The Association of B-7 Lung Ultrasound Pattern With the Development of Postoperative Pulmonary Edema

Pulmonary Edema Clinical Trial

Official title:

Prospective Observational Study: The Association of B-7 Lung Ultrasound Pattern With the Development of Postoperative Pulmonary Edema After Major Non-cardiac Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03942055
• Other study ID #: F34567890
• Status: Withdrawn
• Start date: October 15, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: May 2020
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this proposal is to conduct a randomized controlled study to examine the association between the increase in extravascular lung water as determined by lung ultrasound and the development of radiologic pulmonary edema as diagnosed by chest roentgenogram in patients undergoing major elective open intra-peritoneal surgeries under general endotracheal anesthesia.

Description:

This study will be conducted at the University of Alabama at Birmingham's post- anesthesia care unit (PACU). A total of 60 patients will be randomly selected from the 5th and 7th floor surgical suite daily display boards and enrolled in the study. A preoperative and postoperative Point of Care (POCUS) lung U/S exam and Point of Care (POCUS) transthoracic echo will be performed with a Sonosite Edge II bedside U/S machine (approved by UAB Biomedical and Clinical Engineering Dept-#9365) in the pre-anesthesia holding area before the surgical procedure, and after the end of the procedure in the post- anesthesia care unit (PACU). EVLW will be defined as B-line score ≥7 before and after the surgical procedure. Pulmonary edema will be defined by the official radiology report on a chest X ray in the first 72 hrs postoperatively. Pre and Post Op POCUS Pulmonary Capillary Wedge Pressure (PCWP) will be obtained via Trans-thoracic bedside Ultrasound measuring Mitral Valve Inflow (E) Velocity and Early Diastolic Lateral Mitral Annulus Velocity/Tissue Doppler Imaging (E'). A 5-1Mhz Phased Array Probe will be used to obtain images. The PCWP data obtained will be used to correlate with EVLW findings. Ultrasound windows for PCWP measurements will be obtained using the Apical 4-chamber View and/or modified Subcostal View.-

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 15, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients = 18 years of age, undergoing major elective intraperitoneal surgeries expected to be in hospital for 72 hours

Exclusion Criteria:

• Patients < 18 years

• Pregnant females

• Cardiac EF 40% on last pre-operative echo

• Prisoners

Related Conditions & MeSH terms

• Edema
• Pulmonary Edema

Intervention

Device:
• Sonosite Edge II Ultrasound
Certified by UAB Biomedical and Clinical Engineering Dept- certification #9365 Mechanism of Action: Point of Care Bedside Ultrasound

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

References & Publications (2)

Assaad S, Kratzert WB, Shelley B, Friedman MB, Perrino A Jr. Assessment of Pulmonary Edema: Principles and Practice. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):901-914. doi: 10.1053/j.jvca.2017.08.028. Epub 2017 Aug 19. Review. — View Citation

Jaffee W, Hodgins S, McGee WT. Tissue Edema, Fluid Balance, and Patient Outcomes in Severe Sepsis: An Organ Systems Review. J Intensive Care Med. 2018 Sep;33(9):502-509. doi: 10.1177/0885066617742832. Epub 2017 Nov 26. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Pulmonary Edema	The development of newly onset pulmonary edema as diagnosed by chest X ray in the first 72 hrs post-operatively.	72 hours after the surgical procedure