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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03171935
Enrollment
270
Registered
2017-05-31
Start date
2017-06-01
Completion date
2022-03-31
Last updated
2021-07-02

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

Conditions

Patients With Acute Hypoxemic Respiratory Failure

Brief 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.

Interventions

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.

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.

The patients will undergo conventional weaning protocol. Extubation and subsequent oxygen therapy with venturi mask will be performed after successful spontaneous trial.

Sponsors

Beijing Chao Yang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

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

Inclusion criteria

1. Orotracheal intubation; 2. PaO2 \<60mmHg(venturi mask,FiO2=0.5),and PaCO2 ≤45mmHg; 3. Meeting criteria for weaning readiness; 4. Spontaneous breathing trial failure.

Exclusion criteria

1. Age\<18; 2. Duration of invasive ventilation \<48h; 3. Tracheotomy; 4. Percentage of cuff leak volume in tidal volume\<15.5%; 5. Unable to spontaneously clear secretions from their airway; 6. Recent oral,nasal,facial or cranial trauma or surgery; 7. Recent gastric or esophageal surgery; 8. Active upper gastro-intestinal bleeding; 9. Severe abdominal distension; 10. Lack of co-operation; 11. Chronic respiratory disease such as chronic obstructive pulmonary disease, asthma, interstitial lung disease and neuromuscular disease.

Design outcomes

Primary

MeasureTime frame
Duration of invasive mechanical ventilation2.5 years

Countries

China

Contacts

Primary ContactZujin Luo, MD
xmjg2002@163.com10-86-51718564

Outcome results

None listed

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