Back to resultsWean Early With HFNCO vs NPPV in Patients With AHRF
Primary Purpose
Patients With Acute Hypoxemic Respiratory Failure
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High-Flow Nasal Cannula Oxygenation
Noninvasive Positive Pressure Ventilation
Conventional weaning
Sponsored by
About this trial
This is an interventional treatment trial for Patients With Acute Hypoxemic Respiratory Failure
Eligibility Criteria
Inclusion Criteria:
- Orotracheal intubation；
- PaO2 <60mmHg（venturi mask，FiO2=0.5），and PaCO2 ≤45mmHg；
- Meeting criteria for weaning readiness；
- Spontaneous breathing trial failure.
Exclusion Criteria:
- 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.
Sites / Locations
- Beijing Institute of Respiratory Medicine, Department of respiratory and critical care medicine, Beijing Chao-Yang Hospital Jingxi Campus, Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
High-Flow Nasal Cannula Oxygenation
Noninvasive Positive Pressure Ventilation
Conventional Weaning
Arm Description
Outcomes
Primary Outcome Measures
Duration of invasive mechanical ventilation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03171935
Brief Title
Wean Early With HFNCO vs NPPV in Patients With AHRF
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Acute Hypoxemic Respiratory Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
270 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High-Flow Nasal Cannula Oxygenation
Arm Type
Experimental
Arm Title
Noninvasive Positive Pressure Ventilation
Arm Type
Experimental
Arm Title
Conventional Weaning
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
High-Flow Nasal Cannula Oxygenation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Noninvasive Positive Pressure Ventilation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Conventional weaning
Intervention Description
The patients will undergo conventional weaning protocol. Extubation and subsequent oxygen therapy with venturi mask will be performed after successful spontaneous trial.
Primary Outcome Measure Information:
Title
Duration of invasive mechanical ventilation
Time Frame
2.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Orotracheal intubation；
PaO2 <60mmHg（venturi mask，FiO2=0.5），and PaCO2 ≤45mmHg；
Meeting criteria for weaning readiness；
Spontaneous breathing trial failure.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zujin Luo, MD
Phone
10-86-51718564
Email
xmjg2002@163.com
Facility Information:
Facility Name
Beijing Institute of Respiratory Medicine, Department of respiratory and critical care medicine, Beijing Chao-Yang Hospital Jingxi Campus, Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zujin Luo, MD
Phone
86-10-51718564
Email
xmjg2002@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Wean Early With HFNCO vs NPPV in Patients With AHRF
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