Pulmonary Edema Clinical Trial
Official title:
Evaluation of Lung Doppler Signals in Congestive Heart Failure(CHF)
The purpose of this study is to evaluate the lung Doppler signals in left HF patients with and without pulmonary congestion (i.e. decompensated left HF patients and compensated left HF patients respectively), in comparison to a control group of subjects without CHF (non-CHF controls), in order to determine the diagnostic value of this non-invasive method in CHF. If this method will prove to be of diagnostic value, it could potentially be used to diagnose and monitor CHF patients in both inpatient and outpatient settings.
Study Participants A total of 150 patients will be recruited for this study over a span of
18 months.
Patients will be divided into 3 subgroups:
1. Acute decompensated left heart failure- Patients are eligible for enrollment if they
presented to the emergency department within the previous few hours with acute
pulmonary congestion or pulmonary edema, diagnosed on the basis of all of the following
criteria:
1. Dyspnea at rest or with minimal activity
2. Rales on auscultation
3. Evidence of pulmonary congestion or edema on chest X-ray.
4. BNP level >400 pg/ml This subgroup will be recruited in the emergency medicine
department (EMD) following initial treatment and stabilization.
2. Compensated left heart failure - Patients with significant stable left HF (NYHA II-III)
who are on optimal medical treatment for CHF and are without clinical or laboratory
evidence of pulmonary congestion (i.e. patients without dyspnea at rest, without rales
on auscultation and with BNP levels < 100 pg/ml). This subgroup will be recruited among
inpatients and/or outpatients at the Rambam campus.
3. Non-CHF controls (patients without CHF and without uncontrolled hypertension). This
subgroup will be recruited among inpatients and/or outpatients at the Rambam health
care campus.
Study measurements
For the compensated left HF patients and the non-CHF controls, measurements will be done
once following inclusion.
For the decompensated left HF patients, several measurements will be conducted, both
following inclusion (at the EMD) and each day during hospitalization (at the internal
medicine department).
Measurements following inclusion:
Following informed consent and applying the inclusion and exclusion criteria, all eligible
patients will undergo physical examination including weight, vital signs (blood pressure,
heart rate, respiratory rate, O2 saturation by pulse oximetry) and a full assessment of CHF
status by physical examination (lung auscultation, assessment of leg edema, weight, JVP
etc.). (See figure 2). An ECG recording will be performed and a blood test for BNP will be
drawn for all patients.
For the assessment of dyspnea, decompensated left HF patients will be asked to indicate
their level of dyspnea on a visual analogue scale (3) and/or a 7-points categorical Likert
scale (4).
Chest X-ray: Decompensated patients will undergo chest X ray (CXR) as part of the regular
evaluation in the EMD. The 2 other subgroups will undergo CXR only if a recent CXR (<6
months) is not available, or if clinically indicated.
Echocardiography: an attempt will be made to perform echocardiography in the EMD for all
decompensated patients who are in sinus rhythm, including a full diastolic assessment.
However, due to the limited availability of the echocardiography service, not all patients
will undergo echo at the EMD and therefore this examination is considered optional.
A recent (<6 months) echocardiography is required for the 2 other subgroups. If a recent
echo is not available, a new one will be done as close as possible to inclusion.
Lung Doppler signals will be recorded in sitting position from selected locations over the
right chest wall. If the subject is unable to sit in a chair, the headrest of the patient's
bed will be tilted upwards to about 45 degrees. Regarding the decompensated left HF
patients, the first measurement of LDS will take place as soon as possible after admission
to the emergency medicine department, providing the patient has been adequately treated and
stabilized and is willing and able to sign an informed consent form. The LDS measurement
will be repeated twice more at the EMD at 1 hour intervals. LDS will be recorded only once
for the compensated patients and the non-CHF controls.
Follow up measurements during hospitalization (decompensated patients only) During their
hospital stay in the internal medicine department, decompensated left HF patients will
repeat part of the former study measurements.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02638649 -
Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
|
||
Completed |
NCT02232841 -
Electrical Impedance Imaging of Patients on Mechanical Ventilation
|
N/A | |
Completed |
NCT02105298 -
Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)
|
N/A | |
Withdrawn |
NCT04537975 -
C2Rx Hemofiltration Treatment in Severe or Critically Ill Adults With COVID-19
|
N/A | |
Recruiting |
NCT05276219 -
Optimized Treatment of Pulmonary Edema or Congestion
|
Phase 4 | |
Withdrawn |
NCT04508933 -
Comparison of Extra Vascular Lung Water Index in Covid-19 ARDS and "Typical"ARDS Patients
|
||
Recruiting |
NCT03728491 -
Education and Training Competences in Thoracic Ultrasound
|
N/A | |
Not yet recruiting |
NCT05095974 -
Predictors of Pulmonary Edema in Severe Preeclampsia
|
||
Recruiting |
NCT04115514 -
Treatment of ARDS With Instilled T3
|
Phase 2 | |
Withdrawn |
NCT01713595 -
Safety Study of Inhaled Saline in Acute Lung Injury
|
Phase 1 | |
Completed |
NCT00554580 -
Continuous Positive Airway Pressure for Acute Pulmonary Edema
|
Phase 3 | |
Withdrawn |
NCT03942055 -
The Association of B-7 Lung Ultrasound Pattern With the Development of Postoperative Pulmonary Edema
|
||
Active, not recruiting |
NCT03767803 -
Collection of Whole Blood Samples for the Evaluation of Preeclampsia (Pre-E) Biomarkers From Pregnant Women
|
||
Recruiting |
NCT05662995 -
Point-of-care Ultrasound Abnormalities in Early Onset Preeclampsia
|
N/A | |
Completed |
NCT00289276 -
FAST (Fluid Accumulation Status Trial)
|
N/A | |
Enrolling by invitation |
NCT06107465 -
High Versus Low Dose Nitroglycerin in Acute Pulmonary Edema
|
Phase 2/Phase 3 | |
Recruiting |
NCT05636631 -
Chest U/S in Differentiating Lung Congestion & Pneumonia in Adult Critically-ill Patients and Its Prognostic Impact
|
||
Not yet recruiting |
NCT05222711 -
The Use of a Monitoring Device by General Practitioners During Out-of-hours Care
|
N/A | |
Recruiting |
NCT02753023 -
Registry Of Acute meDical Emergencies in Brazil
|
||
Recruiting |
NCT01269177 -
Mortality and Risk Factors in Patients With Acute Cardiogenic Pulmonary Edema: a Multicentric, Observational, Prospective Study
|
N/A |