Thoracic Ultrasonography for Pulmonary Edema in Patients With Pre-Eclampsia
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | February 2015 |
| End Date: | June 2016 |
| Contact: | Antonios Likourezos, MA, MPH |
| Email: | alikourezos@maimonidesmed.org |
| Phone: | 718-283-6896 |
Thoracic Ultrasonography for the Assessment of Pulmonary Edema in Patients With Pre-Eclampsia
This project will study the use of ultrasound of the chest for the detection of fluid in the
lungs in patients with pre-eclampsia vs pregnant patients without pre-eclampsia.
Pre-eclampsia is a syndrome usually diagnosed in the second half of pregnancy in which
patients develop elevated blood pressure and may develop protein in their urine, neurologic
abnormalities, fluid in the lungs, and abnormal blood tests associated with the liver and
kidney. Pulmonary edema (fluid in the lungs) in pre-eclampsia can lead to patient discomfort
and significant morbidity and mortality. It can be detected using chest x-ray, although this
type of imaging offers significant disadvantages, including radiation, which is of
particular concern in pregnant patients. In addition, previous studies have demonstrated
that chest x-ray is not very accurate in the detection of fluid in the lungs. Multiple
previous studies have demonstrated the utility of chest ultrasonography in detecting fluid
in the chest, although the vast majority of these studies involved patients with acute
decompensated heart failure. Our goal is to evaluate bedside ultrasound of the chest in
patients with pre-eclampsia in comparison to normal pregnant patients to determine whether
these patients have abnormal fluid in the chest.
The investigators will divide our patients into two groups. In the study group, the
investigators will include patients with pre-eclampsia with or without shortness of breath,
and in the control group, the investigators will include pregnant patients without
pre-eclampsia. Informed consent will be obtained from all patients enrolled in the study.
These patients will then undergo an ultrasound of the chest, performed by a member of the
Emergency Medicine Ultrasound Division. The images will be transmitted wirelessly from the
ultrasound machine to a secure web based cloud (Q-path) and will be subsequently reviewed by
expert reviewers.
lungs in patients with pre-eclampsia vs pregnant patients without pre-eclampsia.
Pre-eclampsia is a syndrome usually diagnosed in the second half of pregnancy in which
patients develop elevated blood pressure and may develop protein in their urine, neurologic
abnormalities, fluid in the lungs, and abnormal blood tests associated with the liver and
kidney. Pulmonary edema (fluid in the lungs) in pre-eclampsia can lead to patient discomfort
and significant morbidity and mortality. It can be detected using chest x-ray, although this
type of imaging offers significant disadvantages, including radiation, which is of
particular concern in pregnant patients. In addition, previous studies have demonstrated
that chest x-ray is not very accurate in the detection of fluid in the lungs. Multiple
previous studies have demonstrated the utility of chest ultrasonography in detecting fluid
in the chest, although the vast majority of these studies involved patients with acute
decompensated heart failure. Our goal is to evaluate bedside ultrasound of the chest in
patients with pre-eclampsia in comparison to normal pregnant patients to determine whether
these patients have abnormal fluid in the chest.
The investigators will divide our patients into two groups. In the study group, the
investigators will include patients with pre-eclampsia with or without shortness of breath,
and in the control group, the investigators will include pregnant patients without
pre-eclampsia. Informed consent will be obtained from all patients enrolled in the study.
These patients will then undergo an ultrasound of the chest, performed by a member of the
Emergency Medicine Ultrasound Division. The images will be transmitted wirelessly from the
ultrasound machine to a secure web based cloud (Q-path) and will be subsequently reviewed by
expert reviewers.
This project will compare the use of ultrasound of the chest for the detection of fluid in
the lungs in patients with pre-eclampsia vs pregnant patients without pre-eclampsia.
Patients admitted to the obstetrical service will be recruited for study enrollment. We will
divide our patients into two groups. In the study group, we will include patients with
pre-eclampsia with or without shortness of breath, and in the control group, we will include
otherwise healthy pregnant patients. We will exclude patients who are in labor or who are
undergoing induction. Informed consent will be obtained from all patients enrolled in the
study.
Study subjects will then undergo an ultrasound of the chest, performed by a member of the
Emergency Medicine Ultrasound Division, who have experience in performing lung ultrasounds.
Both hemithoraces will be divided into 4 zones: anterior inferior, anterior superior,
lateral inferior, and lateral superior. Each zone will be assessed for the presence of
B-lines. For a zone to be considered "positive" for pulmonary edema, there should to be a
minimum of 3 B-lines. To diagnose a patient with pulmonary edema, at least two zones in both
hemithoraces must be positive. The study investigator will document the presence of B-lines
in each particular zone on the data collection sheet. Brief representative video clips will
be recorded for each zone.
After completing the sonographic examination, the images will be transmitted wirelessly from
the ultrasound machine to a secure web based cloud (Q-path) and will be subsequently
interpreted by expert reviewers who will be blinded to any clinical information about the
patient. They will also document their findings on a separate data collection sheet.
the lungs in patients with pre-eclampsia vs pregnant patients without pre-eclampsia.
Patients admitted to the obstetrical service will be recruited for study enrollment. We will
divide our patients into two groups. In the study group, we will include patients with
pre-eclampsia with or without shortness of breath, and in the control group, we will include
otherwise healthy pregnant patients. We will exclude patients who are in labor or who are
undergoing induction. Informed consent will be obtained from all patients enrolled in the
study.
Study subjects will then undergo an ultrasound of the chest, performed by a member of the
Emergency Medicine Ultrasound Division, who have experience in performing lung ultrasounds.
Both hemithoraces will be divided into 4 zones: anterior inferior, anterior superior,
lateral inferior, and lateral superior. Each zone will be assessed for the presence of
B-lines. For a zone to be considered "positive" for pulmonary edema, there should to be a
minimum of 3 B-lines. To diagnose a patient with pulmonary edema, at least two zones in both
hemithoraces must be positive. The study investigator will document the presence of B-lines
in each particular zone on the data collection sheet. Brief representative video clips will
be recorded for each zone.
After completing the sonographic examination, the images will be transmitted wirelessly from
the ultrasound machine to a secure web based cloud (Q-path) and will be subsequently
interpreted by expert reviewers who will be blinded to any clinical information about the
patient. They will also document their findings on a separate data collection sheet.
Inclusion Criteria:
- Age 18+ years of age
- Met criteria for pre-eclampsia as per ACOG guidelines for the study group
- Consent to participate in study
- Single intrauterine pregnancy
Exclusion Criteria:
1. Other cardiovascular or pulmonary problems
2. Other obstetrical or uteroplacental problems - abruption placenta, coagulopathy,
immunological disorders.
3. Patients who are in labor or are received induction medications such as Pitocin.
We found this trial at
1
site
4802 10th Ave
Brooklyn, New York 11219
Brooklyn, New York 11219
(718) 283-6000
Principal Investigator: Eitan Dickman, MD
Phone: 718-283-6896
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