Comparison of HFNC With NIV in Weaning COPD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03458364|
Recruitment Status : Completed
First Posted : March 8, 2018
Last Update Posted : August 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation||Device: High flow nasal cannula Device: Noninvasive ventilation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of High Flow Nasal Cannula With Noninvasive Ventilation in Facilitating Weaning Chronic Obstructive Pulmonary Disease From Invasive Ventilation: a Prospective Randomized Controlled Study|
|Actual Study Start Date :||January 1, 2017|
|Actual Primary Completion Date :||July 1, 2018|
|Actual Study Completion Date :||July 30, 2018|
Experimental: High flow nasal cannula
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
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.
Other Name: High flow high humidity nasal cannula
Active Comparator: Noninvasive ventilation
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
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
Other Name: Noninvasive positive pressure ventilation; Noninvasive mechanical ventilation
- pH [ Time Frame: change from the baseline pH within 48 hours ]pH
- PaCO2 [ Time Frame: change from the baseline PaCO2 within 48 hours ]PaCO2 in mmHg
- PaO2/FiO2 [ Time Frame: change from the baseline PaO2/FiO2 within 48 hours ]partial pressure of oxygen in arterial blood/ fraction of inspired oxygen in mmHg
- HR [ Time Frame: change from the baseline HR within 48 hours ]Heart Rate in beats per minute
- MAP [ Time Frame: change from the baseline MAP within 48 hours ]mean arterial pressure in mmHg
- RR [ Time Frame: change from the baseline RR within 48 hours ]respiratory rate in breaths per minute
- duration of respiratory support [ Time Frame: 28 days ]hours of ventilator use
- Length of ICU stay [ Time Frame: 28 days ]Days of stay in ICU
- Mortality [ Time Frame: 28 days ]
- the patients' comfort score [ Time Frame: 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 [ Time Frame: 28 days ]
- incidence of barotrauma [ Time Frame: 28 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458364
|Binzhou Medical University Hospital|
|Yantai, Shandong, China, 264003|
|Study Chair:||Xiaozhi Wang, MD||Binzhou Medical University|