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Effect of High-flow Nasal Oxygen on Extubation Outcome

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02290548
Enrollment
400
Registered
2014-11-14
Start date
2014-12-31
Completion date
2016-10-31
Last updated
2014-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure, COPD, Respiratory Failure

Keywords

high flow nasal cannula, extubation failure

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.

Interventions

DEVICEhigh flow nasal cannula

High flow nasal cannula used in postextubation patients

Sponsors

Mackay Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
reintubation rate72 hours after extubation

Secondary

MeasureTime frame
ICU readmission rate due to respiratory failureat day 28 after inclusion in the study
ICU mortality rateat day 28 after inclusion in the study
ICU length of stayat day 28 after inclusion in the study
Hospital mortalityat day 28 after inclusion in the study
Hospital length of stayat day 28 after inclusion in the study
Need for Non-Invasive Ventilationat 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
Nosocomial pneumonia rateat day 28 after inclusion in the study

Countries

Taiwan

Contacts

Primary ContactKuo li Kuo, MD
lmn4093@gmail.com+886975835135

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026