Validity of Lung Ultrasound in Diagnosis of Acute Respira... | NCT05886556

Studies
Validity of Lung Ultrasound in Diagnosis of Acute Respiratory Distress Syndrome

NCT05886556

Sponsor

Zagazig University

Status

Unknown status

Last Update Posted

Jun 26, 2023Actual

Enrollment

57Estimated

Phase

Not provided

Conditions

of Lung Ultrasound in Diagnosis of Acute Respiratory Distress Syndrome

Interventions

Not provided

Countries

Egypt

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

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Actual

Primary Completion Date

Sep 30, 2023Estimated

Completion Date

Dec 30, 2023Estimated

First Submitted Date

May 23, 2023

First Submission Date that Met QC Criteria

Jun 1, 2023

First Posted Date

Jun 2, 2023Actual

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

Jun 22, 2023

Last Update Posted Date

Jun 26, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marwa Mohamed Medhat, lecture of anesthesia and surgical intensive care (Principal Investigator), Zagazig UniversityPrincipal Investigator

Lead Sponsor

Zagazig UniversityOTHER_GOV

Collaborators

Not provided

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

To evaluate the validity of lung ultrasound compared to CT chest and chest radiograph for diagnosis of ARDS and prediction of successful weaning from mechanical ventilation in those patients compared to traditional methods.

Detailed Description

57 patients will be diagnosed as ARDS by CT chest and clinical criteria, then will be compared between the findings by lung ultrasound and chest radiograph to detect the sensitivity of both imaging to CT chest as gold standard in diagnosis of ARDS patients

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

57Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
diagnostic data checklist	Data of CT chest ,lung ultrasound and chest radiography in diagnosis of ARDS .	immediately after ICU admission

Secondary Outcomes

Measure	Description	Time Frame
success rate	compared the success of both methods in terms of reintubation or not for those patients	within 24 hours after weaning
lung ultrasound as a predictor for weaning	evaluate the scoring of lung aeration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients or legal guardian's consent .All patients with suspicious criteria of acute respiratory distress syndrome .Hemodynamically stable in the absence or minimal of vasopressors.

Exclusion Criteria:

Pregnant women. patients with traumatic lung injury or pneumothorax. surgical dressings over the right lower rib cage which would preclude ultrasound examination. presence of ascites. presence of lung collapse, fibrosis, or pleural effusion.

-presence of any mass or mechanical factor in the chest or the abdomen interfering with the diaphragmatic mobility.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

patients highly suspected to be ARDS admitted to ICU

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marwa M Medhat, M.D	Contact	0552330832		Medhatmarwa9@gmail.com

Overall Officials

Name	Affiliation	Role
mona elharisy, M.D	zagazig university faculty of human medicine	Study Director
Marwa M Medhat, M.D	zagazig university faculty of human medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine,Zagazig University	Recruiting	Zagazig	Sharqia Province	44519	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided