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)

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.

Study Overview

• Status: Recruiting
• Conditions: Patients With Acute Hypoxemic Respiratory Failure
• Intervention / Treatment: Device: High-Flow Nasal Cannula Oxygenation; Device: Noninvasive Positive Pressure Ventilation; Device: Conventional weaning

• Study Type: Interventional
• Enrollment (Anticipated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zujin Luo, MD; Phone Number: 10-86-51718564; Email: xmjg2002@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Institute of Respiratory Medicine, Department of respiratory and critical care medicine, Beijing Chao-Yang Hospital Jingxi Campus, Capital Medical University
    • Contact: Zujin Luo, MD; Phone Number: 86-10-51718564; Email: xmjg2002@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-Flow Nasal Cannula Oxygenation	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.
Experimental: Noninvasive Positive Pressure Ventilation	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.
Active Comparator: Conventional Weaning	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of invasive mechanical ventilation	2.5 years

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: May 29, 2017
• First Submitted That Met QC Criteria: May 29, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: BeijingCYH-ICU-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No