Comparison of HFNC With NIV in Weaning COPD

Study Overview
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Brief Summary
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High flow nasal cannula (HFNC) has been shown to improve oxygenation and facilitate weaning in hypoxemia patients. Some clinical studies show the benefits of using HFNC in COPD patients, including reducing dead space and work of breathing. However, no clinical study has been to investigate the value of HFNC in weaning COPD patients from invasive ventilation. Thus, we proposed a randomized controlled trial to compare the use of HFNC and noninvasive ventilation (NIV) in weaning COPD.

Detailed Description
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High flow nasal cannula (HFNC) provides high concentration oxygen in a high flow, which exceeds patient's inspiratory flow demand, to improve oxygenation. In a recent meta-analysis of seven trials with 1771 patients, HFNC was shown to improve oxygenation and avoid intubation in patients with severe hypoxemia. The high velocity of the gas can rinse the dead space of the upper airway and reduce CO2 rebreathing, reduce COPD patients' work of breathing and improve the dynamic compliance of respiratory system. Thus, we proposed a randomized controlled trial to investigate the value of high flow nasal cannula in weaning AECOPD patients from invasive ventilation, with comparison of noninvasive ventilation.

Official Title
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Comparison of High Flow Nasal Cannula With Noninvasive Ventilation in Facilitating Weaning Chronic Obstructive Pulmonary Disease From Invasive Ventilation: a Prospective Randomized Controlled Study

Conditions
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Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation

Intervention / Treatment
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* Device: High flow nasal cannula
* Device: Noninvasive ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Intubated patients with Chronic obstructive pulmonary disease exacerbation Meeting extubation criteria (Pulmonary infection control window) Age > 21years and < 90 years Exclusion Criteria: Tracheotomy Combined with severe dysfunction of other organs, including heart, brain, liver, and renal failure; Hemodynamic instability Contraindication to NIV: cannot use mask, such as facial injury, burns or deformities; cannot cooperate with NIV such as delirium; copious secretions with weak cough ability; gastric over distention, and vomiting; Contraindication to HFNC: rhinitis, nasal congestion, deformities or blockage. Weak cough ability with copious secretions Refuse to participate in the study

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High flow nasal cannula<br>High flow nasal cannula (HFNC) is a type of oxygen device, which provides high concentration oxygen in a high flow, which exceeds patient's inspiratory flow demand, to improve oxygenation. | Device: High flow nasal cannula<br>* High-flow nasal cannula (HFNC) oxygen therapy is a recent technique delivering a high flow of heated and humidified gas. HFNC is simpler to use and apply than noninvasive ventilation (NIV) and appears to be a good alternative treatment for hypoxemic acute respiratory failure (ARF). HFNC is better tolerated than NIV, delivers high fraction of inspired oxygen (FiO2), generates a low level of positive pressure and provides washout of dead space in the upper airways, thereby improving mechanical pulmonary properties and unloading inspiratory muscles during ARF.<br>* Other names: High flow high humidity nasal cannula;|
| Active Comparator: Noninvasive ventilation<br>Non-invasive ventilation (NIV) refers to the provision of ventilatory support through the patient's upper airway using a mask. This technique is distinguished from those which bypass the upper airway with a tracheal tube, laryngeal mask, or tracheostomy and are therefore considered invasive. | Device: Noninvasive ventilation<br>* Non-invasive ventilation (NIV) is the use of airway support administered through a face (nasal) mask instead of an endotracheal tube. Inhaled gases are given with positive end-expiratory pressure often with pressure support or with assist control ventilation at a set tidal volume and rate. Numerous studies have shown this technique to be as effective as, and better tolerated than, intubation and mechanical ventilation in patients with exacerbations of COPD<br>* Other names: Noninvasive positive pressure ventilation; Noninvasive mechanical ventilation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pH | pH | change from the baseline pH within 48 hours | 
| PaCO2 | PaCO2 in mmHg | change from the baseline PaCO2 within 48 hours | 
| PaO2/FiO2 | partial pressure of oxygen in arterial blood/ fraction of inspired oxygen in mmHg | change from the baseline PaO2/FiO2 within 48 hours | 
| HR | Heart Rate in beats per minute | change from the baseline HR within 48 hours | 
| MAP | mean arterial pressure in mmHg | change from the baseline MAP within 48 hours | 
| RR | respiratory rate in breaths per minute | change from the baseline RR within 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of respiratory support | hours of ventilator use | 28 days | 
| Length of ICU stay | Days of stay in ICU | 28 days | 
| Mortality |  | 28 days | 
| the patients' comfort score | comfort score of using high flow nasal cannula or noninvasive ventilator, ranging from 1 to 10. 1 means very comfortable, 10 means very uncomfortable. | 48 hours | 
| incidence of nasal trauma |  | 28 days | 
| incidence of barotrauma |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weaning; Noninvasive ventilation; High flow nasal cannula