The Role of Lung Ultrasound in The Diagnosis of Weaning -... | NCT04463303

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

NCT04463303

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jul 9, 2020Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Detecting the Number of B-lines in Lung Ultrasound and Its Accuracy in Diagnosis of Weaning Induced Pulmonary Oedema

Interventions

lung ultrasound

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2020Estimated

Primary Completion Date

Dec 2020Estimated

Completion Date

Jul 2021Estimated

First Submitted Date

Jul 5, 2020

First Submission Date that Met QC Criteria

Jul 8, 2020

First Posted Date

Jul 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2020

Last Update Posted Date

Jul 9, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the work is to

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group 1		patient who will develop weaning induced pulmonary adema	Other: lung ultrasound
group 2		patient who will nor develop weaning induced pulmonary adema	Other: lung ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lung ultrasound	Other	patient with or without weaning induced pulmonary adema	group 1 group 2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided