Wean Early With HFNCO vs NPPV in Patients With AHRF

Patients With Acute Hypoxemic Respiratory Failure Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03171935
• Other study ID #: BeijingCYH-ICU-005
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: March 31, 2022

Study information

• Verified date: June 2021
• Source: Beijing Chao Yang Hospital
• Contact: Zujin Luo, MD
• Phone: 10-86-51718564
• Email: xmjg2002[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Patients With Acute Hypoxemic Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of invasive mechanical ventilation		2.5 years