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)
1 other identifier
interventional
270
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2017
CompletedFirst Posted
Study publicly available on registry
May 31, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedJuly 2, 2021
June 1, 2021
4.6 years
May 29, 2017
June 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of invasive mechanical ventilation
2.5 years
Study Arms (3)
High-Flow Nasal Cannula Oxygenation
EXPERIMENTALNoninvasive Positive Pressure Ventilation
EXPERIMENTALConventional Weaning
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- Orotracheal intubation；
- PaO2 \<60mmHg（venturi mask，FiO2=0.5），and PaCO2 ≤45mmHg；
- Meeting criteria for weaning readiness；
- Spontaneous breathing trial failure.
You may not qualify if:
- Age\<18；
- Duration of invasive ventilation \<48h；
- Tracheotomy；
- Percentage of cuff leak volume in tidal volume\<15.5%；
- Unable to spontaneously clear secretions from their airway；
- Recent oral，nasal，facial or cranial trauma or surgery；
- Recent gastric or esophageal surgery；
- Active upper gastro-intestinal bleeding；
- Severe abdominal distension；
- Lack of co-operation；
- Chronic respiratory disease such as chronic obstructive pulmonary disease, asthma, interstitial lung disease and neuromuscular disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Institute of Respiratory Medicine, Department of respiratory and critical care medicine, Beijing Chao-Yang Hospital Jingxi Campus, Capital Medical University
Beijing, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 29, 2017
First Posted
May 31, 2017
Study Start
June 1, 2017
Primary Completion
December 31, 2021
Study Completion
March 31, 2022
Last Updated
July 2, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share