Inferior Vena Cava Indexes in Positive Pressure Supports

April 23, 2018 updated by: Aykut Saritas, Tepecik Training and Research Hospital

Inferior Vena Cava Indexes (Collapsibility, Distensibility, Delta) in Positive Pressure Supports and Prediction Ability of Intravascular Volume Status in ICU Patients

Collapsibility (CI-IVC), distensibility (dIVC) and delta (ΔIVC) indices, which are dynamic measures of inferior vena cava (IVC) diameter, are used to assess the intravascular volume status in critically ill patients. Positive pressure support (PS) has been shown to induce IVC diameter distention by increasing intrathoracic pressure, and high positive expiratory pressure (PEEP) decreases the CI-IVC percentage (4). During Triggered positive pressure support it is necessary to clarify which IVC index is valid for measuring the volume status.it is aimed to compare the IVC indexes (CI-IVC, DIVC, ΔIVC), positive rate of change with pressure, correlation with central venous pressure and accurate prediction of volume status in patients with different positive pressure support.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The IVC diameters at different pressure supports were measured by the same clinician after obtaining a clear image of where the US and IVC measurements were made and the probe stabilization was achieved. He performed the procedure of changing the pressure supports, a blind independent intensive care physician without working, and recorded the applied pressure supports respectively. The different pressure supports applied are as follows:

  1. PS 10 mmHg-PEEP 5 mmHg,
  2. PS 0 mmHg- PEEP 5 mmHg
  3. PS 10 mmHg- PEEP 0 mmHg.
  4. T-tube (PS 0 mmHg-PEEP 0 mmHg)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Konak
      • Izmir, Konak, Turkey, 35110
        • Tepecik Research and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Inpatient sample

Description

Inclusion Criteria:

  • Age>18 years
  • Current use of mechanical ventilation through an endotracheal tube.

Exclusion Criteria:

  • Profound Hypoxia defined as a fraction of inspired oxygen requirement >90% or a PEEP >10 mmHg
  • Patient-ventilator desynchrony or active agitation
  • Unstable O2 requirement
  • Cardiovascular instability
  • Current PEEP requirements of >10 mmHg
  • Current oxygen saturation (SpO2) of <88%.
  • High intra abdominal pressure
  • Right cardiac failure
  • Morbid obesity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PS 10 mmHg, PEEP 5 mmHg
IVC diametres, CI-IVC, distensibility and delta index measurements using by ultrasound. Central venous pressure correlation with IVC index
Other: IVC diametres
Other Names:
  • Measurement of central venous pressure
  • Positive pressure supports
PS 10 mmHg PEEP 0 mmHg
IVC diametres, CI-IVC, distensibility and delta index measurements using by ultrasound. Central venous pressure correlation with IVC index
Other: IVC diametres
Other Names:
  • Measurement of central venous pressure
  • Positive pressure supports
PS 0 mmHg PEEP 5 mmHg
IVC diametres, CI-IVC, distensibility and delta index measurements using by ultrasound. Central venous pressure correlation with IVC index
Other: IVC diametres
Other Names:
  • Measurement of central venous pressure
  • Positive pressure supports
t tube (PS 0 mmHg PEEP 0mmHg)
IVC diametres, CI-IVC, distensibility and delta index measurements using by ultrasound. Central venous pressure correlation with IVC index
Other: IVC diametres
Other Names:
  • Measurement of central venous pressure
  • Positive pressure supports

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determine the effect of positive pressure on IVC collapsibility index
Time Frame: 12 month
Determine the effect on CI-IVC of an increase in positive end-expiratory pressure and pressure support
12 month
Determine the effect of positive pressure on IVC distensibility index
Time Frame: 12 month
Determine the effect on distensibility index of an increase in positive end-expiratory pressure and pressure support
12 month
Determine the effect of positive pressure on IVC delta index
Time Frame: 12 month
Determine the effect on delta index of an increase in positive end-expiratory pressure and pressure support
12 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Determine the effect of positive pressure on central venous pressure
Time Frame: 12 month
Determine the effect on central venous pressure of an increase in positive end-expiratory pressure and pressure support
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tepecik Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tepecik Training and Research Hospital, Tepecik Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Tepecik

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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