Evaluating the Fluid Balance of Mechanically Ventilated Patients by Ultrasonography

June 28, 2017 updated by: Tomasz Skladzien, Jagiellonian University

Measurement of the Inferior Vena Cava as a Method of Evaluating the Fluid Balance of Mechanically Ventilated Patients

ratio of the diameter of inferior vena cava to the diameter of the thoracic aorta (IVC / Ao) depends on the daily balance of fluids.

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.

Detailed Description

During the routine abdominal ultrasound, the basilar and abdominal aorta were measured using a Sparq Philips ultrasonograph with a convex probe set in abdominal mode. All measurements were performed in one patient by the same operator who were experienced and performed the appropriate course of ultrasonography. The IVC and abdominal aorta were visualized using a paramedian long-axis view via a subcostal approach according to the methodology described by the American Society of Echocardiography. Inferior vena cava width was assessed at an interval of approximately 1 cm distal from connection of the hepatic vein to the inferior vena cava. No significant changes were observed in the width of the inferior vena cava during various respiratory phases, because of the positive pressure ventilation. The widest value was always chosen for the data. The assessment of the width of the abdominal aorta was performed above arise of the celiac trunk, at the height of the vein of the lower vena cava. The width of the inferior vena cava and the abdominal aorta was assessed using transthoracic ultrasound for the following five days. Daily differences in the amount of fluid intake and lost was recorded. CVP measurement was performed.

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.
57

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

  • Poland
    • Małopolskie
      • Cracow, Małopolskie, Poland, 31-501
        • University 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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

There were 57 mechanically ventilated patients examined. 8 patients were excluded from the study because of spontaneous ventilation within 5 days of data collection. Two patients died during the study. Five patients failed to obtain satisfactory results of imaging of vascular structures during subsequent examination. Data from 42 patients were analyzed.

Description

Inclusion Criteria:

  • patients who were hospitalized in the Intensive Care Unit
  • severe respiratory failure requiring mechanical ventilation

Exclusion Criteria:

  • spontaneous breathing,
  • severe vascular disease,
  • increased intra-abdominal pressure,
  • cardiac pacemaker
  • cardioverter defibrillator

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

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.
IVC/Ao
ultrasound, the inferior vena cava and abdominal aorta were measured. Inferior vena cava width was assessed at an interval of approximately 1 cm distal from connection of the hepatic vein to the inferior vena cava. No significant changes were observed in the width of the inferior vena cava during various respiratory phases, because of the positive pressure ventilation. The widest value was always chosen for the data. The assessment of the width of the abdominal aorta was performed above arise of the celiac trunk, at the height of the vein of the lower vena cava.

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
fluid balance
Time Frame: 1 day
the width of the vena cava and abdominal aorta was measured every day morning. The difference in in taken and excreted fluids
1 day

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.
Jagiellonian University

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: Tomasz Skladzien, Ph.D., Jagiellonian University

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

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.
July 1, 2015

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.
January 1, 2017

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.
January 1, 2017

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).
June 24, 2017

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.
June 28, 2017

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.
July 2, 2017

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.
July 2, 2017

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.
June 28, 2017

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.
June 1, 2017

More Information

Terms related to this study

Keywords

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.
  • 122.6120.85.2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The assessment of the width of the abdominal aorta was performed above arise of the celiac trunk, at the height of the vein of the lower vena cava. The width of the inferior vena cava and the abdominal aorta was assessed using transthoracic ultrasound for the following five days. Daily differences in the amount of fluid intake and lost was recorded. CVP measurement was performed.

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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