Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation
Conditions
Keywords
Weaning; Noninvasive ventilation; High flow nasal cannula
Brief summary
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
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.
Interventions
DEVICEHigh flow nasal cannula
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.
DEVICENoninvasive ventilation
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
Sponsors
Binzhou Medical University
Jie Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RR | change from the baseline RR within 48 hours | respiratory rate in breaths per minute |
| pH | change from the baseline pH within 48 hours | pH |
| PaCO2 | change from the baseline PaCO2 within 48 hours | PaCO2 in mmHg |
| PaO2/FiO2 | change from the baseline PaO2/FiO2 within 48 hours | partial pressure of oxygen in arterial blood/ fraction of inspired oxygen in mmHg |
| HR | change from the baseline HR within 48 hours | Heart Rate in beats per minute |
| MAP | change from the baseline MAP within 48 hours | mean arterial pressure in mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of barotrauma | 28 days | — |
| duration of respiratory support | 28 days | hours of ventilator use |
| Length of ICU stay | 28 days | Days of stay in ICU |
| Mortality | 28 days | — |
| the patients' comfort score | 48 hours | comfort score of using high flow nasal cannula or noninvasive ventilator, ranging from 1 to 10. 1 means very comfortable, 10 means very uncomfortable. |
| incidence of nasal trauma | 28 days | — |
Countries
China
Outcome results
None listed