Effect of High-flow Nasal Oxygen on Extubation Outcome

December 11, 2014 updated by: Mackay Memorial Hospital

Effect of High-flow Nasal Oxygen vs Standard Oxygen Therapy on Extubation Outcome With High Risk of Extubation Failure in Medical ICU Patients

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Mackay Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Optiflow Airvo2 (Fisher & Paykel Healthcare)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
reintubation rate
Time Frame: 72 hours after extubation
72 hours after extubation

Secondary Outcome Measures

Outcome Measure
Time Frame
Need for Non-Invasive Ventilation
Time Frame: at day 28 after inclusion in the study
at day 28 after inclusion in the study
ICU readmission rate due to respiratory failure
Time Frame: at day 28 after inclusion in the study
at day 28 after inclusion in the study
ICU mortality rate
Time Frame: at day 28 after inclusion in the study
at day 28 after inclusion in the study
ICU length of stay
Time Frame: at day 28 after inclusion in the study
at day 28 after inclusion in the study
Hospital mortality
Time Frame: at day 28 after inclusion in the study
at day 28 after inclusion in the study
Hospital length of stay
Time Frame: at day 28 after inclusion in the study
at day 28 after inclusion in the study
Nosocomial pneumonia rate
Time Frame: at day 28 after inclusion in the study
at day 28 after inclusion in the study
Desaturation ( SaO2< 90%)
Time Frame: 72 hours after extubation
72 hours after extubation
Severe hypoxemia (PaO2/Fraction of inspired O2 < 200)
Time Frame: Time Frame: 72 hours after extubation
Time Frame: 72 hours after extubation
hypercapnia (PaCO2 > 50)
Time Frame: 72 hours after extubation
72 hours after extubation
respiratory acidosis (arterial pH < 7.30)
Time Frame: 72 hours after extubation
72 hours after extubation
severe tachypnea (>40/min)
Time Frame: 72 hours after extubation
72 hours after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mackay Memorial Hospital

Investigators

  • Principal Investigator: Kuo Li Kuo, MD, +886975835135 lmn4093@gmail.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (ANTICIPATED)

September 1, 2016

Study Completion (ANTICIPATED)

October 1, 2016

Study Registration Dates

First Submitted

October 2, 2014

First Submitted That Met QC Criteria

November 11, 2014

First Posted (ESTIMATE)

November 14, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

December 15, 2014

Last Update Submitted That Met QC Criteria

December 11, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14MMHIS164

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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