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

NCT03942055 | Withdrawn DMC FDA Device

• 1 other identifier: F34567890
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Edema

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Sonosite Edge II Ultrasound DEVICE

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

B-line score <7; B-line score ≥7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Related Publications (2)

• 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.

  PMID: 29172943 RESULT

• 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.

  PMID: 29174750 RESULT

MeSH Terms

Conditions

Pulmonary Edema

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ahmed Zaky, MD MPH FCCM

  UAB Department of Anesthesiology, Critical Care Division

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 8, 2019
• Study Start: October 15, 2018
• Primary Completion: December 1, 2018
• Study Completion: March 15, 2019
• Last Updated: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share