NCT05647967

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

December 13, 2022

Status Verified

November 1, 2022

Enrollment Period

2 years

First QC Date

November 29, 2022

Last Update Submit

December 8, 2022

Conditions

Keywords

lung consolidation, respiratory failure, perfusion

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

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

Interventions

UltrasoundDIAGNOSTIC_TEST

Each patient underwent ultrasound after admission of ICU.

the consolidation perfusion/the consolidation size

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking union medical college hospital

Beijing, Beijing Municipality, 100010, China

RECRUITING

Related Publications (1)

  • Wang N, Chi Y, Wang Q, Long Y, Liu D, Zhao Z, He H. Relationship between lung consolidation size measured by ultrasound and outcome in ICU patients with respiratory failure. BMC Pulm Med. 2025 Feb 26;25(1):91. doi: 10.1186/s12890-025-03564-6.

MeSH Terms

Conditions

Acute Lung InjuryRespiratory Insufficiency

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Huaiwu He, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2022

First Posted

December 13, 2022

Study Start

January 1, 2022

Primary Completion

December 31, 2023

Study Completion

January 31, 2024

Last Updated

December 13, 2022

Record last verified: 2022-11

Locations