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NCT Number: NCT03452046

Inferior Vena Cava Indexes in Positive Pressure Supports

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.

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Key information

Conditions

Positive-Pressure Respirations Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tepecik Research and Training Hospital

Izmir, Konak, 35110, Turkey (Türkiye)

About this study

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:

  • PS 10 mmHg-PEEP 5 mmHg,
  • PS 0 mmHg- PEEP 5 mmHg
  • PS 10 mmHg- PEEP 0 mmHg.
  • T-tube (PS 0 mmHg-PEEP 0 mmHg)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IVC diametres

Other

Other names: Measurement of central venous pressure, Positive pressure supports

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Tepecik Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 2, 2018
Registry last updated
Apr 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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