Pulmonary EdemaNCT05095974
Predictors of Pulmonary Edema in Severe Preeclampsia
An observational study of Pulmonary Edema, run by Assiut University.
Trial summary
Pre-eclampsia is a multisystem major cardiovascular disease of pregnancy with hypertension its main clinical manifestation. Acute pulmonary edema, which signifies severe disease, is a leading cause of death in women with pre-eclampsia, and is a frequent cause for admission to an intensive care unit Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Edema
- What is being tested?
- ultrasonography, echocardiography and thoracic electrical bioimpedence
- Type of treatment
- Medical device
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2021to 1 Dec 2023
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: After obtaining approval from the Medical Research Ethics Committee Faculty of medicine, Assiut University, Assiut, Egypt, this study will be done in ICU in Assiut University Woman Health Hospital . Written informed consents will be obtained from all participants, after reading the patient information sheet and describing the procedure to the participants
Who may be able to join
- Pregnant women with one or more of the following:
- new-onset cerebral or visual disturbances
- thrombocytopenia (platelet count <100 000/mL)
- elevated liver enzymes (transaminases) to twice the normal upper limit;
- severe persistent pain in the right upper or middle upper abdomen that does not respond to medication and is not explained by another condition
- renal insufficiency (serum creatinine >97 μmol/L), or a doubling of serum creatinine concentration in the absence of other renal disease
- systolic blood pressure ≥160mmHg or diastolic blood pressure ≥110mmHg on more than one occasion at least 4 h apart while the patient is on bed rest (unless antihypertensive therapy had been initiated before this time).
Who cannot join
- Age below 18 yr
- SP during the postpartum period
- refusal to participate to the study.
- history of cardiac or respiratory disease
- patients with clinical manifestations of pulmonary edema
About this study
Official title: Echocardiography, Thoracic Fluid Content and Lung Ultrasound Monitoring as Predictors of Pulmonary Edema in Severe Preeclampsia
Pre-eclampsia is a multisystem major cardiovascular disease of pregnancy with hypertension its main clinical manifestation. Acute pulmonary edema, which signifies severe disease, is a leading cause of death in women with pre-eclampsia, and is a frequent cause for admission to an intensive care unit
Read the detailed description
Outside pregnancy, transthoracic cardiac ultrasound (echocardiography) and lung ultrasound have become important diagnostic and monitoring tools in critically ill patients. Echocardiography allows a rapid and non-invasive assessment of myocardial contractility and preload, and lung ultrasound can be used to determine the amount of extravascular lung water (EVLW).
In pregnancy, there is evidence of a good correlation between non-invasive hemodynamic monitoring by echocardiography and invasive monitoring using a pulmonary artery catheter. Previous studies have shown that invasive hemodynamic monitoring could facilitate fluid management in patients with PE. However, recent studies have examined the utility of echocardiography in combination with lung ultrasound for guiding fluid therapy in patients with severe PE.
Thoracic fluid content (TFC) is one of the many variables measured by the ICON electrical cardiometry (EC) device (Osypka Medical, etc.). The ICON device is one relatively new proprietary implementation of impedance cardiography technology, which is also often called "thoracic electrical bio-impedance". Impedance cardiography is based on measuring the changes in total resistance of the thorax to electric current. The impedance (Zo) 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 will cause short term changes in thoracic impedance. TFC is calculated as the reciprocal of the total thoracic impedance (1/ Zo) and is considered a numerical measure of total (intravascular and extravascular) thoracic fluid. Although TFC is a measure of both extra and intra-vascular thoracic fluid, the investigators hypothesized that it might provide an estimate of the increase in intrathoracic fluids such as to facilitate the risk of pulmonary edema.
- Conditions
- Pulmonary Edema
- Being tested
- ultrasonography, echocardiography, thoracic electrical bioimpedence
- Medical subject headings
- Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographyDevice
Ultrasound assessment will performed with parturient in the supine position using Mindray device (DC-N6, with a phased array transducer, model P4-2, 3-6 MHz). A C60x 5-2 MHz convex transducer will used for lung ultrasound (Mindray device (DC-N6, with a phased array transducer, model P4-2, 3-6 MHz).The Echo Comet Score (ECS) will obtained by the 28-rib interspaces technique dividing the chest wall in 12 areas on the left side (from the second to the fourth intercostal space) and 16 (from the second to the fifth intercostal space) on the right anterior and lateral hemithorax.
echocardiographyDevice
MHz cardiac transducer for echocardiography with two-dimensional, M-mode, color-flow, continuous, pulsed wave and tissue Doppler imaging.
thoracic electrical bioimpedenceDevice
Also called electrical cardiometry
EC ICONR monitor (Osypka Medical, Inc., La Jolla, California and Berlin) will be applied to the patients through four ECG electrodes. The electrodes will be placed over the bare skin of patients at the following sites: (1) on the left neck below the ear; (2) directly superior to the midpoint of the left clavicle; (3) along the left mid-axillary line at the level of the xiphoid process; (4) two-inches caudad from the third electrode.
| Study group | Role | What they receive |
|---|---|---|
| A (main group) | 29 Consecutive patients with a singleton pregnancy complicated by severe PE will be included in the study at hospital admission. Assessment will be done by lung ultrasound , echocardiography and thoracic bioimpedence device Receives: Device: ultrasonography; Device: echocardiography; Device: thoracic electrical bioimpedence | |
| B (control group) | 29 Consecutive healthy patients with a singleton pregnancy (control group) will be included in the study at hospital admission. Assessment will be done by lung ultrasound , echocardiography and thoracic bioimpedence device Receives: Device: ultrasonography; Device: echocardiography; Device: thoracic electrical bioimpedence |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of pulmonary edema
number of patients that will have pulmonary edema assessed by echo comet score by lung ultrasound (the sum of B-lines if yield more than 280 denoting extravascular fluid in the lung
Measured: 4 days
Secondary outcomes (2)
Echocardiography
the increase in left ventricular end-diastolic pressures measured by (E/E' ratio, E/A ratio) and left ventricular systolic function estimated by eyeball ejection fraction
Measured: 4 days
Thoracic fluid content
the increase in thoracic fluid content measured by thoracic electrical bio-impedance device
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start30 Oct 2021 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EdemaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmeen alaa-eldeen elmasry, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095974
- Sponsor's protocol ID
- pulmonary edema
- Status last verified
- Sep 2021
- First submitted
- 13 Sep 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiography, Thoracic Fluid Content and Lung Ultrasound Monitoring as Predictors of Pulmonary Edema in Severe Preeclampsia
- ClinicalTrials.gov ID
- NCT05095974
- Acronym / sponsor ID
- pulmonary edema
- Conditions
- Pulmonary Edema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Oct 2021 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 27 Oct 2021 (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.
Pre-eclampsia is a multisystem major cardiovascular disease of pregnancy with hypertension its main clinical manifestation. Acute pulmonary edema, which signifies severe disease, is a leading cause of death in women with pre-eclampsia, and is a frequent cause for admission to an intensive care unit
Detailed description
Outside pregnancy, transthoracic cardiac ultrasound (echocardiography) and lung ultrasound have become important diagnostic and monitoring tools in critically ill patients. Echocardiography allows a rapid and non-invasive assessment of myocardial contractility and preload, and lung ultrasound can be used to determine the amount of extravascular lung water (EVLW).
In pregnancy, there is evidence of a good correlation between non-invasive hemodynamic monitoring by echocardiography and invasive monitoring using a pulmonary artery catheter. Previous studies have shown that invasive hemodynamic monitoring could facilitate fluid management in patients with PE. However, recent studies have examined the utility of echocardiography in combination with lung ultrasound for guiding fluid therapy in patients with severe PE.
Thoracic fluid content (TFC) is one of the many variables measured by the ICON electrical cardiometry (EC) device (Osypka Medical, etc.). The ICON device is one relatively new proprietary implementation of impedance cardiography technology, which is also often called "thoracic electrical bio-impedance". Impedance cardiography is based on measuring the changes in total resistance of the thorax to electric current. The impedance (Zo) 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 will cause short term changes in thoracic impedance. TFC is calculated as the reciprocal of the total thoracic impedance (1/ Zo) and is considered a numerical measure of total (intravascular and extravascular) thoracic fluid. Although TFC is a measure of both extra and intra-vascular thoracic fluid, the investigators hypothesized that it might provide an estimate of the increase in intrathoracic fluids such as to facilitate the risk of pulmonary edema.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A (main group) | – | Device: ultrasonography, Device: echocardiography, Device: thoracic electrical bioimpedence29 Consecutive patients with a singleton pregnancy complicated by severe PE will be included in the study at hospital admission. Assessment will be done by lung ultrasound , echocardiography and thoracic bioimpedence device |
| B (control group) | – | Device: ultrasonography, Device: echocardiography, Device: thoracic electrical bioimpedence29 Consecutive healthy patients with a singleton pregnancy (control group) will be included in the study at hospital admission. Assessment will be done by lung ultrasound , echocardiography and thoracic bioimpedence device |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- After obtaining approval from the Medical Research Ethics Committee Faculty of medicine, Assiut University, Assiut, Egypt, this study will be done in ICU in Assiut University Woman Health Hospital . Written informed consents will be obtained from all participants, after reading the patient information sheet and describing the procedure to the participants
Key inclusion criteria (7 listed)
- new-onset cerebral or visual disturbances
- thrombocytopenia (platelet count <100 000/mL)
- elevated liver enzymes (transaminases) to twice the normal upper limit;
- severe persistent pain in the right upper or middle upper abdomen that does not respond to medication and is not explained by another condition
- renal insufficiency (serum creatinine >97 μmol/L), or a doubling of serum creatinine concentration in the absence of other renal disease
Key exclusion criteria (5 listed)
- Age below 18 yr
- SP during the postpartum period
- refusal to participate to the study.
- history of cardiac or respiratory disease
- patients with clinical manifestations of pulmonary edema
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 |
|---|---|---|
| ultrasonographyUltrasound assessment will performed with parturient in the supine position using Mindray device (DC-N6, with a phased array transducer, model P4-2, 3-6 MHz). A C60x 5-2 MHz convex transducer will used for lung ultrasound (Mindray device (DC-N6, with a phased array transducer, model P4-2, 3-6 MHz).The Echo Comet Score (ECS) will obtained by the 28-rib interspaces technique dividing the chest wall in 12 areas on the left side (from the second to the fourth intercostal space) and 16 (from the second to the fifth intercostal space) on the right anterior and lateral hemithorax. | Device | A (main group), B (control group) |
| echocardiographyMHz cardiac transducer for echocardiography with two-dimensional, M-mode, color-flow, continuous, pulsed wave and tissue Doppler imaging. | Device | A (main group), B (control group) |
| thoracic electrical bioimpedenceAlso: electrical cardiometryEC ICONR monitor (Osypka Medical, Inc., La Jolla, California and Berlin) will be applied to the patients through four ECG electrodes. The electrodes will be placed over the bare skin of patients at the following sites: (1) on the left neck below the ear; (2) directly superior to the midpoint of the left clavicle; (3) along the left mid-axillary line at the level of the xiphoid process; (4) two-inches caudad from the third electrode. | Device | A (main group), B (control group) |
Primary outcome
detection of pulmonary edema
Time frame: 4 days
number of patients that will have pulmonary edema assessed by echo comet score by lung ultrasound (the sum of B-lines if yield more than 280 denoting extravascular fluid in the lung
2 secondary outcomes
Echocardiography
Time frame: 4 days
Thoracic fluid content
Time frame: 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Edema, run by Assiut University.
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 7 inclusion and 5 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 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
detection of pulmonary edema (time frame: 4 days). 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 27 Oct 2021.