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Completed

NCT Number: NCT03094390

Thoracic Fluid Content in Prediction of Failure of Weaning From Mechanical Ventilation

This study aims to test the accuracy of the total thoracic fluid content (TFC) measured by cardiometry can predict weaning failure. Area under receiver operating characteristic curve (AUROC) will be determined, sensitivity, specificity, and best cutoff value will be calculated for TFC in prediction of weaning failure.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairo University

Cairo, Egypt

About this study

Weaning from mechanical ventilation is a serious and challenging process in critical care practice. Weaning failure is associated with poor patient outcomes. Increased mortality in patients with failed weaning was due to development of complications related to re-intubation. Detection and correction of the cause of failed spontaneous breathing trial (SBT) helps the intensives to improve the outcome of the next trials.

Fluid overload and positive cumulative fluid balance is a risk factor of weaning failure in both cardiac and non-cardiac patients.

Many tools for prediction of lung congestion as a risk factor for weaning failure have been reported. The gold standard for detection of cardiac cause of weaning failure was pulmonary artery catheter. More simple tools had been investigated for detection of cardiac cause of weaning failure in patients with or without previous cardiac dysfunction such as extravascular lung water and B-natriuretic peptide (BNP) levels.

Although measurement of extravascular lung water is a reliable tool for prediction of cardiac cause of weaning failure, it has the disadvantage of the need of advanced monitor with invasive arterial line. Bioreactance is a new technology used for measurement of cardiac output and total thoracic fluid content (TFC). More recently, electrical velocimetry is a newer technology with good performance in cardiac output monitoring. The use of electrical velocimetry in measurement of TFC has the advantage of being non-invasive with no need for advanced skills. The aim of this work is to validate the use of TFC (measured by electrical velocimetry) in prediction of weaning outcome.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 18 years or more scheduled for a spontaneous weaning trial (SBT) on pressure support ventilation.

Exclusion criteria

  • Age < 18 years old.
  • Pregnant patients.
  • Neuromuscular disease (stroke, myasthenia gravis and Guillain-Barrésyndrome).
  • Tracheostomy.

Treatment and study plan

Primary outcomes

  1. Total thoracic fluid content (TFC)

    Time frame: 5 minutes before spontaneous breathing trial

    the value of TFC measured by cardiometry device (in liters)

Secondary outcomes

  1. rapid shallow breathing index

    Time frame: 5 minutes before spontaneous breathing trial.

    the respiratory rate divided by the tidal volume (in liters)

  2. P/F ratio

    Time frame: 5 minutes before spontaneous breathing trial and 5 minutes before patient extubation

    pressure of arterial oxygen (in mmHg) divided by fraction of inspired oxygen

  3. fluid balance

    Time frame: during the last 24 hours before the weaning trial

    the total fluid intake minus the fluid output (in liters)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Impact of Thoracic Fluid Content Measured by Cardiometry on Prediction of Failure of Weaning From Mechanical Ventilation

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2017
Registry last updated
Jun 13, 2019

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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