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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Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03942055
Enrollment
0
Registered
2019-05-08
Start date
2018-10-15
Completion date
2019-03-15
Last updated
2020-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Edema

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.-

Interventions

DEVICESonosite Edge II Ultrasound

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

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Pulmonary Edema72 hours after the surgical procedureThe development of newly onset pulmonary edema as diagnosed by chest X ray in the first 72 hrs post-operatively.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026