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

The Impact of Thoracic Fluid Content Measured by Cardiometry on 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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation Complication

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total thoracic fluid content (TFC)	the value of TFC measured by cardiometry device (in liters)	5 minutes before spontaneous breathing trial

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rapid shallow breathing index	the respiratory rate divided by the tidal volume (in liters)	5 minutes before spontaneous breathing trial.
P/F ratio	pressure of arterial oxygen (in mmHg) divided by fraction of inspired oxygen	5 minutes before spontaneous breathing trial and 5 minutes before patient extubation
fluid balance	the total fluid intake minus the fluid output (in liters)	during the last 24 hours before the weaning trial

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 10, 2018

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): June 13, 2019
• Last Update Submitted That Met QC Criteria: June 11, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: N-18-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No