Features of Regional Perfusion of Lung Consolidation

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05647967
Collaborator
(none)
200
1
25
8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Regional Perfusion of Lung Consolidation Upon Lung Ultrasonography
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jan 31, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. consolidation area index [through study completion, an average of 2 year]

    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).

  2. blood flow score [through study completion, an average of 2 year]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking union medical college hospital Beijing Beijing China 100010

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT05647967
Other Study ID Numbers:
  • I-22PJ140
First Posted:
Dec 13, 2022
Last Update Posted:
Dec 13, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peking Union Medical College Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 13, 2022