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Effect of High-flow Nasal Oxygen on Extubation Outcome

NCT ID: NCT02290548

Last Updated: 2014-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Respiratory Failure Congestive Heart Failure COPD

Keywords

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high flow nasal cannula extubation failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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high flow nasal cannula

High flow nasal cannula immediately use after extubation

Group Type EXPERIMENTAL

high flow nasal cannula

Intervention Type DEVICE

High flow nasal cannula used in postextubation patients

stanrd oxygen therapy

Oxygen cannula or mask after extubation

Group Type PLACEBO_COMPARATOR

high flow nasal cannula

Intervention Type DEVICE

High flow nasal cannula used in postextubation patients

Interventions

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high flow nasal cannula

High flow nasal cannula used in postextubation patients

Intervention Type DEVICE

Other Intervention Names

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Optiflow Airvo2 (Fisher & Paykel Healthcare)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mackay Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kuo Li Kuo, MD

Role: PRINCIPAL_INVESTIGATOR

+886975835135 [email protected]

Locations

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Mackay Memorial Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Kuo li Kuo, MD

Role: CONTACT

Phone: +886975835135

Email: [email protected]

Other Identifiers

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14MMHIS164

Identifier Type: -

Identifier Source: org_study_id