Thoracic DiseasesNCT07100821
Thoracic Fluid Content as an Outcome Predictor in Intensive Care Unit
An observational study of Thoracic Diseases, run by Mansoura University Hospital at 1 site in Egypt.
Trial summary
Hemodynamic monitoring is measuring and monitoring the factors that influence the force and flow of the blood. It is an important aspect of patients care in operating rooms and critical care units. It aims to guide medical management so as to prevent or treat organ failure and improve the outcomes of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Diseases
- What is being tested?
- Hemodynamic parameters was measured by using electric cardiometry (ICON)
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Dec 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 years and older
- All sexes
- Adult, Older adult
Study population: Any Patient indicated for admission to respiratory critical care unit of chest medicine department at Mansoura University Hospitals whatever the indication was
Who may be able to join
- Age >18 years.
- Patients indicated for admission to respiratory critical care unit of chest medicine department at Mansoura University Hospitals whatever the indication was.
Who cannot join
- Patients with malignancy either primary or metastatic lung cancer.
- Advanced chronic pulmonary fibrosis.
- Pleural and or pericardial effusions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thoracic Fluid Content as an Outcome Predictor in Respiratory Intensive Care Unit
Hemodynamic monitoring is measuring and monitoring the factors that influence the force and flow of the blood. It is an important aspect of patients care in operating rooms and critical care units. It aims to guide medical management so as to prevent or treat organ failure and improve the outcomes of patients.
Read the detailed description
Hemodynamic monitoring is measuring and monitoring the factors that influence the force and flow of the blood. It is an important aspect of patients care in operating rooms and critical care units. It aims to guide medical management so as to prevent or treat organ failure and improve the outcomes of patients. This monitoring itself includes several different techniques and may range from invasive to less and even non-invasive techniques.
Critically ill patients are often hemodynamically unstable (or at risk of becoming unstable) owing to hypervolemia, cardiac dysfunction or alterations of vasomotor function, leading to organ dysfunction, deterioration into multi-organ failure and eventually death range from 15% to 25% of patients admitted to intensive care units.
Impedance cardiography (ICG) and Electrical Cardiometry (EC) are recently developed technologies to measure thoracic fluid content (TFC), cardiac output (CO) and other hemodynamic parameters. Both ICG and EC derive CO from measurements of Thoracic Electrical Bioimpedance (TEB).
One of the parameters examined by electrical cardiometry is thoracic fluid content(TFC) ,which is inversely associated with the patient's transthoracic electrical bioimpedance, and reflects the total (intravascular and extravascular) fluid volume contained in the chest cavity. A study concluded that electrical cardiometry monitoring indicated new possibility to anticipate prognosis of pneumonia patient. Increased thoracic fluid content value would relate to worse outcome of the patient like mortality and intensive care unit admission. Electrical cardiometry monitoring allows real-time measurements of thoracic fluid content without restraining the patient or invasive catheters.
In ARDS patients with cardiac comorbidities, TFC can distinguish between non-cardiogenic and cardiogenic pulmonary edema. In addition, TFC is helpful in the differential diagnosis of the mechanisms of respiratory failure. Thus, recently it was shown that TFC was greater in ARDS than in patients with atelectasis or pleural effusion. Therefore, depending on the TFC value, we can provide different therapeutic interventions.
- Conditions
- Thoracic Diseases
- Being tested
- Hemodynamic parameters was measured by using electric cardiometry (ICON)
- Keywords
- Thoracic fluid content, respiratory intensive care unit
- Medical subject headings
- Thoracic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodynamic parameters was measured by using electric cardiometry (ICON)Diagnostic test
Hemodynamic parameters was measured daily at 10 a.m by using ICON non-invasive cardiometer model C3 made in Germany by OSYPKA medical (figure 5) by placing the four sensors on the neck and left side of the thorax allow for the continuous measurement of the changes of electrical conductivity within the thorax parameters such as CO, TFC, SVV and FTC were calculated 3 times with 5-min intervals and stored on the device automatically.
| Study group | Role | What they receive |
|---|---|---|
| Patients indicated for admission to respiratory critical care unit of chest medicine department | 130 patients >18 years old were enrolled during the period from December 2023 to December 2024 Receives: Diagnostic Test: Hemodynamic parameters was measured by using electric cardiometry (ICON) |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of respiratory intensive care unit stay
Thoracic fluid content as an outcome predictor in length of stay in respiratory intensive care unit
Measured: 6 months
duration of invasive mechanical ventilation
Thoracic fluid content as an outcome predictor in duration of invasive mechanical ventilation
Measured: 6 months
Secondary outcomes (1)
mortality
Thoracic fluid content and hemodynamic parameters measurement as an outcome predictor in mortality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Dec 2023
- Primary completion1 Jun 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic DiseasesStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abd Elmoniem Mohamed, Mansoura University Hospital
- Investigators
- Mohamed AbdElmoniem, Principal investigator, Lecturer of chest medicine faculty of medicine Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100821
- Sponsor's protocol ID
- MS.19.12.354
- Status last verified
- Aug 2025
- First submitted
- 28 Jul 2025
- Last updated
- 13 Aug 2025
- 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 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Fluid Content as an Outcome Predictor in Respiratory Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07100821
- Acronym / sponsor ID
- MS.19.12.354
- Conditions
- Thoracic Diseases
- Keywords
- Thoracic fluid content, respiratory intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 3 Aug 2025 (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.
Hemodynamic monitoring is measuring and monitoring the factors that influence the force and flow of the blood. It is an important aspect of patients care in operating rooms and critical care units. It aims to guide medical management so as to prevent or treat organ failure and improve the outcomes of patients.
Detailed description
Hemodynamic monitoring is measuring and monitoring the factors that influence the force and flow of the blood. It is an important aspect of patients care in operating rooms and critical care units. It aims to guide medical management so as to prevent or treat organ failure and improve the outcomes of patients. This monitoring itself includes several different techniques and may range from invasive to less and even non-invasive techniques.
Critically ill patients are often hemodynamically unstable (or at risk of becoming unstable) owing to hypervolemia, cardiac dysfunction or alterations of vasomotor function, leading to organ dysfunction, deterioration into multi-organ failure and eventually death range from 15% to 25% of patients admitted to intensive care units.
Impedance cardiography (ICG) and Electrical Cardiometry (EC) are recently developed technologies to measure thoracic fluid content (TFC), cardiac output (CO) and other hemodynamic parameters. Both ICG and EC derive CO from measurements of Thoracic Electrical Bioimpedance (TEB).
One of the parameters examined by electrical cardiometry is thoracic fluid content(TFC) ,which is inversely associated with the patient's transthoracic electrical bioimpedance, and reflects the total (intravascular and extravascular) fluid volume contained in the chest cavity. A study concluded that electrical cardiometry monitoring indicated new possibility to anticipate prognosis of pneumonia patient. Increased thoracic fluid content value would relate to worse outcome of the patient like mortality and intensive care unit admission. Electrical cardiometry monitoring allows real-time measurements of thoracic fluid content without restraining the patient or invasive catheters.
In ARDS patients with cardiac comorbidities, TFC can distinguish between non-cardiogenic and cardiogenic pulmonary edema. In addition, TFC is helpful in the differential diagnosis of the mechanisms of respiratory failure. Thus, recently it was shown that TFC was greater in ARDS than in patients with atelectasis or pleural effusion. Therefore, depending on the TFC value, we can provide different therapeutic interventions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients indicated for admission to respiratory critical care unit of chest medicine department | – | Diagnostic Test: Hemodynamic parameters was measured by using electric cardiometry (ICON)130 patients >18 years old were enrolled during the period from December 2023 to December 2024 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Any Patient indicated for admission to respiratory critical care unit of chest medicine department at Mansoura University Hospitals whatever the indication was
Key inclusion criteria (2 listed)
- Age >18 years.
- Patients indicated for admission to respiratory critical care unit of chest medicine department at Mansoura University Hospitals whatever the indication was.
Key exclusion criteria (3 listed)
- Patients with malignancy either primary or metastatic lung cancer.
- Advanced chronic pulmonary fibrosis.
- Pleural and or pericardial effusions.
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 |
|---|---|---|
| Hemodynamic parameters was measured by using electric cardiometry (ICON)Hemodynamic parameters was measured daily at 10 a.m by using ICON non-invasive cardiometer model C3 made in Germany by OSYPKA medical (figure 5) by placing the four sensors on the neck and left side of the thorax allow for the continuous measurement of the changes of electrical conductivity within the thorax parameters such as CO, TFC, SVV and FTC were calculated 3 times with 5-min intervals and stored on the device automatically. | Diagnostic test | Patients indicated for admission to respiratory critical care unit of chest medicine department |
Primary outcome
length of respiratory intensive care unit stay
Time frame: 6 months
Thoracic fluid content as an outcome predictor in length of stay in respiratory intensive care unit
duration of invasive mechanical ventilation
Time frame: 6 months
Thoracic fluid content as an outcome predictor in duration of invasive mechanical ventilation
1 secondary outcome
mortality
Time frame: 12 months
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 Aug 2025.
- 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.
Mohamed AbdElmoniem principal investigator
Lecturer of chest medicine faculty of medicine Mansoura university
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 Diseases, run by Mansoura University Hospital 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 2 inclusion and 3 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 Aug 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?
length of respiratory intensive care unit stay (time frame: 6 months). The study lists 2 primary outcomes in all. 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 Aug 2025.