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
| Type | Name | Description |
|---|---|---|
| DEVICE | High-Flow Nasal Cannula Oxygenation | High-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. |
| DEVICE | Noninvasive Positive Pressure Ventilation | Noninvasive 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. |
| DEVICE | Conventional weaning | The 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.