Fluid ResponsivenessNCT04002193
Pleth Variability Index in Modified Prone Position or Knee-chest Position (Concord Position)
An observational study of Fluid Responsiveness and Modified Prone Position, run by Asan Medical Center at 1 site in South Korea.
Trial summary
To investigate whether PVI predicts the fluid responsiveness in modified prone position undergoing posterior approach cervical operation. Furthermore, modified prone position could influence on dynamic variables including stroke volume variation(SVV), pulse pressure variation(PPV) and PVI. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Fluid Responsiveness, Modified Prone Position
- What is being tested?
- volume expansion
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Dec 2019to 31 Oct 2020
- 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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients received cervical operation at modified prone position (concord position)
Who may be able to join
- American Society of Anaesthesiologists'(ASA) physical status 1-3
- patients who received cervical operation in modified prone position or knee-chest position
Who cannot join
- Valvular heart disease
- Congestive heart failure, reduced left ventricular function ( Ejection fraction < 40%)
- Moderate grade of pulmonary disease
- Arrhythmia (atrial fibrillation, atrial flutter.. etc.)
- body mass index > 30 or < 15 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pleth Variability Index as Predictors of Fluid Responsiveness in Modified Prone Position(Concord Position) or Knee-chest Position
To investigate whether PVI predicts the fluid responsiveness in modified prone position undergoing posterior approach cervical operation. Furthermore, modified prone position could influence on dynamic variables including stroke volume variation(SVV), pulse pressure variation(PPV) and PVI.
Read the detailed description
Objective :
To compare measurements of pleth variability index (PVI), pulse pressure variation (PPV) and stroke volume variation (SVV) to predict fluid responsiveness in modified prone position or knee-chest position (concord position) for cervical operation.
To identify Influence of the modified prone position (concord position) on these variables.
Method
- To assess influence of the position change on PVI and other variables(PPV, SVV)
- To assess PVI to predict fluid responsiveness at modified prone position
- Conditions
- Fluid Responsiveness, Modified Prone Position
- Being tested
- volume expansion
- Keywords
- Pleth variability index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
volume expansionOther
Also called If stroke volume of FloTrac® decrease 15 % of baseline, crystalloid loading of 4ml/kg will start.
To assess fluid responsiveness
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess influence of the position change on PVI and other variables(PPV, SVV)
When position change from supine to modified prone position, to assess the change of PVI and other variables. The correlation of PVI and cardiac output during this change.
Measured: 1.supine position : 5 minute after anesthesia induction with arterial-line insertion 2. 5 min after crystalloid 4 ml/kg loading / 3. modified prone position (baseline)
Secondary outcomes (1)
To measure dynamic variables (pulse pressure variation, stroke volume variation and pleth variability index) in modified prone position
Record the data of variables after 5 minute hemodynamic stability without changes of drugs
Measured: 1. Supine position : 5 minute after anesthesia induction with arterial-line insertion 2. 5 minute after a position change to prone 3. before and after fluid loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start6 Dec 2019
- Primary completion26 Oct 2020
- Study completion31 Oct 2020
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.
- 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heesun Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002193
- Sponsor's protocol ID
- HePark
- Status last verified
- Mar 2022
- First submitted
- 24 May 2019
- Last updated
- 24 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We did not have the permission of data share from institutional review board.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pleth Variability Index as Predictors of Fluid Responsiveness in Modified Prone Position(Concord Position) or Knee-chest Position
- ClinicalTrials.gov ID
- NCT04002193
- Acronym / sponsor ID
- HePark
- Conditions
- Fluid Responsiveness, Modified Prone Position
- Keywords
- Pleth variability index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 26 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 28 Jun 2019 (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.
To investigate whether PVI predicts the fluid responsiveness in modified prone position undergoing posterior approach cervical operation. Furthermore, modified prone position could influence on dynamic variables including stroke volume variation(SVV), pulse pressure variation(PPV) and PVI.
Detailed description
Objective :
To compare measurements of pleth variability index (PVI), pulse pressure variation (PPV) and stroke volume variation (SVV) to predict fluid responsiveness in modified prone position or knee-chest position (concord position) for cervical operation.
To identify Influence of the modified prone position (concord position) on these variables.
Method
- To assess influence of the position change on PVI and other variables(PPV, SVV)
- To assess PVI to predict fluid responsiveness at modified prone position
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients received cervical operation at modified prone position (concord position)
Key inclusion criteria (2 listed)
- American Society of Anaesthesiologists'(ASA) physical status 1-3
- patients who received cervical operation in modified prone position or knee-chest position
Key exclusion criteria (5 listed)
- Valvular heart disease
- Congestive heart failure, reduced left ventricular function ( Ejection fraction < 40%)
- Moderate grade of pulmonary disease
- Arrhythmia (atrial fibrillation, atrial flutter.. etc.)
- body mass index > 30 or < 15 kg/m2
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 |
|---|---|---|
| volume expansionAlso: If stroke volume of FloTrac® decrease 15 % of baseline, crystalloid loading of 4ml/kg will start.To assess fluid responsiveness | Other | – |
Primary outcome
To assess influence of the position change on PVI and other variables(PPV, SVV)
Time frame: 1.supine position : 5 minute after anesthesia induction with arterial-line insertion 2. 5 min after crystalloid 4 ml/kg loading / 3. modified prone position (baseline)
When position change from supine to modified prone position, to assess the change of PVI and other variables. The correlation of PVI and cardiac output during this change.
1 secondary outcome
To measure dynamic variables (pulse pressure variation, stroke volume variation and pleth variability index) in modified prone position
Time frame: 1. Supine position : 5 minute after anesthesia induction with arterial-line insertion 2. 5 minute after a position change to prone 3. before and after fluid loading
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 24 Mar 2022.
- Individual participant dataSharing planned: Undecided. We did not have the permission of data share from institutional review board.
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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?
An observational study of Fluid Responsiveness and Modified Prone Position, run by Asan 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 2 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: finished, as of the sponsor's last update on 24 Mar 2022. 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?
To assess influence of the position change on PVI and other variables(PPV, SVV) (time frame: 1.supine position : 5 minute after anesthesia induction with arterial-line insertion 2. 5 min after crystalloid 4 ml/kg loading / 3. modified prone position (baseline)). 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 24 Mar 2022.