Features of Regional Perfusion of Lung Consolidation

Ultrasound Therapy; Complications Clinical Trial

Official title:

Evaluation of Regional Perfusion of Lung Consolidation Upon Lung Ultrasonography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05647967
• Other study ID #: I-22PJ140
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: November 2022
• Source: Peking Union Medical College Hospital
• Contact: Na Wang, MD
• Phone: 17810258960
• Email: wangna_pumch2017[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury
• Lung Injury, Acute
• Ultrasound Therapy; Complications

Intervention

Diagnostic Test:
• Ultrasound
Each patient underwent ultrasound after admission of ICU.

Locations

Country	Name	City	State
China	Peking union medical college hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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