NCT05636631

Brief Summary

This study aim will be to assess the effectiveness of chest ultrasound as a diagnostic and differentiating modality in cases of pneumonia and lung congestion . It also evaluates chests sonography effectiveness in follow-up of patients with pneumonia and lung congestion .

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 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

November 1, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

December 5, 2022

Status Verified

December 1, 2022

Enrollment Period

2.1 years

First QC Date

November 4, 2022

Last Update Submit

December 1, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Diagnostic tool

    Diagnosis of pneumonia vs lung congestion by using chest ultrasound examination viewing A-lines, B-lines, pleural effusion presence \& its initial amount .

    Baseline

  • Follow up after initiation of treatment

    Follow up of findings of chest U.S on day 1 after initiating therapy using same parameters ( A-lines, B-lines, pleural effusion) on day 3 of hospital admission

    Baseline ( day 3 of hospital admission)

  • Follow up before assessing final outcome

    Follow up of findings of chest U.S on day 1 after initiating therapy using same parameters ( A-lines, B-lines, pleural effusion) on day 7 of hospital admission

    Baseline ( day 7 of hospital admission)

Secondary Outcomes (1)

  • morbidity & mortality

    baseline

Study Arms (2)

Patients with Pneumonia (1)

Patients presented with symptoms suggestive of pneumonia as fever, tachypnea, cough with sputum. These patients will receive IV fluids \& antibiotics with follow up of sepsis parameters

Device: Chest ultrasound

Patients with decongestive heart failure (2)

Patients presented with symptoms suggestive of acute congestive heart failure as dyspnea, orthopnea, bilateral lower limb edema. These patients will receive anti-failure treatment as diuretics, ACE inhibitors \& Beta blockers with follow up of resolving signs of decompensated heart failure

Device: Chest ultrasound

Interventions

chest ultrasound as a non invasive, low cost \& bedside device for differentiation \& follow up of lung congestion \& pneumonia

Patients with Pneumonia (1)Patients with decongestive heart failure (2)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

both genders adult (above age of 18 years) critically ill patients

You may qualify if:

  • Adult (above 18 years old)
  • Both genders
  • Patient with symptoms suggestive of pneumonia
  • Patient with symptoms suggestive of acute congestive heart failure
  • admitted to Critical care unit

You may not qualify if:

  • Patients with Renal induced lung congestion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nardin Aymn

Asyut, Asyut Governorate, 71511, Egypt

RECRUITING

Related Publications (2)

  • Volpicelli G, Cardinale L, Garofalo G, Veltri A. Usefulness of lung ultrasound in the bedside distinction between pulmonary edema and exacerbation of COPD. Emerg Radiol. 2008 May;15(3):145-51. doi: 10.1007/s10140-008-0701-x. Epub 2008 Jan 31.

    PMID: 18236088BACKGROUND
  • Lichtenstein DA. BLUE-protocol and FALLS-protocol: two applications of lung ultrasound in the critically ill. Chest. 2015 Jun;147(6):1659-1670. doi: 10.1378/chest.14-1313.

    PMID: 26033127BACKGROUND

MeSH Terms

Conditions

PneumoniaPulmonary Edema

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mahmoud Ashry, Professor

    Professor Faculty of Medicine, Assiut University

    STUDY DIRECTOR

Central Study Contacts

Nardin Aymn, resident

CONTACT

Alaa Ahmed, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 4, 2022

First Posted

December 5, 2022

Study Start

November 1, 2022

Primary Completion

November 30, 2024

Study Completion

July 31, 2025

Last Updated

December 5, 2022

Record last verified: 2022-12

Locations