Lung Ultrasound Score and Weaning Outcome | NCT05289960

Studies
Lung Ultrasound Score and Weaning Outcome

NCT05289960

Sponsor

Cairo University

Status

Completed

Last Update Posted

Apr 1, 2022Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Lung Ultrasound Score
Acute Respiratory Failure

Interventions

lung ultrasound

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

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2020Actual

Primary Completion Date

Feb 28, 2022Actual

Completion Date

Mar 1, 2022Actual

First Submitted Date

Mar 2, 2022

First Submission Date that Met QC Criteria

Mar 11, 2022

First Posted Date

Mar 22, 2022Actual

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

Mar 21, 2022

Last Update Posted Date

Apr 1, 2022Actual

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

Objectives: Failure of extubation of patients on mechanical ventilation is one of the common problems in the ICU.

Aim of work: To evaluate the validity of lung ultrasound score in prediction of weaning outcomes and post-extubation distress.

Detailed Description

Methods: A prospective observational study of 50 patients planned for extubation who passed a spontaneous breathing trial, lung ultrasound score and serum level of NT-PRO BNP were done to all patients at end of spontaneous breathing trial, and all patients were followed after extubation and monitored for oxygenation, re-intubation rate, ICU stay, and ICU mortality.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients eligible for weaning by spontaneous breathing trial	Other		Other: lung ultrasound
non invasive ventilation after weaning	Other		Other: lung ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lung ultrasound	Other	Lung ultrasound score was done at the end of SBT using curved array ultrasound probe 2-5 MHz, Siemens X300, Korea	non invasive ventilation after weaning

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Extubation success	number of participants that do not need for respiratory support neither NIV nor intubation for one week during ICU stay	48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- 1. Patients age > 18 years

2. Patients intubated and mechanically ventilated for more than 48 hours in the intensive care unit and planned for extubation.

Exclusion Criteria:

1. Patients < or =18 years 2. Patients with left ventricular failure

3. Right ventricular failure

4. Pulmonary hypertension

5. Aortic valve disease

6. Hyperthyroidism

7. Tracheostomy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
farouk faris, MD	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo University Hospitals		Cairo		11345	Egypt