Back to resultsThe Role of Muscular Ultrasound in Predicting Weaning Success
Primary Purpose
Respiratory Insufficiency
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Muscular ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Respiratory Insufficiency focused on measuring Ultrasonography, Weaning
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)
Sites / Locations
- Seoul National University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Muscular ultrasound
Arm Description
Outcomes
Primary Outcome Measures
Extubation success (no need for reintubation)
Secondary Outcome Measures
Weaning success (no need for applying the ventilator again)
Full Information
NCT ID
NCT02864459
First Posted
August 7, 2016
Last Updated
August 18, 2021
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02864459
Brief Title
The Role of Muscular Ultrasound in Predicting Weaning Success
Official Title
The Role of Muscular Ultrasound in Predicting Weaning Success
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
Keywords
Ultrasonography, Weaning
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
114 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Muscular ultrasound
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Muscular ultrasound
Intervention Description
Muscular ultrasound is done before extubation
Primary Outcome Measure Information:
Title
Extubation success (no need for reintubation)
Time Frame
48 hours after extubation
Secondary Outcome Measure Information:
Title
Weaning success (no need for applying the ventilator again)
Time Frame
2 hours after spontaneous breathing trial
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Seoul National University
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Role of Muscular Ultrasound in Predicting Weaning Success
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