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

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.

Study Overview

• Status: Withdrawn
• Conditions: Pulmonary Edema
• Intervention / Treatment: Device: Sonosite Edge II Ultrasound

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.-

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be enrolled in a sequential manner from the Kirklin Clinic Pre-operative Anesthesia clinic.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
B-line score ≥7; Patients with B-line score ≥7 at the end of the surgical procedure. The Sonosite Edge II Ultrasound device will be used. The B-line score will be partially based on the simplified 4-sector lung ultrasound scoring protocol used by Phillip Enghard at el. The Enghard study showed a closed correlation between the number of B-lines per intercostal space and EVLW Index measurements.	Device: Sonosite Edge II Ultrasound; Certified by UAB Biomedical and Clinical Engineering Dept- certification #9365 Mechanism of Action: Point of Care Bedside Ultrasound
B-line score <7; Patients with B-line score <7 at the end of the surgical procedure. The Sonosite Edge II Ultrasound device will be used. The B-line score will be partially based on the simplified 4-sector lung ultrasound scoring protocol used by Phillip Enghard at el. The Enghard study showed a closed correlation between the number of B-lines per intercostal space and EVLW Index measurements.	Device: Sonosite Edge II Ultrasound; Certified by UAB Biomedical and Clinical Engineering Dept- certification #9365 Mechanism of Action: Point of Care Bedside Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Study Chair: Ahmed Zaky, MD MPH FCCM, UAB Department of Anesthesiology, Critical Care Division

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 15, 2018
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): March 15, 2019

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (ACTUAL): May 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 8, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Edema; Pulmonary Edema
• Other Study ID Numbers: F34567890

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes