Lung; CongestiveNCT05947942
Thoracic Fluid Content for Weaning Parameters
An observational study of Lung; Congestive, run by Benha University at 1 site in Egypt.
Trial summary
The study aims to compare the thoracic fluid content measured by electrical cardiometry versus the diaphragmatic excursion measured by ultrasound for prediction of weaning success in patients having lung congestion. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung; Congestive
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2023to 20 Apr 2024
- 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 70 years
- All sexes
- Adult, Older adult
Study population: The study will be conducted on 100 patients admitted to critical care department at Benha university hospitals with lung congestion. Patients who are candidate for weaning from invasive mechanical ventilation (after 48 h) and who agree to participate in the study will be involved.
Who may be able to join
- • Patients of both genders aged 18-70 years old.
- Acute Physiology and Chronic Health Evaluation II (APACHE II) score
- Patients with congested lung including; Acute exacerbation of COPD patients with acute respiratory failure (PaO2/FiO2 ratio ≤300 or PaCO2 ≥ 50 mm Hg at intubation), pneumonia, chronic kidney disease, heart failure (New York Heart Association Classification III, IV) who will be candidate for weaning from invasive mechanical ventilation according to the treating physician's judgement using the ICU weaning protocol.
Who cannot join
- • Patients younger than 18 years or older than 70 years
- Refusal to participate.
- Obesity (BMI≥35).
- Pregnancy.
- Patients with pneumothorax, pleural, or pericardial effusion, lung contusion, and thoracotomy.
- Hepatic dysfunction.
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- history or new detection of paralysis (no movement) or paradoxical movement of a single hemidiaphragm.
- preexisting cervical spinal injury, history of neuromuscular disorders
- Patients with injuries, burns, or wounds which precluded the proper application of the device electrodes will be also excluded from the study.
- Mechanical ventilation < 48 hrs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thoracic Fluid Content by Electrical Cardiometry Versus Diaphragmatic Excursion by Ultrasound for Prediction of Weaning Success in Patients With Lung Congestion
The study aims to compare the thoracic fluid content measured by electrical cardiometry versus the diaphragmatic excursion measured by ultrasound for prediction of weaning success in patients having lung congestion.
Read the detailed description
lung congestion was defined as distention of blood vessels in the lungs and filling of the alveoli with fluid as a result of an infection, high blood pressure, or cardiac insufficiencies (i.e., inability of the heart to function adequately.
The process of weaning from ventilatory support takes almost 40% of the time spent on ventilator. Weaning indices like spontaneous tidal volumes, minute ventilation and rapid shallow breathing index, have been used extensively in clinical practice for weaning purposes . These parameters measure the overall respiratory volumes produced by the muscles of breathing and do not take into account the independent contribution of the diaphragm. During resting, the main muscle of breathing is the diaphragm .
Diaphragmatic excursion is the movement of the thoracic diaphragm during breathing. Normal diaphragmatic excursion should be 3-5 cm, but can be increased in well-conditioned persons to 7-8 cm. This measures the contraction of the diaphragm. Diaphragmatic excursion is positively correlated with lung inspiratory volumes and can accurately reflect the muscle strength and function . Diaphragmatic excursion is an index for respiratory muscle fatigue during the spontaneous breathing trial (SBT).
Thoracic fluid content (TFC) is one of the many variables measured by the ICON electrical cardiometry (EC) device. The ICON device is one relatively new proprietary implementation of impedance cardiography technology, which is also often called thoracic electrical bioimpedance .
Impedance cardiography is based on measuring the changes in total resistance of the thorax to electric current. The impedance to electric current is determined by the resistance of different tissues such as bone, muscles, and fluids. The fluid compartment is considered the dynamic component that would cause short term changes in thoracic impedance . TFC is calculated as the reciprocal of the total thoracic impedance and is considered a numerical measure of total (intravascular and extravascular) thoracic fluid . Although TFC is a measure of both extra and intravascular thoracic fluid, it might provide an estimate of the increase in intrathoracic fluids such as to facilitate the risk of pulmonary congestion , we hypothesized that TFC, as an estimate of lung congestion, can serve as predictor for weaning outcomes in critically ill patient.
- Conditions
- Lung; Congestive
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracic fluid content by electrical cardiometry versus diaphragmatic excursion by Ultrasound for prediction of weaning success in patients with lung congestion
compare the thoracic fluid content measured by electrical cardiometry versus the diaphragmatic excursion measured by ultrasound for prediction of weaning success in patients having lung congestion.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start20 May 2023
- Primary completion20 Mar 2024 (estimated)
- Study completion20 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung; CongestiveStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shawky Elshaer, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947942
- Sponsor's protocol ID
- MD.10.4.2023
- Status last verified
- Jul 2023
- First submitted
- 9 Jul 2023
- Last updated
- 17 Jul 2023
- Results posted
- 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 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Fluid Content by Electrical Cardiometry Versus Diaphragmatic Excursion by Ultrasound for Prediction of Weaning Success in Patients With Lung Congestion
- ClinicalTrials.gov ID
- NCT05947942
- Acronym / sponsor ID
- MD.10.4.2023
- Conditions
- Lung; Congestive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 20 May 2023 (actual)
- Primary completion
- 20 Mar 2024 (estimated)
- Study completion
- 20 Apr 2024 (estimated)
- First posted
- 17 Jul 2023 (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.
The study aims to compare the thoracic fluid content measured by electrical cardiometry versus the diaphragmatic excursion measured by ultrasound for prediction of weaning success in patients having lung congestion.
Detailed description
lung congestion was defined as distention of blood vessels in the lungs and filling of the alveoli with fluid as a result of an infection, high blood pressure, or cardiac insufficiencies (i.e., inability of the heart to function adequately.
The process of weaning from ventilatory support takes almost 40% of the time spent on ventilator. Weaning indices like spontaneous tidal volumes, minute ventilation and rapid shallow breathing index, have been used extensively in clinical practice for weaning purposes . These parameters measure the overall respiratory volumes produced by the muscles of breathing and do not take into account the independent contribution of the diaphragm. During resting, the main muscle of breathing is the diaphragm .
Diaphragmatic excursion is the movement of the thoracic diaphragm during breathing. Normal diaphragmatic excursion should be 3-5 cm, but can be increased in well-conditioned persons to 7-8 cm. This measures the contraction of the diaphragm. Diaphragmatic excursion is positively correlated with lung inspiratory volumes and can accurately reflect the muscle strength and function . Diaphragmatic excursion is an index for respiratory muscle fatigue during the spontaneous breathing trial (SBT).
Thoracic fluid content (TFC) is one of the many variables measured by the ICON electrical cardiometry (EC) device. The ICON device is one relatively new proprietary implementation of impedance cardiography technology, which is also often called thoracic electrical bioimpedance .
Impedance cardiography is based on measuring the changes in total resistance of the thorax to electric current. The impedance to electric current is determined by the resistance of different tissues such as bone, muscles, and fluids. The fluid compartment is considered the dynamic component that would cause short term changes in thoracic impedance . TFC is calculated as the reciprocal of the total thoracic impedance and is considered a numerical measure of total (intravascular and extravascular) thoracic fluid . Although TFC is a measure of both extra and intravascular thoracic fluid, it might provide an estimate of the increase in intrathoracic fluids such as to facilitate the risk of pulmonary congestion , we hypothesized that TFC, as an estimate of lung congestion, can serve as predictor for weaning outcomes in critically ill patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted on 100 patients admitted to critical care department at Benha university hospitals with lung congestion. Patients who are candidate for weaning from invasive mechanical ventilation (after 48 h) and who agree to participate in the study will be involved.
Key inclusion criteria (3 listed)
- • Patients of both genders aged 18-70 years old.
Key exclusion criteria (10 listed)
- • Patients younger than 18 years or older than 70 years
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
Thoracic fluid content by electrical cardiometry versus diaphragmatic excursion by Ultrasound for prediction of weaning success in patients with lung congestion
Time frame: 1 year
compare the thoracic fluid content measured by electrical cardiometry versus the diaphragmatic excursion measured by ultrasound for prediction of weaning success in patients having lung congestion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- 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.
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 Lung; Congestive, run by Benha 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 3 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: status not confirmed, as of the sponsor's last update on 17 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shawky Elshaer (01024542387, elshaershawky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoracic fluid content by electrical cardiometry versus diaphragmatic excursion by Ultrasound for prediction of weaning success in patients with lung congestion (time frame: 1 year). 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 17 Jul 2023.