Lung Ultrasound Signs and Patterns in COVID-19 Pregnant Women

Covid19 Clinical Trial

— PINK-CO  

Official title:

Lung Ultrasound Signs and Patterns in COVID-19 Pregnant Women - "The PINK-CO Protocol"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04823234
• Other study ID #: CEUR-2021-223
• Status: Completed
• Start date: March 10, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: September 2021
• Source: Azienda Sanitaria-Universitaria Integrata di Udine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

SARS-CoV-2 impact on pregnant women is not well known yet. Some authors demonstrated that lung ultrasound can give similar results if compared to chest computed tomography and better results if compared to chest x-rays without radiations and limited risks for mother and fetus.

The Lung Ultrasound Score (LUS) can be used to asses the entity and monitor the evolution of lung impairment.

Some authors described an artifact, the "light beam", as a typical ultrasound sign in COVID-19 positive patients.

With our study we hypothesize to understand the prevalence of this sign and other ultrasound signs in pregnant COVID-19 positive patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 15, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• All pregnant COVID 19 positive patients admitted at our institution who had lung ultrasound performed

Exclusion Criteria:

• are < 18 years old

• history of rheumatic disease

• history of spontaneous pneumothorax

• fibrothorax

• history of thoracic surgery

• no consent given

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Pregnancy Complications

Intervention

Diagnostic Test:
• Lung ultrasound
Lung ultrasound signs in Covid 19 positive pregnant patients

Locations

Country	Name	City	State
Italy	Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD	Udine

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria-Universitaria Integrata di Udine

Country where clinical trial is conducted

Italy, 

References & Publications (7)

Bouhemad B, Mongodi S, Via G, Rouquette I. Ultrasound for "lung monitoring" of ventilated patients. Anesthesiology. 2015 Feb;122(2):437-47. doi: 10.1097/ALN.0000000000000558. Review. — View Citation

Convissar DL, Gibson LE, Berra L, Bittner EA, Chang MG. Application of Lung Ultrasound During the COVID-19 Pandemic: A Narrative Review. Anesth Analg. 2020 Aug;131(2):345-350. doi: 10.1213/ANE.0000000000004929. Review. — View Citation

Li J, Long X, Wang X, Fang F, Lv X, Zhang D, Sun Y, Hu S, Lin Z, Xiong N. Radiology indispensable for tracking COVID-19. Diagn Interv Imaging. 2021 Feb;102(2):69-75. doi: 10.1016/j.diii.2020.11.008. Epub 2020 Nov 24. — View Citation

Lichtenstein D. Lung ultrasound in the critically ill. Curr Opin Crit Care. 2014 Jun;20(3):315-22. doi: 10.1097/MCC.0000000000000096. Review. — View Citation

Lichter Y, Topilsky Y, Taieb P, Banai A, Hochstadt A, Merdler I, Gal Oz A, Vine J, Goren O, Cohen B, Sapir O, Granot Y, Mann T, Friedman S, Angel Y, Adi N, Laufer-Perl M, Ingbir M, Arbel Y, Matot I, Szekely Y. Lung ultrasound predicts clinical course and outcomes in COVID-19 patients. Intensive Care Med. 2020 Oct;46(10):1873-1883. doi: 10.1007/s00134-020-06212-1. Epub 2020 Aug 28. Erratum in: Intensive Care Med. 2020 Sep 25;:. — View Citation

Rasmussen SA, Smulian JC, Lednicky JA, Wen TS, Jamieson DJ. Coronavirus Disease 2019 (COVID-19) and pregnancy: what obstetricians need to know. Am J Obstet Gynecol. 2020 May;222(5):415-426. doi: 10.1016/j.ajog.2020.02.017. Epub 2020 Feb 24. Review. — View Citation

Vetrugno L, Bove T, Orso D, Barbariol F, Bassi F, Boero E, Ferrari G, Kong R. Our Italian experience using lung ultrasound for identification, grading and serial follow-up of severity of lung involvement for management of patients with COVID-19. Echocardiography. 2020 Apr;37(4):625-627. doi: 10.1111/echo.14664. Epub 2020 Apr 15. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Light Beam	Evaluate the prevalence of the light beam sign	24 hours after admission
Secondary	Ultrasound patterns	Evaluate the prevalence of ultrasound signs and patterns during pregnancy	24 hours after admission
Secondary	Lung ultrasound score	Evaluate if the Lung ultrasound score relates with the clinical presentation of the patient	24 hours after admission
Secondary	Illness severity	Evaluate if the lung ultrasound score relates with the prognosis	24 hours after admission
Secondary	Length of stay	Evaluate if the lung ultrasound score relates with the length of stay	24 hours after admission