Fluid ResponsivenessNCT02277353
Evaluation of SVV From NICOM as a Predictor of Fluid Responsiveness in Prone Position During Spine Surgery
An observational study of Fluid Responsiveness and Prone Position, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
NICOM® is a recently developed noninvasive cardiac output monitoring device, and indices derived from NICOM® such as SVV has been reported to predict fluid responsiveness in the previous studies. However, its usefulness in prone positioning has not been investigated. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Fluid Responsiveness, Prone Position, Non Invasive Cardiac Output Monitoring
- What is being tested?
- Fluid loading to evaluate fluid responsiveness
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to Jun 2015
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing spine surgery under general anesthesia in prone position
Who may be able to join
- ASA I or II patients undergoing spine surgery in prone position
Who cannot join
- Pre-existing arrhythmic disorders/moderate to severe valvular heart disease/obstructive pulmonary disease (COPD grade >2), left ventricular dysfunction with LV EF less than 50, preoperative need for inotropics or vasopressors
- BMI >30kg/m^2 or <15kg/m^2
- Preoperative serum Cr > 1.3mg/dL
- Patients with coagulopathy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Seoul Hospital, Samsung Medical Center
Seoul, 135-710
About this study
Official title: Evaluation of Stroke Volume Variation Derived From NICOM as a Predictor of Fluid Responsiveness in Prone Position During Spine Surgery
NICOM® is a recently developed noninvasive cardiac output monitoring device, and indices derived from NICOM® such as SVV has been reported to predict fluid responsiveness in the previous studies. However, its usefulness in prone positioning has not been investigated. Thus, the aim of this prospective observational study is to evaluate the usefulness of stroke volume variation (SVV) derived from NICOM® to predict fluid responsiveness in prone patients undergoing spine surgery.
- Being tested
- Fluid loading to evaluate fluid responsiveness
- Keywords
- Fluid responsiveness, NICOM, Prone Position, Stroke Volume Variation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid loading to evaluate fluid responsivenessOther
loading of hydroxyethyl starch 6ml/kg over 10-15min to all patients
| Study group | Role | What they receive |
|---|---|---|
| All enrolled patients | This study enrolls patients undergoing elective spine surgery in prone position and all enrolled subjects may receive fluid loading with hemodynamic monitoring by Flotrac/Vigileo and NICOM, but the investigator does not assign specific interventions to the subjects of the study because this is a prospective observational study. Receives: Other: Fluid loading to evaluate fluid responsiveness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke volume variation from NICOM®
predictability of stroke volume variation from NICOM® for fluid responsiveness
Measured: 5 min after infusion of bolus fluid
Secondary outcomes (1)
pulse pressure variation and stroke volume variation from Flotrac/Vigileo system
Correlation with pulse pressure variation, stroke volume variation from Flotrac/Vigileo system
Measured: 5 min after infusion of bolus fluid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid ResponsivenessStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Hwan Lee, Samsung Medical Center
- Investigators
- Jeong Jin Min, MD, Study director, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277353
- Sponsor's protocol ID
- 2014-05-090-003
- Status last verified
- Jul 2015
- First submitted
- 9 Oct 2014
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Stroke Volume Variation Derived From NICOM as a Predictor of Fluid Responsiveness in Prone Position During Spine Surgery
- ClinicalTrials.gov ID
- NCT02277353
- Acronym / sponsor ID
- 2014-05-090-003
- Keywords
- Fluid responsiveness, NICOM, Prone Position, Stroke Volume Variation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 29 Oct 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.
NICOM® is a recently developed noninvasive cardiac output monitoring device, and indices derived from NICOM® such as SVV has been reported to predict fluid responsiveness in the previous studies. However, its usefulness in prone positioning has not been investigated. Thus, the aim of this prospective observational study is to evaluate the usefulness of stroke volume variation (SVV) derived from NICOM® to predict fluid responsiveness in prone patients undergoing spine surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All enrolled patients | – | Other: Fluid loading to evaluate fluid responsivenessThis study enrolls patients undergoing elective spine surgery in prone position and all enrolled subjects may receive fluid loading with hemodynamic monitoring by Flotrac/Vigileo and NICOM, but the investigator does not assign specific interventions to the subjects of the study because this is a prospective observational study. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing spine surgery under general anesthesia in prone position
Key inclusion criteria (1 listed)
- ASA I or II patients undergoing spine surgery in prone position
Key exclusion criteria (4 listed)
- Pre-existing arrhythmic disorders/moderate to severe valvular heart disease/obstructive pulmonary disease (COPD grade >2), left ventricular dysfunction with LV EF less than 50, preoperative need for inotropics or vasopressors
- BMI >30kg/m^2 or <15kg/m^2
- Preoperative serum Cr > 1.3mg/dL
- Patients with coagulopathy
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 |
|---|---|---|
| Fluid loading to evaluate fluid responsivenessloading of hydroxyethyl starch 6ml/kg over 10-15min to all patients | Other | All enrolled patients |
Primary outcome
Stroke volume variation from NICOM®
Time frame: 5 min after infusion of bolus fluid
predictability of stroke volume variation from NICOM® for fluid responsiveness
1 secondary outcome
pulse pressure variation and stroke volume variation from Flotrac/Vigileo system
Time frame: 5 min after infusion of bolus fluid
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 21 Jul 2015.
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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.
Jeong Jin Min, MD study director
Samsung Medical Center
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 Fluid Responsiveness and Prone Position, run by Samsung Medical Center at 1 site in South Korea.
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 1 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 21 Jul 2015. 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 South Korea. 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 variation from NICOM® (time frame: 5 min after infusion of bolus fluid). 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 21 Jul 2015.