Clinical Trials Directory

Trials / Unknown

UnknownNCT03171935

Wean Early With HFNCO vs NPPV in Patients With AHRF

Wean Early With High-Flow Nasal Cannula Oxygenation Versus Noninvasive Positive Pressure Ventilation in Patients With Acute Hypoxemic Respiratory Failure: a Multicenter, Randomized, Controlled Trial (the WHEN Study)

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
270 (estimated)
Sponsor
Beijing Chao Yang Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The main purpose of the present study is to verify whether, as compared with conventional weaning, early weaning with high-flow nasal cannula oxygenation or noninvasive positive pressure ventilation may more effective in shortening the duration of invasive ventilation, hence reducing the rates of complications and mortality in patients with acute hypoxemic respiratory failure.

Conditions

Interventions

TypeNameDescription
DEVICEHigh-Flow Nasal Cannula OxygenationHigh-flow nasal cannula oxygenation will be applied immediately after early extubation, with a gas flow rate of 50 liters per minute and a fraction of inspired oxygen of 1.0 at initiation. The fraction of inspired oxygen will be subsequently adjusted to maintain a peripheral oxygen saturation of 92% or more.
DEVICENoninvasive Positive Pressure VentilationNoninvasive positive pressure ventilation will be applied immediately after early extubation, with a noninvasive ventilator (Respironics V60, Philips) using the NIPSV mode at initiation. The fraction of inspired oxygen will be adjusted to achieve SpO2 \>92% with an initial expiratory positive airway pressure (EPAP) of 4 cmH2O. EPAP will be increased gradually in increments of 1-2 cmH2O, up to a maximum of 12 cmH2O, to achieve SpO2 \>96%. Inspiratory positive airway pressure (IPAP) will be initially set at 8 cmH2O and be increased gradually in increments of 1-2 cmH2O according to patients' tolerance to obtain a tidal volume (VT) of 6-8 mL/kg.
DEVICEConventional weaningThe patients will undergo conventional weaning protocol. Extubation and subsequent oxygen therapy with venturi mask will be performed after successful spontaneous trial.

Timeline

Start date
2017-06-01
Primary completion
2021-12-31
Completion
2022-03-31
First posted
2017-05-31
Last updated
2021-07-02

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03171935. Inclusion in this directory is not an endorsement.