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Effect of High-flow Nasal Oxygen on Extubation Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02290548
Recruitment Status : Unknown
Verified December 2014 by Mackay Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : November 14, 2014
Last Update Posted : December 15, 2014
Sponsor:
Information provided by (Responsible Party):
Mackay Memorial Hospital

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

Condition or disease Intervention/treatment Phase
Respiratory Failure Congestive Heart Failure COPD Device: high flow nasal cannula Not Applicable

Detailed Description:
The study hypothesis is that Optiflow may reduce the extubation failure rate for high risk patients in medical intensive care unit.In the intervention group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive high-flow nasal cannula (Optiflow Airvo2, Fisher & Paykel Healthcare Ltd., New Zealand) after extubation. The oxygen concentration (FiO2) will be set to reach an oxygenation target similar to control patients (see below), while the gas flow rate will be set at 50 L/min.In the control group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive standard oxygen therapy including nasal cannula or oxygen mask after extubation. The FiO2 will be set to obtain a arterial oxygen saturation (SpO2) between 92% and 98% (or between 88% and 95% in hypercapnic patients). NIPPV or intubation will be applied in both group if respiratory distress noted. High flow nasal cannula will be tried before NIPPV or intubation in the control group patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of High-flow Nasal Oxygen vs Standard Oxygen Therapy on Extubation Outcome With High Risk of Extubation Failure in Medical ICU Patients
Study Start Date : December 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: high flow nasal cannula
High flow nasal cannula immediately use after extubation
Device: high flow nasal cannula
High flow nasal cannula used in postextubation patients
Other Name: Optiflow Airvo2 (Fisher & Paykel Healthcare)

Placebo Comparator: stanrd oxygen therapy
Oxygen cannula or mask after extubation
Device: high flow nasal cannula
High flow nasal cannula used in postextubation patients
Other Name: Optiflow Airvo2 (Fisher & Paykel Healthcare)




Primary Outcome Measures :
  1. reintubation rate [ Time Frame: 72 hours after extubation ]

Secondary Outcome Measures :
  1. Need for Non-Invasive Ventilation [ Time Frame: at day 28 after inclusion in the study ]
  2. ICU readmission rate due to respiratory failure [ Time Frame: at day 28 after inclusion in the study ]
  3. ICU mortality rate [ Time Frame: at day 28 after inclusion in the study ]
  4. ICU length of stay [ Time Frame: at day 28 after inclusion in the study ]
  5. Hospital mortality [ Time Frame: at day 28 after inclusion in the study ]
  6. Hospital length of stay [ Time Frame: at day 28 after inclusion in the study ]
  7. Nosocomial pneumonia rate [ Time Frame: at day 28 after inclusion in the study ]
  8. Desaturation ( SaO2< 90%) [ Time Frame: 72 hours after extubation ]
  9. Severe hypoxemia (PaO2/Fraction of inspired O2 < 200) [ Time Frame: Time Frame: 72 hours after extubation ]
  10. hypercapnia (PaCO2 > 50) [ Time Frame: 72 hours after extubation ]
  11. respiratory acidosis (arterial pH < 7.30) [ Time Frame: 72 hours after extubation ]
  12. severe tachypnea (>40/min) [ Time Frame: 72 hours after extubation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Presence of tracheostomy
  • Recent facial trauma
  • Active gastro-intestinal bleeding
  • Planned NIPPV support after extubation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290548


Contacts
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Contact: Kuo li Kuo, MD +886975835135 lmn4093@gmail.com

Locations
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Taiwan
Mackay Memorial Hospital Recruiting
Taipei, Taiwan
Principal Investigator: Kuo Li Kuo, MD         
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
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Principal Investigator: Kuo Li Kuo, MD +886975835135 lmn4093@gmail.com
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Responsible Party: Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT02290548    
Other Study ID Numbers: 14MMHIS164
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: December 15, 2014
Last Verified: December 2014
Keywords provided by Mackay Memorial Hospital:
high flow nasal cannula
extubation failure
Additional relevant MeSH terms:
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Respiratory Insufficiency
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases