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Clinical Trials/NCT03942055
NCT03942055
Withdrawn
N/A

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

ConditionsPulmonary Edema

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pulmonary Edema
Sponsor
University of Alabama at Birmingham
Primary Endpoint
Incidence of Pulmonary Edema
Status
Withdrawn
Last Updated
5 years ago

Overview

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.-

Registry
clinicaltrials.gov
Start Date
October 15, 2018
End Date
March 15, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andrew Barker

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

Outcomes

Primary Outcomes

Incidence of Pulmonary Edema

Time Frame: 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.

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