Intravascular VolumeNCT03673475
Internal Jugular Vein Distensibility and Pleth Variability Index(PVI) for Evaluating Fluid Responsiveness
An observational study of Intravascular Volume, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Assessment of intravascular volume status is crucial in order to predict the efficacy of volume status in major abdominal surgery. The aim of the study is to verify the feasibility and usefulness of the internal jugular vein distensibility index as an adjunct to the pleth variebility index(PVI) to predict fluid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intravascular Volume
- What is being tested?
- Assessment of fluid responsiveness
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2018to 30 Sep 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing major abdominal surgery
Who may be able to join
- American Society of Anesthesiologists(ASA) physical status I-III patients
- patients undergoing major abdominal surgery
Who cannot join
- arrythmia
- severe right ventricle failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internal Jugular Vein Distensibility and Pleth Variability Index for Evaluating Fluid Responsiveness
Assessment of intravascular volume status is crucial in order to predict the efficacy of volume status in major abdominal surgery. The aim of the study is to verify the feasibility and usefulness of the internal jugular vein distensibility index as an adjunct to the pleth variebility index(PVI) to predict fluid responsiveness in major abdominal surgery.
Read the detailed description
Forty patients above age 18 and ASA status I-III who are undergoing major abdominal surgery will be enrolled in the study. patients with right heart failure, arrythmia, severe valve stenosis or regurgitation will be excluded. After induction of general anesthesia, when the patients are hemodynamically stabilised, PVI and jugular vein distensibility will be calculated and recorded. after volume load with 500 ml gel infusion(in 15 min), measurements will be repeated within 10 minutes and recorded. Patients will be allocated to 2 groups according to the change in mean arterial pressure(MAP) after volume expansion: Responders will be defined as an increase in MAP by >%10; while nonresponders will be defined as an increase in MAP <%10 or decrease in MAP.
- Conditions
- Intravascular Volume
- Being tested
- Assessment of fluid responsiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of fluid responsivenessProcedure or surgery
assessment of intravascular volume status using pleth variebility index and internal jugular vein distensibility in major abdominal surgery
| Study group | Role | What they receive |
|---|---|---|
| fluid responsiveness | Assessment of fluid responsiveness using pleth variebility index and jugular vein distensibility in patients undergoing major abdominal surgery Receives: Procedure: Assessment of fluid responsiveness |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with significant change in VJI distensibility and pleth variebility index
volume responders with significant change in jugular vein distensibility and pleth variebility index
Measured: during surgery at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start1 Feb 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravascular VolumeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tepecik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MELTEM CAKMAK, Tepecik Training and Research Hospital
- Investigators
- Yucel Karaman, ass. prof, Study chair, Tepecik TRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673475
- Sponsor's protocol ID
- Meltem Cakmak
- Status last verified
- Nov 2018
- First submitted
- 24 Aug 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Jugular Vein Distensibility and Pleth Variability Index for Evaluating Fluid Responsiveness
- ClinicalTrials.gov ID
- NCT03673475
- Acronym / sponsor ID
- Meltem Cakmak
- Conditions
- Intravascular Volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tepecik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 17 Sep 2018 (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.
Assessment of intravascular volume status is crucial in order to predict the efficacy of volume status in major abdominal surgery. The aim of the study is to verify the feasibility and usefulness of the internal jugular vein distensibility index as an adjunct to the pleth variebility index(PVI) to predict fluid responsiveness in major abdominal surgery.
Detailed description
Forty patients above age 18 and ASA status I-III who are undergoing major abdominal surgery will be enrolled in the study. patients with right heart failure, arrythmia, severe valve stenosis or regurgitation will be excluded. After induction of general anesthesia, when the patients are hemodynamically stabilised, PVI and jugular vein distensibility will be calculated and recorded. after volume load with 500 ml gel infusion(in 15 min), measurements will be repeated within 10 minutes and recorded. Patients will be allocated to 2 groups according to the change in mean arterial pressure(MAP) after volume expansion: Responders will be defined as an increase in MAP by >%10; while nonresponders will be defined as an increase in MAP <%10 or decrease in MAP.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fluid responsiveness | – | Procedure: Assessment of fluid responsivenessAssessment of fluid responsiveness using pleth variebility index and jugular vein distensibility in patients undergoing major abdominal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing major abdominal surgery
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists(ASA) physical status I-III patients
- patients undergoing major abdominal surgery
Key exclusion criteria (2 listed)
- arrythmia
- severe right ventricle failure
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 |
|---|---|---|
| Assessment of fluid responsivenessassessment of intravascular volume status using pleth variebility index and internal jugular vein distensibility in major abdominal surgery | Procedure or surgery | fluid responsiveness |
Primary outcome
number of patients with significant change in VJI distensibility and pleth variebility index
Time frame: during surgery at day 0
volume responders with significant change in jugular vein distensibility and pleth variebility index
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 27 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Intravascular Volume
Active, not recruitingObservational study
Albumin Utilization in Adult Cardiac Surgical Patients: Retrospective
Cardiovascular Surgical Procedures, Albumin
Active, not recruitingObservational study
Albumin Utilization in Adult Cardiac Surgical Patients : A Multicentre Prospective Cohort Study
Antithrombin III Levels, Albumin Levels
RecruitingObservational study
IVC Collapsibility Index in Lumbar Stabilization Surgery
Lumbar Spine Surgery, Hemodynamic Changes
Active, not recruitingObservational study
Comparison Between Perfusion Index and Pulse Pressure Variability for Prediction of Intravascular Volume During Major Abdominal Surgeries
Comparison Between Perfusion Index and Pulse Pressure Variability for Prediction of Intravascular Volume During Major Abdominal Surgeries
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.
Yucel Karaman, ass. prof study chair
Tepecik TRH
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 Intravascular Volume, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 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 27 Nov 2018. 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 Turkey (Türkiye). 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?
number of patients with significant change in VJI distensibility and pleth variebility index (time frame: during surgery at day 0). 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 Nov 2018.