Neurological Diseases or ConditionsNCT01898975
A Gray Zone Approach to Stroke Volume Variation Derived From NICOM
An observational study of Neurological Diseases or Conditions and Fluid Responsiveness, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Optimal fluid management has been considered as crucial part to determine postoperative outcome and organ function. Recently developed, non invasive cardiac output measurement(NICOM, Cheetah Medical, Portland, OR)has enabled continuous cardiac output(CO) monitoring just by attaching electrode on chest wall. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Neurological Diseases or Conditions, Fluid Responsiveness, Non Invasive Cardiac Output Monitoring
- What is being tested?
- 500ml fluid loading
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to May 2014
- 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 neurosurgery under general anesthesia in supine position
Who may be able to join
- ASA I or ASA II patients aged 20-80 undergoing neurosurgery in supine position
Who cannot join
- Pre-existing arrythmic disorders
- Congestive heart failure required medical treatment
- Preoperative Creatinine 1.3mg/dl
- observing self respiration during the study interventions
- Bleeding tendency
- Severe brain edema
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Stroke Volume Variation Derived From NICOM as a Predictor of Fluid Responsiveness in Neurosurgical Patients: A Gray Zone Approach
Optimal fluid management has been considered as crucial part to determine postoperative outcome and organ function. Recently developed, non invasive cardiac output measurement(NICOM, Cheetah Medical, Portland, OR)has enabled continuous cardiac output(CO) monitoring just by attaching electrode on chest wall. Moreover, CO and SSV derived from NICOM have been demonstrated as predictors of fluid responsiveness. Therefore, the aim of this study is to evaluate stroke volume variation derived from NICOM as a predictor of fluid responsiveness in neurosurgical patients. In addition, we plan to reveal inconclusive patients using gray zone approach.
Read the detailed description
Optimal fluid management has been considered as crucial part to determine postoperative outcome and organ function. Many reports have focussed on evaluation of fluid responsiveness using various parameters such as pulse pressure variation (PPV) or stroke volume variation (SSV) derived from invasive or semi-invasive monitoring. Recently developed, non invasive cardiac output measurement(NICOM, Cheetah Medical, Portland, OR)has enabled continuous cardiac output(CO) monitoring just by attaching electrode on thorax. Moreover, CO and SSV derived from NICOM have been demonstrated as predictors of fluid responsiveness. Therefore, the aim of this study is to evaluate stroke volume variation derived from NICOM as a predictor of fluid responsiveness in neurosurgical patients. In addition, we plan to reveal inconclusive patients using gray zone approach.
- Conditions
- Neurological Diseases or Conditions, Fluid Responsiveness, Non Invasive Cardiac Output Monitoring, Gray Zone
- Being tested
- 500ml fluid loading
- Keywords
- Neurosurgical patients, Fluid loading, Fluid responsiveness, NICOM, Stroke volume variation, Pulse pressure variation, Total peripheral resistance, Gray zone approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
500ml fluid loadingOther
Also called 500ml loading of crystalloid(Plasma Solution-A Injection CJ) over 15min, at the end of operation, when the main procedure finished and there is no strong, stimulation with stable hemodynamics
Fluid loading to evaluate fluid responsiveness
| Study group | Role | What they receive |
|---|---|---|
| 500ml fluid loading | All enrolled patients Receives: Other: 500ml fluid loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke volume variation
5min following the end of rapid fluid infusion: 5 min after the end of fluid loading
Measured: 5min following the end of rapid fluid infusion
Secondary outcomes (1)
Correlation with pulse pressure variation
5min following the end of rapid fluid infusion: 5 min after the end of fluid loading
Measured: 5 min following the end of rapid fluid infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2014 (estimated)
- Study completionMay 2014 (estimated)
Why it stopped: The investigators decided not to proceed this study because of some internal matters.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological Diseases or ConditionsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 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
- Jong-Hwan Lee, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898975
- Sponsor's protocol ID
- 2013-03-053-001
- Status last verified
- May 2016
- First submitted
- 28 Jun 2013
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. 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 Neurosurgical Patients: A Gray Zone Approach
- ClinicalTrials.gov ID
- NCT01898975
- Acronym / sponsor ID
- 2013-03-053-001
- Conditions
- Neurological Diseases or Conditions, Fluid Responsiveness, Non Invasive Cardiac Output Monitoring, Gray Zone
- Keywords
- Neurosurgical patients, Fluid loading, Fluid responsiveness, NICOM, Stroke volume variation, Pulse pressure variation, Total peripheral resistance, Gray zone approach
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The investigators decided not to proceed this study because of some internal matters.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 15 Jul 2013 (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.
Optimal fluid management has been considered as crucial part to determine postoperative outcome and organ function. Recently developed, non invasive cardiac output measurement(NICOM, Cheetah Medical, Portland, OR)has enabled continuous cardiac output(CO) monitoring just by attaching electrode on chest wall. Moreover, CO and SSV derived from NICOM have been demonstrated as predictors of fluid responsiveness. Therefore, the aim of this study is to evaluate stroke volume variation derived from NICOM as a predictor of fluid responsiveness in neurosurgical patients. In addition, we plan to reveal inconclusive patients using gray zone approach.
Detailed description
Optimal fluid management has been considered as crucial part to determine postoperative outcome and organ function. Many reports have focussed on evaluation of fluid responsiveness using various parameters such as pulse pressure variation (PPV) or stroke volume variation (SSV) derived from invasive or semi-invasive monitoring. Recently developed, non invasive cardiac output measurement(NICOM, Cheetah Medical, Portland, OR)has enabled continuous cardiac output(CO) monitoring just by attaching electrode on thorax. Moreover, CO and SSV derived from NICOM have been demonstrated as predictors of fluid responsiveness. Therefore, the aim of this study is to evaluate stroke volume variation derived from NICOM as a predictor of fluid responsiveness in neurosurgical patients. In addition, we plan to reveal inconclusive patients using gray zone approach.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 500ml fluid loading | – | Other: 500ml fluid loadingAll enrolled patients |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing neurosurgery under general anesthesia in supine position
Key inclusion criteria (1 listed)
- ASA I or ASA II patients aged 20-80 undergoing neurosurgery in supine position
Key exclusion criteria (6 listed)
- Pre-existing arrythmic disorders
- Congestive heart failure required medical treatment
- Preoperative Creatinine 1.3mg/dl
- observing self respiration during the study interventions
- Bleeding tendency
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 |
|---|---|---|
| 500ml fluid loadingAlso: 500ml loading of crystalloid(Plasma Solution-A Injection CJ) over 15min, at the end of operation, when the main procedure finished and there is no strong, stimulation with stable hemodynamicsFluid loading to evaluate fluid responsiveness | Other | 500ml fluid loading |
Primary outcome
Stroke volume variation
Time frame: 5min following the end of rapid fluid infusion
5min following the end of rapid fluid infusion: 5 min after the end of fluid loading
1 secondary outcome
Correlation with pulse pressure variation
Time frame: 5 min following the end of rapid fluid infusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
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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.
Jong-Hwan Lee, MD, PhD principal investigator
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 Neurological Diseases or Conditions and Fluid Responsiveness, 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 6 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: withdrawn, as of the sponsor's last update on 27 May 2016. 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 was withdrawn before enrolling participants, so there are no results.
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 (time frame: 5min following the end of rapid fluid infusion). 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 27 May 2016; AzTrials last refreshed its copy on 29 Oct 2026.