemodialysis, previous vascular surgery of the upper arms, advanced diabetes with neuropathy or vascular disease), ASA classes 1, 4 and 5 and patients' refusal.
Who may be able to join
- scheduled for elective primary hip arthroplasty
- scheduled for spinal anesthesia
- American Society of Anaesthesiologists' (ASA) score 2 or 3
- aged between 50 and 80 years
Who cannot join
- contraindications to neuraxial anaesthesia
- peripheral vascular abnormalities
- American Society of Anaesthesiologists' (ASA) score 1, 4 and 5
- patients' refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Study About Variation of Principal Hemodynamic Parameters, Collected With Non-invasive Monitoring, in Patients Undergoing Spinal Anesthesia for Primary Elective Hip Arthroplasty.
The study is aimed at observe how spinal anesthesia modifies the hemodynamic state of the patient after optimization to preload independence with a Goal Directed Therapy algorithm guided by non invasive hemodynamic monitoring with Clearsight.
Read the detailed description
This is an observational prospective single group study.
Patients will be monitored with ECG (III leads), non invasive blood pressure cuff (NIBP) cuff, pulse oximetry and Clearsight finger cuff after their arrival in the operating room. Basal Stroke Volume (SV) and indexed Stroke Volume (SVI) will be registered.
The basal value will be optimized according to the study goal directed fluid therapy algorithm: a 200ml fluid challenge will be administered until the SV will increase of at least 10%. When the SV will stop increasing significantly after crystalloid administration, the SV and SVI value will be registered as SVoptimized (SVopt) and SVI optimized (SVIopt), while the same values trigger of the last fluid challenge will be registered as SVtarget1 and SVItarget1. A constant infusion of crystalloids 2 ml/Kg/h will be maintained throughout the study period.
Then, spinal anesthesia will be administered (levobupivacaine 0.5% 0.25mg/kg of ideal weight) in lateral decubitus. After 15 minutes, patients will be turned supine and after 5 minutes SV and SVI will be registered and compared with values SVtarget1 and SVItarget1: if within 10% of range, data will be registered as SVtarget2 and SVItarget2 and patient will maintain basal crystalloid infusion. Otherwise, patients will receive a fluid optimization similar to what described previously before spinal, until values will be within 10% of range of SV and SVI.
Afterwards patients will be transferred to the operating room and will be followed as described in Figure 2. At the end of surgery, patients will be transferred to the Recovery Room and will be monitored and optimized.
When patients will reach an Aldrete's Score ≥ 9/10 and a Bromage's score = 0 with sensibility restored at S1, we will compare SV and SVI value with SVtarget1 and SVItarget1 and treated accordingly.
Spontaneous micturition will be tested and in case a bladder volume > 600ml will be detected with ultrasound before recovery room discharge criteria fulfillment, we will proceed with urinary catheterization.
At patient discharge from the Recovery Room the study will be completed.
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke volume and stroke volume index
stroke volume and stroke volume index variation after spinal anesthesia
Measured: duration of spinal anesthesia procedure
Secondary outcomes (3)
cardiac output and cardiac index
cardiac output and cardiac index variation after spinal anesthesia
Measured: duration of spinal anesthesia procedure
peripheral vascular resistance index (SVRI)
peripheral vascular resistance index variation after spinal anesthesia
Measured: duration of spinal anesthesia procedure
episodes of hypotension and hypertension intraoperatively
variation of Mean Arterial Pressure (MAP) +/- 30% os basal value
Measured: duration of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study startMar 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodynamicsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Ghisi, Istituto Ortopedico Rizzoli
- Investigators
- Stefano Bonarelli, MD, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086603
- Sponsor's protocol ID
- EmoSpin
- Status last verified
- Mar 2017
- First submitted
- 28 Feb 2017
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study About Variation of Principal Hemodynamic Parameters, Collected With Non-invasive Monitoring, in Patients Undergoing Spinal Anesthesia for Primary Elective Hip Arthroplasty.
- ClinicalTrials.gov ID
- NCT03086603
- Acronym / sponsor ID
- EmoSpin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 22 Mar 2017 (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.
The study is aimed at observe how spinal anesthesia modifies the hemodynamic state of the patient after optimization to preload independence with a Goal Directed Therapy algorithm guided by non invasive hemodynamic monitoring with Clearsight.
Detailed description
This is an observational prospective single group study.
Patients will be monitored with ECG (III leads), non invasive blood pressure cuff (NIBP) cuff, pulse oximetry and Clearsight finger cuff after their arrival in the operating room. Basal Stroke Volume (SV) and indexed Stroke Volume (SVI) will be registered.
The basal value will be optimized according to the study goal directed fluid therapy algorithm: a 200ml fluid challenge will be administered until the SV will increase of at least 10%. When the SV will stop increasing significantly after crystalloid administration, the SV and SVI value will be registered as SVoptimized (SVopt) and SVI optimized (SVIopt), while the same values trigger of the last fluid challenge will be registered as SVtarget1 and SVItarget1. A constant infusion of crystalloids 2 ml/Kg/h will be maintained throughout the study period.
Then, spinal anesthesia will be administered (levobupivacaine 0.5% 0.25mg/kg of ideal weight) in lateral decubitus. After 15 minutes, patients will be turned supine and after 5 minutes SV and SVI will be registered and compared with values SVtarget1 and SVItarget1: if within 10% of range, data will be registered as SVtarget2 and SVItarget2 and patient will maintain basal crystalloid infusion. Otherwise, patients will receive a fluid optimization similar to what described previously before spinal, until values will be within 10% of range of SV and SVI.
Afterwards patients will be transferred to the operating room and will be followed as described in Figure 2. At the end of surgery, patients will be transferred to the Recovery Room and will be monitored and optimized.
When patients will reach an Aldrete's Score ≥ 9/10 and a Bromage's score = 0 with sensibility restored at S1, we will compare SV and SVI value with SVtarget1 and SVItarget1 and treated accordingly.
Spontaneous micturition will be tested and in case a bladder volume > 600ml will be detected with ultrasound before recovery room discharge criteria fulfillment, we will proceed with urinary catheterization.
At patient discharge from the Recovery Room the study will be completed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thirty patients aged between 50 and 80 years, with an American Society of Anaesthesiologists' (ASA) score 2 or 3 and scheduled for elective primary total hip arthroplasty under spinal anaesthesia. Exclusion criteria were contraindications to neuraxial anaesthesia, peripheral vascular abnormalities (severe vascular diseases, Raynaud's disease, arteriovenous fistula for hemodialysis, previous vascular surgery of the upper arms, advanced diabetes with neuropathy or vascular disease), ASA classes 1, 4 and 5 and patients' refusal.
Key inclusion criteria (4 listed)
- scheduled for elective primary hip arthroplasty
- scheduled for spinal anesthesia
- American Society of Anaesthesiologists' (ASA) score 2 or 3
- aged between 50 and 80 years
Key exclusion criteria (4 listed)
- contraindications to neuraxial anaesthesia
- peripheral vascular abnormalities
- American Society of Anaesthesiologists' (ASA) score 1, 4 and 5
- patients' refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
stroke volume and stroke volume index
Time frame: duration of spinal anesthesia procedure
stroke volume and stroke volume index variation after spinal anesthesia
3 secondary outcomes
cardiac output and cardiac index
Time frame: duration of spinal anesthesia procedure
peripheral vascular resistance index (SVRI)
Time frame: duration of spinal anesthesia procedure
episodes of hypotension and hypertension intraoperatively
Time frame: duration of surgery
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 22 Mar 2017.
- Individual participant dataSharing planned: No
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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?
An observational study of Hemodynamics and Fluid Therapy, 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 4 inclusion and 4 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 22 Mar 2017. 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 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?
stroke volume and stroke volume index (time frame: duration of spinal anesthesia procedure). 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 22 Mar 2017.