Mechanical Ventilation ComplicationNCT03094390
Thoracic Fluid Content in Prediction of Failure of Weaning From Mechanical Ventilation
An observational study of Mechanical Ventilation Complication, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Apr 2017to 10 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years or more scheduled for a spontaneous weaning trial (SBT) using pressure support ventilation.
Who may be able to join
- Patients aged 18 years or more scheduled for a spontaneous weaning trial (SBT) on pressure support ventilation.
Who cannot join
- Age < 18 years old.
- Pregnant patients.
- Neuromuscular disease (stroke, myasthenia gravis and Guillain-Barrésyndrome).
- Tracheostomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mechanical Ventilation Complication
What is being measured
The primary outcome is the main question the study is designed to answer.
Total thoracic fluid content (TFC)
the value of TFC measured by cardiometry device (in liters)
Measured: 5 minutes before spontaneous breathing trial
Secondary outcomes (3)
rapid shallow breathing index
the respiratory rate divided by the tidal volume (in liters)
Measured: 5 minutes before spontaneous breathing trial.
P/F ratio
pressure of arterial oxygen (in mmHg) divided by fraction of inspired oxygen
Measured: 5 minutes before spontaneous breathing trial and 5 minutes before patient extubation
fluid balance
the total fluid intake minus the fluid output (in liters)
Measured: during the last 24 hours before the weaning trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start4 Apr 2017
- Primary completion1 Sep 2018
- Study completion10 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
- Investigators
- Ahmed Mukhtar, Professor, Study director, Head of research committee section in anesthesia department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094390
- Sponsor's protocol ID
- N-18-2017
- Status last verified
- Jun 2019
- First submitted
- 20 Mar 2017
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Thoracic Fluid Content Measured by Cardiometry on Prediction of Failure of Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT03094390
- Acronym / sponsor ID
- N-18-2017
- Conditions
- Mechanical Ventilation Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or more scheduled for a spontaneous weaning trial (SBT) using pressure support ventilation.
Key inclusion criteria (1 listed)
- Patients aged 18 years or more scheduled for a spontaneous weaning trial (SBT) on pressure support ventilation.
Key exclusion criteria (4 listed)
- Age < 18 years old.
- Pregnant patients.
- Neuromuscular disease (stroke, myasthenia gravis and Guillain-Barrésyndrome).
- Tracheostomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total thoracic fluid content (TFC)
Time frame: 5 minutes before spontaneous breathing trial
the value of TFC measured by cardiometry device (in liters)
3 secondary outcomes
rapid shallow breathing index
Time frame: 5 minutes before spontaneous breathing trial.
P/F ratio
Time frame: 5 minutes before spontaneous breathing trial and 5 minutes before patient extubation
fluid balance
Time frame: during the last 24 hours before the weaning trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Mukhtar, Professor study director
Head of research committee section in anesthesia department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Complication, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total thoracic fluid content (TFC) (time frame: 5 minutes before spontaneous breathing trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019.