The Role of Muscular Ultrasound in Predicting Weaning Suc... | NCT02864459

Studies
The Role of Muscular Ultrasound in Predicting Weaning Success

NCT02864459

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Aug 24, 2021Actual

Enrollment

114Estimated

Phase

Not Applicable

Conditions

Respiratory Insufficiency

Interventions

Muscular ultrasound

Countries

South Korea

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

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Aug 7, 2016

First Submission Date that Met QC Criteria

Aug 10, 2016

First Posted Date

Aug 12, 2016Estimated

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

Aug 18, 2021

Last Update Posted Date

Aug 24, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jinwoo Lee, Associate professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

When attempting to wean a patient from the ventilator, even if he/she passes the spontaneous breathing test, 10-20% of the time extubation failure occurs and the patient is reintubated. When the patient is reintubated the mortality rate increases and the length of intensive care unit stay is also increased. It is vital to intensively assess the patient before extubation and correctly predict extubation success. Muscular ultrasound may be helpful in these situations.

Detailed Description

Not provided

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

114Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Muscular ultrasound	Experimental		Other: Muscular ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Muscular ultrasound	Other	Muscular ultrasound is done before extubation	Muscular ultrasound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Extubation success (no need for reintubation)		48 hours after extubation

Secondary Outcomes

Measure	Description	Time Frame
Weaning success (no need for applying the ventilator again)		2 hours after spontaneous breathing trial

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients undergoing weaning from mechanical ventilation
Patients who have been mechanically ventilated for more than 72 hrs

Exclusion Criteria:

Pregnant patients
Patients with previous neuromuscular diseases
Difficulties in muscular ultrasound (Dressing, operation, etc)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided