NCT02864459

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

6.3 years

First QC Date

August 7, 2016

Last Update Submit

August 18, 2021

Conditions

Respiratory Insufficiency

Keywords

UltrasonographyWeaning

Outcome Measures

Primary Outcomes (1)

  • Extubation success (no need for reintubation)

    48 hours after extubation

Secondary Outcomes (1)

  • Weaning success (no need for applying the ventilator again)

    2 hours after spontaneous breathing trial

Study Arms (1)

Muscular ultrasound

EXPERIMENTAL
Other: Muscular ultrasound

Interventions

Muscular ultrasoundOTHER

Muscular ultrasound is done before extubation

Muscular ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University

Seoul, South Korea

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 7, 2016

First Posted

August 12, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

August 24, 2021

Record last verified: 2021-08

Locations

KR(1)