Clinical trial NCT05647967: Features of Regional Perfusion of Lung Consolidation
Official title: Evaluation of Regional Perfusion of Lung Consolidation Upon Lung Ultrasonography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Injury, Acute
Ultrasound Therapy; Complications
Keywords: lung consolidation, respiratory failure, perfusion
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: consolidation area index
timeFrame: through study completion, an average of 2 year
measure: blood flow score
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking union medical college hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Huaiwu He, MD
role: PRINCIPAL_INVESTIGATOR
References: