Clinical trial NCT02290548: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Failure
Congestive Heart Failure
COPD
Keywords: high flow nasal cannula
extubation failure
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: reintubation rate
timeFrame: 72 hours after extubation
Secondary outcomes:
measure: Need for Non-Invasive Ventilation
timeFrame: at day 28 after inclusion in the study
measure: ICU readmission rate due to respiratory failure
timeFrame: at day 28 after inclusion in the study
measure: ICU mortality rate
timeFrame: at day 28 after inclusion in the study
measure: ICU length of stay
timeFrame: at day 28 after inclusion in the study
measure: Hospital mortality
timeFrame: at day 28 after inclusion in the study
measure: Hospital length of stay
timeFrame: at day 28 after inclusion in the study
measure: Nosocomial pneumonia rate
timeFrame: at day 28 after inclusion in the study
measure: Desaturation ( SaO2< 90%)
timeFrame: 72 hours after extubation
measure: Severe hypoxemia (PaO2/Fraction of inspired O2 < 200)
timeFrame: Time Frame: 72 hours after extubation
measure: hypercapnia (PaCO2 > 50)
timeFrame: 72 hours after extubation
measure: respiratory acidosis (arterial pH < 7.30)
timeFrame: 72 hours after extubation
measure: severe tachypnea (>40/min)
timeFrame: 72 hours after extubation
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
affiliation: +886975835135 lmn4093@gmail.com
name: Kuo Li Kuo, MD
role: PRINCIPAL_INVESTIGATOR
References: