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Effect of High-flow Nasal Oxygen on Extubation Outcome

Primary Purpose

Respiratory Failure, Congestive Heart Failure, COPD

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
high flow nasal cannula
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring high flow nasal cannula, extubation failure

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mackay Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

high flow nasal cannula

stanrd oxygen therapy

Arm Description

High flow nasal cannula immediately use after extubation

Oxygen cannula or mask after extubation

Outcomes

Primary Outcome Measures

reintubation rate

Secondary Outcome Measures

Need for Non-Invasive Ventilation
ICU readmission rate due to respiratory failure
ICU mortality rate
ICU length of stay
Hospital mortality
Hospital length of stay
Nosocomial pneumonia rate
Desaturation ( SaO2< 90%)
Severe hypoxemia (PaO2/Fraction of inspired O2 < 200)
hypercapnia (PaCO2 > 50)
respiratory acidosis (arterial pH < 7.30)
severe tachypnea (>40/min)

Full Information

First Posted
October 2, 2014
Last Updated
December 11, 2014
Sponsor
Mackay Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02290548
Brief Title
Effect of High-flow Nasal Oxygen on Extubation Outcome
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 Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mackay Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Congestive Heart Failure, COPD
Keywords
high flow nasal cannula, extubation failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
high flow nasal cannula
Arm Type
Experimental
Arm Description
High flow nasal cannula immediately use after extubation
Arm Title
stanrd oxygen therapy
Arm Type
Placebo Comparator
Arm Description
Oxygen cannula or mask after extubation
Intervention Type
Device
Intervention Name(s)
high flow nasal cannula
Other Intervention Name(s)
Optiflow Airvo2 (Fisher & Paykel Healthcare)
Intervention Description
High flow nasal cannula used in postextubation patients
Primary Outcome Measure Information:
Title
reintubation rate
Time Frame
72 hours after extubation
Secondary Outcome Measure Information:
Title
Need for Non-Invasive Ventilation
Time Frame
at day 28 after inclusion in the study
Title
ICU readmission rate due to respiratory failure
Time Frame
at day 28 after inclusion in the study
Title
ICU mortality rate
Time Frame
at day 28 after inclusion in the study
Title
ICU length of stay
Time Frame
at day 28 after inclusion in the study
Title
Hospital mortality
Time Frame
at day 28 after inclusion in the study
Title
Hospital length of stay
Time Frame
at day 28 after inclusion in the study
Title
Nosocomial pneumonia rate
Time Frame
at day 28 after inclusion in the study
Title
Desaturation ( SaO2< 90%)
Time Frame
72 hours after extubation
Title
Severe hypoxemia (PaO2/Fraction of inspired O2 < 200)
Time Frame
Time Frame: 72 hours after extubation
Title
hypercapnia (PaCO2 > 50)
Time Frame
72 hours after extubation
Title
respiratory acidosis (arterial pH < 7.30)
Time Frame
72 hours after extubation
Title
severe tachypnea (>40/min)
Time Frame
72 hours after extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuo li Kuo, MD
Phone
+886975835135
Email
lmn4093@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuo Li Kuo, MD
Organizational Affiliation
+886975835135 lmn4093@gmail.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mackay Memorial Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuo Li Kuo, MD

12. IPD Sharing Statement

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Effect of High-flow Nasal Oxygen on Extubation Outcome

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