NCT03942055

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

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.-

Conditions

• Pulmonary Edema

Interventions

Type	Name	Description
DEVICE	Sonosite Edge II Ultrasound	Certified by UAB Biomedical and Clinical Engineering Dept- certification #9365 Mechanism of Action: Point of Care Bedside Ultrasound

Timeline

• Start date: 2018-10-15
• Primary completion: 2018-12-01
• Completion: 2019-03-15
• First posted: 2019-05-08
• Last updated: 2020-05-12

Regulatory

• FDA-regulated device study