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

Withdrawn

• Conditions: Pulmonary Edema
• Interventions: Device: Sonosite Edge II Ultrasound

• Registration Number: NCT03942055
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.-

Study Timeline

• Study Start: 2018-10-15
• Primary Completion: 2018-12-01
• Study Completion: 2019-03-15
• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-08
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-08
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

• Patients < 18 years
• Pregnant females
• Cardiac EF 40% on last pre-operative echo
• Prisoners

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
B-line score <7	Sonosite Edge II Ultrasound	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.
B-line score ≥7	Sonosite Edge II Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Pulmonary Edema	72 hours after the surgical procedure	The development of newly onset pulmonary edema as diagnosed by chest X ray in the first 72 hrs post-operatively.