Effect of High-flow Nasal Oxygen on Extubation Outcome

Mackay Memorial Hospital

Status: Unknown

Conditions: Respiratory Failure; COPD; Congestive Heart Failure

Treatments: Device: high flow nasal cannula

Study type: Interventional

Funder types: Other

Identifiers

NCT02290548

14MMHIS164

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups, including a placebo group

high flow nasal cannula

Experimental group

Description:

High flow nasal cannula immediately use after extubation

Treatment:

Device: high flow nasal cannula

stanrd oxygen therapy

Placebo Comparator group

Description:

Oxygen cannula or mask after extubation

Treatment:

Device: high flow nasal cannula