Thoracic Fluid ContentNCT05272982
Thoracic Fluid Content by Electrical Cardiometry Versus Lung Ultrasound in Mechanically Ventilated Patients
An observational study of Thoracic Fluid Content and Electrical Cardiometry, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare the accuracy of the total thoracic fluid content (TFC) measured by electrical cardiometry with accuracy of lung ultrasound score in prediction of weaning outcome in mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thoracic Fluid Content, Electrical Cardiometry, Lung Ultrasound
- What is being tested?
- Thoracic fluid content by electrical cardiometry group and Ultrasound examination group
- How many people
- 85 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2022to 25 Dec 2023
- How long will I take part?
- 2 Days
- 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 to 65 years
- All sexes
- Adult, Older adult
Study population: 85 mechanically ventilated patients for ≥ 48 hours aged 18 years or more of both sex who fulfilled the weaning readiness criteria and scheduled for spontaneous breathing trial using pressure support ventilation.
Who may be able to join
- 85 mechanically ventilated patients for ≥ 48 hours
- Aged 18-65 years
- Both sex
- Fulfilled the weaning readiness criteria
- Scheduled for spontaneous breathing trial (SBT) using pressure support ventilation.
Who cannot join
- Acute respiratory distress syndrome (ARDS) patients.
- Interstitial lung fibrosis.
- Patients with lung resection.
- Pulmonary embolism.
- Patients with fluid overload due to heart, renal or hepatic failure.
- Cardiac patients with ejection fraction less than 40%, cardiomyopathy, congenital or valvular heart diseases.
Show all 10Show fewer
- Pneumothorax.
- Pleural or pericardial effusion.
- Pregnancy.
- Patients with injuries, burns, or wounds which precluded the proper application of the device electrodes or the ultrasound transducer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thoracic Fluid Content by Electrical Cardiometry Versus Lung Ultrasound Score as Predictors of Weaning Outcome in Mechanically Ventilated Intensive Care Patients
This study aims to compare the accuracy of the total thoracic fluid content (TFC) measured by electrical cardiometry with accuracy of lung ultrasound score in prediction of weaning outcome in mechanically ventilated patients.
Read the detailed description
Weaning of patients from mechanical ventilation remains one of the critical decisions in the intensive care unit. Earlier patient weaning from mechanical ventilation is recommended to avoid complications of prolonged mechanical ventilation; however, premature weaning might result in extubation failure which is, independently, associated with poor outcomes.
Screening for eligibility is the first step in the weaning process, followed by the spontaneous breathing trial (SBT). Various indices should be checked carefully before starting a spontaneous breathing trial to ensure adequate oxygenation, ventilation, and airway reflexes. However, nearly one-third of patients fail and are reintubated despite fulfillment of all the current weaning pre-requisites.
- Conditions
- Thoracic Fluid Content, Electrical Cardiometry, Lung Ultrasound, Mechanical Ventilation, Intensive Care Unit
- Being tested
- Thoracic fluid content by electrical cardiometry group, Ultrasound examination group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic fluid content by electrical cardiometry groupDiagnostic test
Thoracic fluid content will be measured using electrical cardiometry device (ICON ® Cardiotronics, Inc., La Jolla, CA 92307; Osyka Medical GmbH, Berlin, and Germany, model C3, Serial no: 1725303). The ICON device will be connected to four electrocardiogram electrodes which will be placed over patients' skin after cleaning with alcohol at the neck below the left ear, just above the left clavicular midpoint, and two electrodes at left mid-axillary line one at the level of the xiphoid process, and the other electrode 5 cm below this point. The thoracic fluid content will be observed for 30 s and the average of the highest and lowest values will be recorded.
Ultrasound examination groupDiagnostic test
The 12-region technique for lung assessment will be performed using Philips ® (CX50 - Extreme edition) equipped with phased array transducer. B-line will be defined as laser like vertical hyperechoic artefact which extends between the pleural line and the bottom of the screen and moves with respiratory movements. Two types of B-lines will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Successful weaning group | Criteria of weaning included resolution of the primary cause of intubation, adequate cough without excessive tracheobronchial secretions, PaO2 > 60 mmHg with positive end-expiratory pressure ≤ 8 cmH2O, fraction of inspired oxygen ≤ 0.4, respiratory rate < 30 per minute, appropriate pH for patients' baseline respiratory status, and stable cardiovascular status. Receives: Diagnostic Test: Thoracic fluid content by electrical cardiometry group; Diagnostic Test: Ultrasound examination group | |
| Failed weaning group | Weaning failure will be defined as a patient need for reintubation or noninvasive ventilation within 48 h after extubation due to the presence of one or more of the following criteria: altered mental status tachypnea (respiratory rate more than 35 breaths per minute), oxygen saturation less than 90% or PaO2 less than 60 mmHg on a fraction of inspired oxygen of 40%, an apparent increase in accessory respiratory muscle activity, evident facial signs of respiratory distress and hemodynamic instability (Heart rate >140 b/min, systolic blood pressure >180 or < 90mmHg ) Receives: Diagnostic Test: Thoracic fluid content by electrical cardiometry group; Diagnostic Test: Ultrasound examination group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the area under the curve (AUC) of receiver operating characteristic (ROC) for thoracic fluid content (TFC) and lung ultrasound score.
Comparing the area under the curve (AUC) of receiver operating characteristic (ROC) for thoracic fluid content (TFC) and lung ultrasound score (minimum score, normal lungs: 0; maximum score, both consolidated lungs: 36) in prediction of weaning outcome in mechanically ventilated patients.
Measured: Two days after the extubation
Secondary outcomes (3)
Prediction of weaning through rapid shallow breathing index (RSBI)
Rapid shallow breathing index (RSBI) [respiratory rate/tidal volume (in liters)] will be recorded before the initiation of spontaneous breathing trial (SBT) and before extubation.
Measured: Two days after the extubation
The degree of lung compliance
Lung compliance will be recorded before initiation of spontaneous breathing trial and before extubation.
It is defined as the measure of the lung's ability to stretch and expand (distensibility of elastic tissue) and is calculated using the equation (V/ΔP; where ΔV is the change in volume, and ΔP is the change in pleural pressure.
Measured: Before initiation of spontaneous breathing trial and before extubation.
Cumulative fluid balance
Cumulative fluid balance at the day of spontaneous breathing trial (equals the total fluid intake minus the fluid output) will be recorded.
Measured: within 24 hours of spontaneous breathing trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start25 Mar 2022
- Primary completion25 Dec 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Fluid ContentStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 85 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Rabie Amer, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272982
- Sponsor's protocol ID
- 35237/1/22
- Status last verified
- Apr 2025
- First submitted
- 14 Feb 2022
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Fluid Content by Electrical Cardiometry Versus Lung Ultrasound Score as Predictors of Weaning Outcome in Mechanically Ventilated Intensive Care Patients
- ClinicalTrials.gov ID
- NCT05272982
- Acronym / sponsor ID
- 35237/1/22
- Conditions
- Thoracic Fluid Content, Electrical Cardiometry, Lung Ultrasound, Mechanical Ventilation, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 10 Mar 2022 (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 compare the accuracy of the total thoracic fluid content (TFC) measured by electrical cardiometry with accuracy of lung ultrasound score in prediction of weaning outcome in mechanically ventilated patients.
Detailed description
Weaning of patients from mechanical ventilation remains one of the critical decisions in the intensive care unit. Earlier patient weaning from mechanical ventilation is recommended to avoid complications of prolonged mechanical ventilation; however, premature weaning might result in extubation failure which is, independently, associated with poor outcomes.
Screening for eligibility is the first step in the weaning process, followed by the spontaneous breathing trial (SBT). Various indices should be checked carefully before starting a spontaneous breathing trial to ensure adequate oxygenation, ventilation, and airway reflexes. However, nearly one-third of patients fail and are reintubated despite fulfillment of all the current weaning pre-requisites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successful weaning group | – | Diagnostic Test: Thoracic fluid content by electrical cardiometry group, Diagnostic Test: Ultrasound examination groupCriteria of weaning included resolution of the primary cause of intubation, adequate cough without excessive tracheobronchial secretions, PaO2 > 60 mmHg with positive end-expiratory pressure ≤ 8 cmH2O, fraction of inspired oxygen ≤ 0.4, respiratory rate < 30 per minute, appropriate pH for patients' baseline respiratory status, and stable cardiovascular status. |
| Failed weaning group | – | Diagnostic Test: Thoracic fluid content by electrical cardiometry group, Diagnostic Test: Ultrasound examination groupWeaning failure will be defined as a patient need for reintubation or noninvasive ventilation within 48 h after extubation due to the presence of one or more of the following criteria: altered mental status tachypnea (respiratory rate more than 35 breaths per minute), oxygen saturation less than 90% or PaO2 less than 60 mmHg on a fraction of inspired oxygen of 40%, an apparent increase in accessory respiratory muscle activity, evident facial signs of respiratory distress and hemodynamic instability (Heart rate >140 b/min, systolic blood pressure >180 or < 90mmHg ) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 85 mechanically ventilated patients for ≥ 48 hours aged 18 years or more of both sex who fulfilled the weaning readiness criteria and scheduled for spontaneous breathing trial using pressure support ventilation.
Key inclusion criteria (5 listed)
- 85 mechanically ventilated patients for ≥ 48 hours
- Aged 18-65 years
- Both sex
- Fulfilled the weaning readiness criteria
- Scheduled for spontaneous breathing trial (SBT) using pressure support ventilation.
Key exclusion criteria (10 listed)
- Acute respiratory distress syndrome (ARDS) patients.
- Interstitial lung fibrosis.
- Patients with lung resection.
- Pulmonary embolism.
- Patients with fluid overload due to heart, renal or hepatic failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic fluid content by electrical cardiometry groupThoracic fluid content will be measured using electrical cardiometry device (ICON ® Cardiotronics, Inc., La Jolla, CA 92307; Osyka Medical GmbH, Berlin, and Germany, model C3, Serial no: 1725303). The ICON device will be connected to four electrocardiogram electrodes which will be placed over patients' skin after cleaning with alcohol at the neck below the left ear, just above the left clavicular midpoint, and two electrodes at left mid-axillary line one at the level of the xiphoid process, and the other electrode 5 cm below this point. The thoracic fluid content will be observed for 30 s and the average of the highest and lowest values will be recorded. | Diagnostic test | Failed weaning group, Successful weaning group |
| Ultrasound examination groupThe 12-region technique for lung assessment will be performed using Philips ® (CX50 - Extreme edition) equipped with phased array transducer. B-line will be defined as laser like vertical hyperechoic artefact which extends between the pleural line and the bottom of the screen and moves with respiratory movements. Two types of B-lines will be evaluated. | Diagnostic test | Failed weaning group, Successful weaning group |
Primary outcome
Comparing the area under the curve (AUC) of receiver operating characteristic (ROC) for thoracic fluid content (TFC) and lung ultrasound score.
Time frame: Two days after the extubation
Comparing the area under the curve (AUC) of receiver operating characteristic (ROC) for thoracic fluid content (TFC) and lung ultrasound score (minimum score, normal lungs: 0; maximum score, both consolidated lungs: 36) in prediction of weaning outcome in mechanically ventilated patients.
3 secondary outcomes
Prediction of weaning through rapid shallow breathing index (RSBI)
Time frame: Two days after the extubation
The degree of lung compliance
Time frame: Before initiation of spontaneous breathing trial and before extubation.
Cumulative fluid balance
Time frame: within 24 hours of spontaneous breathing 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 15 Apr 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the corresponding author.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thoracic Fluid Content and Electrical Cardiometry, run by Tanta 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 5 inclusion and 10 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 15 Apr 2025. 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?
Comparing the area under the curve (AUC) of receiver operating characteristic (ROC) for thoracic fluid content (TFC) and lung ultrasound score. (time frame: Two days after the extubation). 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 15 Apr 2025.