Wean Early With HFNCO vs NPPV in Patients With AHRF

Sponsor

Beijing Chao Yang Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03171935

Collaborator

(none)

270

Enrollment

Location

Arms

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Patients With Acute Hypoxemic Respiratory Failure	Device: High-Flow Nasal Cannula Oxygenation Device: Noninvasive Positive Pressure Ventilation Device: Conventional weaning	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

270 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Jun 1, 2017

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Duration of invasive mechanical ventilation [2.5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Institute of Respiratory Medicine, Department of respiratory and critical care medicine, Beijing Chao-Yang Hospital Jingxi Campus, Capital Medical University	Beijing		China

Sponsors and Collaborators

Beijing Chao Yang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zujin Luo, MD, Beijing Chao Yang Hospital

ClinicalTrials.gov Identifier:

NCT03171935

Other Study ID Numbers:

BeijingCYH-ICU-005

First Posted:

May 31, 2017

Last Update Posted:

Jul 2, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Insufficiency

Study Results

No Results Posted as of Jul 2, 2021