Effect of High-flow Nasal Oxygen on Extubation Outcome
1 other identifier
interventional
400
1 country
1
Brief Summary
The purpose of this study is to determine whether high flow nasal cannula is effective in lowering the reintubation rate after extubation for high risk patients in medical intensive care unit
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2014
CompletedFirst Posted
Study publicly available on registry
November 14, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedDecember 15, 2014
December 1, 2014
1.8 years
October 2, 2014
December 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
reintubation rate
72 hours after extubation
Secondary Outcomes (12)
Need for Non-Invasive Ventilation
at day 28 after inclusion in the study
ICU readmission rate due to respiratory failure
at day 28 after inclusion in the study
ICU mortality rate
at day 28 after inclusion in the study
ICU length of stay
at day 28 after inclusion in the study
Hospital mortality
at day 28 after inclusion in the study
- +7 more secondary outcomes
Study Arms (2)
high flow nasal cannula
EXPERIMENTALHigh flow nasal cannula immediately use after extubation
stanrd oxygen therapy
PLACEBO COMPARATOROxygen cannula or mask after extubation
Interventions
High flow nasal cannula used in postextubation patients
Eligibility Criteria
You may qualify if:
- Patients mechanically ventilated for \> 48 hours and at least one of the following:
- \> 65 y/o
- Cardiac failure as the primary indication of mechanical ventilation
- COPD
- Bronchiectasis
- Old pulmonary tuberculosis with destructive lung
- Chronic renal failure
- Neuromuscular disease
- BMI \> 30
- Inability to manage respiratory secretions
- ARDS
You may not qualify if:
- Presence of tracheostomy
- Recent facial trauma
- Active gastro-intestinal bleeding
- Planned NIPPV support after extubation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mackay Memorial Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kuo Li Kuo, MD
+886975835135 lmn4093@gmail.com
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2014
First Posted
November 14, 2014
Study Start
December 1, 2014
Primary Completion
September 1, 2016
Study Completion
October 1, 2016
Last Updated
December 15, 2014
Record last verified: 2014-12