The Role of Lung Ultrasound in The Diagnosis of Weaning -Induced Pulmonary Edema

The aim of the work is to

1. Assess the incidence of weaning induced pulmonary adema(WIPO).
2. Assess the risk factors of WIPO.
3. Evaluate the role of lung ultrasound in detecting WIPO during spontenous breathing trial(SBT).
4. Detect the threshold of B-line increase (Delta-B-lines) that provided the best diagnostic accuracy of WIPO.

Study Overview

• Status: Unknown
• Conditions: Detecting the Number of B-lines in Lung Ultrasound and Its Accuracy in Diagnosis of Weaning Induced Pulmonary Oedema
• Intervention / Treatment: Other: lung ultrasound

• Study Type: Observational
• Enrollment (Anticipated): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study will include patients on mechanical ventilation who will be suitable for spontaneous breathing trial (SBT).

Description

Inclusion Criteria:

• The study will include patients on mechanical ventilation who will be suitable for spontaneous breathing trial (SBT).

Exclusion Criteria:

• Patients with poor lung ultrasound window, history of cardiomyopathy, significant valvular disease (aortic or mitral insufficiency of grade ≥ 2, mild or severe aortic and mitral stenosis) will be excluded from the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group 1; patient who will develop weaning induced pulmonary adema	Other: lung ultrasound; patient with or without weaning induced pulmonary adema
group 2; patient who will nor develop weaning induced pulmonary adema	Other: lung ultrasound; patient with or without weaning induced pulmonary adema

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the number of B-lines in lung ultrasound and its accuracy in diagnosis of weaning induced pulmonary oedema	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: July 5, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease; Edema; Pulmonary Edema
• Other Study ID Numbers: LULTRASOUND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No