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

Mechanical Ventilation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03094390
• Other study ID #: N-18-2017
• Status: Completed
• Start date: April 4, 2017
• Est. completion date: September 10, 2018

Study information

• Verified date: June 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 10, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total thoracic fluid content (TFC)	the value of TFC measured by cardiometry device (in liters)	5 minutes before spontaneous breathing trial
Secondary	rapid shallow breathing index	the respiratory rate divided by the tidal volume (in liters)	5 minutes before spontaneous breathing trial.
Secondary	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
Secondary	fluid balance	the total fluid intake minus the fluid output (in liters)	during the last 24 hours before the weaning trial