Thoracic Ultrasonography for Pulmonary Edema in Patients With Pre-Eclampsia

Pre-eclampsia Clinical Trial

Official title:

Thoracic Ultrasonography for the Assessment of Pulmonary Edema in Patients With Pre-Eclampsia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02357264
• Other study ID #: 2014-11-25
• Status: Recruiting
• Phase: N/A
• First received: January 31, 2015
• Last updated: September 5, 2016
• Start date: February 2015
• Est. completion date: June 2017

Study information

• Verified date: September 2016
• Source: Maimonides Medical Center
• Contact: Antonios Likourezos, MA, MPH
• Phone: 718-283-6896
• Email: alikourezos[@]maimonidesmed.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia
• Pulmonary Edema

Intervention

Device:
• Ultrasound
Ultrasound of the chest for the detection of fluid in the lung

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Antonios Likourezos

Country where clinical trial is conducted

United States, 

References & Publications (8)

Bamfo JE, Kametas NA, Nicolaides KH, Chambers JB. Maternal left ventricular diastolic and systolic long-axis function during normal pregnancy. Eur J Echocardiogr. 2007 Oct;8(5):360-8. Epub 2007 Feb 23. — View Citation

Dennis AT, Solnordal CB. Acute pulmonary oedema in pregnant women. Anaesthesia. 2012 Jun;67(6):646-59. doi: 10.1111/j.1365-2044.2012.07055.x. Epub 2012 Mar 15. Review. — View Citation

Hutcheon JA, Lisonkova S, Joseph KS. Epidemiology of pre-eclampsia and the other hypertensive disorders of pregnancy. Best Pract Res Clin Obstet Gynaecol. 2011 Aug;25(4):391-403. doi: 10.1016/j.bpobgyn.2011.01.006. Epub 2011 Feb 18. Review. — View Citation

Lichtenstein D, Goldstein I, Mourgeon E, Cluzel P, Grenier P, Rouby JJ. Comparative diagnostic performances of auscultation, chest radiography, and lung ultrasonography in acute respiratory distress syndrome. Anesthesiology. 2004 Jan;100(1):9-15. — View Citation

Lichtenstein D, Mézière G, Biderman P, Gepner A, Barré O. The comet-tail artifact. An ultrasound sign of alveolar-interstitial syndrome. Am J Respir Crit Care Med. 1997 Nov;156(5):1640-6. — View Citation

Sciscione AC, Ivester T, Largoza M, Manley J, Shlossman P, Colmorgen GH. Acute pulmonary edema in pregnancy. Obstet Gynecol. 2003 Mar;101(3):511-5. — View Citation

Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6. Review. — View Citation

Young P, Johanson R. Haemodynamic, invasive and echocardiographic monitoring in the hypertensive parturient. Best Pract Res Clin Obstet Gynaecol. 2001 Aug;15(4):605-22. Review. Erratum in: Best Pract Res Clin Obstet Gynaecol 2001 Oct;15(5):817. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of fluid in the lungs	Detection of Fluid in the lungs	Baseline	No