Features of Regional Perfusion of Lung Consolidation

Evaluation of Regional Perfusion of Lung Consolidation Upon Lung Ultrasonography

The aim of this study is to evaluate the potential usefulness of lung ultrasound to assess the size and perfusion of consolidation and explore their relationships with clinical outcome.

Study Overview

• Status: Recruiting
• Conditions: Ultrasound Therapy; Complications; Lung Injury, Acute
• Intervention / Treatment: Diagnostic test: Ultrasound

Detailed Description

Lung consolidation is one of the most causes of hypoxia in intensive care unit(ICU) settings. A quantitative measurement of consolidation would be extremely benefit for the clinical management in hypoxemia, both as an index of severity and to predict outcomes.In order to quantify the lung consolidation and its effect on clinical outcomes, a simple and quantitative scoring system of the size and perfusion of lung consolidation was proposed by lung ultrasound. Subjects with respiratory failure and lung consolidation proved by chest imaging underwent lung ultrasound examination. The size of consolidation and the richness of blood flow was computed upon lung ultrasound. The sensitivity, specificity and accuracy of the scoring system were calculated and compared to evaluate the diagnostic efficacy.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Na Wang, MD; Phone Number: 17810258960; Email: wangna_pumch2017@163.com
• Study Contact Backup: Name: Huaiwu He, MD; Phone Number: 010-69152300; Email: timuhhw@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100010
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Na Wang, MD; Phone Number: 17810258960; Email: wangna_pumch2017@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of adult(>18yr) patients admitted to the ICU. Patients presented with acute respiratory failure and pulmonary consolidation by chest imaging (lung ultrasound, X ray or CT scan) were eligible for inclusion. Acute respiratory failure was defined by at least one of the following criteria: PaO2/FiO2<300mmHg, breathing frequencies>30 breath/min, and could involve many potential causes of hypoxemia (e.g., sepsis, atelectasis, pneumonia, acute exacerbation of chronic lung disease).

Description

Inclusion criteria:

1. Admission to ICU( 18yr<age<90yr);
2. Patients presented with acute respiratory failure;
3. Pulmonary consolidation by chest imaging (lung ultrasound, X ray or CT scan).

Exclusion criteria:

1. Hemodynamic instability (i.e., severe hypotension with systolic arterial pressure<60mmHg despite fluid expansion and vasoactive support; systolic arterial pressure>180mmHg; uncontrolled cardiac arrhythmias);
2. Severe thoracic trauma;
3. Coronavirus disease 2019;
4. Pulmonary artery hypertension and pregnancy.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
the consolidation perfusion/the consolidation size; Patients with respiratory failure and lung consolidation proved by chest imaging underwent lung ultrasound to evaluate the regional perfusion and the size of consolidation.	Diagnostic test: Ultrasound; Each patient underwent ultrasound after admission of ICU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
consolidation area index	The volume of consolidation was measured by consolidation area index (CAI) which is calculated from two-dimensional measures, namely the product of the core distance (from the bottom to the top of the screen) and the longitudinal distance (from the left to the right of the screen).	through study completion, an average of 2 year
blood flow score	A semi-quantified scoring system based on the richness of flow signals was established. It identifies four progressive steps of blood signals, each corresponding to a score: no pulsatile blood flow-score 0; sparse dot-like blood flow-score 1; pronounced curvilinear vascularity-score 2; tree-like vascularity-score 3.	through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Huaiwu He, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Estimate): December 13, 2022

Study Record Updates

• Last Update Posted (Estimate): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: lung consolidation, respiratory failure, perfusion
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: I-22PJ140

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No