Effect of High-flow Nasal Oxygen on Extubation Outcome

Not Applicable

• Conditions: Respiratory Failure; COPD; Congestive Heart Failure
• Interventions: Device: high flow nasal cannula

• Registration Number: NCT02290548
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-11-11
• Study First Posted: 2014-11-14
• Status Verified: 2014-12
• Study Start: 2014-12
• Last Update Submitted: 2014-12-11
• Last Update Posted: 2014-12-15
• Primary Completion: 2016-09
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stanrd oxygen therapy	high flow nasal cannula	Oxygen cannula or mask after extubation
high flow nasal cannula	high flow nasal cannula	High flow nasal cannula immediately use after extubation

Primary Outcome Measures

Name	Time	Method
reintubation rate	72 hours after extubation

Secondary Outcome Measures

Name	Time	Method
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
Hospital length of stay	at day 28 after inclusion in the study
Nosocomial pneumonia rate	at day 28 after inclusion in the study
Desaturation ( SaO2< 90%)	72 hours after extubation
Severe hypoxemia (PaO2/Fraction of inspired O2 < 200)	Time Frame: 72 hours after extubation
hypercapnia (PaCO2 > 50)	72 hours after extubation
respiratory acidosis (arterial pH < 7.30)	72 hours after extubation
severe tachypnea (>40/min)	72 hours after extubation

Trial Locations

Locations (1)

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan