NCT03094390

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

April 4, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2018

Completed
Last Updated

June 13, 2019

Status Verified

June 1, 2019

Enrollment Period

1.4 years

First QC Date

March 20, 2017

Last Update Submit

June 11, 2019

Conditions

Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

  • Total thoracic fluid content (TFC)

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

    5 minutes before spontaneous breathing trial

Secondary Outcomes (3)

  • rapid shallow breathing index

    5 minutes before spontaneous breathing trial.

  • P/F ratio

    5 minutes before spontaneous breathing trial and 5 minutes before patient extubation

  • fluid balance

    during the last 24 hours before the weaning trial

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Study Officials

  • Ahmed Mukhtar, Professor

    Head of research committee section in anesthesia department

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Lecturer of anesthesia and critical care medicine

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 29, 2017

Study Start

April 4, 2017

Primary Completion

September 1, 2018

Study Completion

September 10, 2018

Last Updated

June 13, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)