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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03942055

Recruitment Status Withdrawn (PI determined not enough clinical staff support for project.)

First Posted May 8, 2019

Last update posted May 12, 2020

Study Description

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.

  • Condition or Disease:Pulmonary Edema
  • Intervention/Treatment: Device: Sonosite Edge II Ultrasound
  • Phase: N/A
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 Design
  • Study Type: Observational
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Prospective Observational Study: The Association of B-7 Lung Ultrasound Pattern With the Development of Postoperative Pulmonary Edema After Major Non-cardiac Surgery
  • Estimated Study Start Date: October 2018
  • Estimated Primary Completion Date: December 2018
  • Estimated Study Completion Date: March 2019
Groups and Cohorts
Groups/Cohorts 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
Outcome Measures
  • Primary Outcome Measures: 1. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Patients will be enrolled in a sequential manner from the Kirklin Clinic Pre-operative Anesthesia clinic.
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

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

Study Chair: Ahmed Zaky, MD MPH FCCM UAB Department of Anesthesiology, Critical Care Division

More Information