HFNC vs Nasal Cannula in Mild Chronic Obstructive Pulmonary Disease Exacerbation

COPD Exacerbation Clinical Trial

Official title:

Comparison of High Flow Nasal Cannula vs Nasal Cannula in Mild Chronic Obstructive Pulmonary Disease Exacerbation(AECOPD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03003559
• Other study ID #: 2016YFC1304304-1
• Status: Recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2020

Study information

• Verified date: January 2020
• Source: China-Japan Friendship Hospital
• Contact: Jingen Xia, Master
• Phone: 13466396561
• Email: xiajingen_00632[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For AECOPD patients, only 8% patients ventilated by noninvasive and invasive positive pressure ventilation. Nasal cannula is the most common pattern of oxygen therapy in mild AECOPD. As a low flow oxygen therapy, nasal cannula has many disadvantages.Therefore, we design a randomized controlled trial(RCT)to explore whether HFNC would be better than nasal cannula to prevent the aggravation of respiratory failure and endotracheal intubation in mild AECOPD.

Description:

For AECOPD patients, most of patients don't need respiratory support, only 8% patients ventilated by noninvasive and invasive positive pressure ventilation. Nasal cannula is the most common pattern of oxygen therapy in mild AECOPD. As a low flow oxygen therapy, nasal cannula has many disadvantages: discomfort, low humidity and unstable fraction of inspired oxygen(FiO2) in inspiratory gas. Therefore, we design a RCT to explore whether HFNC would be better than nasal cannula to prevent the aggravation of respiratory failure and endotracheal intubation in mild AECOPD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 328
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• AECOPD; pH=7.35, PaCO2>45 mmHg

Exclusion Criteria:

• Need to be intubated immediately; refuse to engage in the study; severe organ dysfunction

Related Conditions & MeSH terms

• COPD Exacerbation
• Disease Progression
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• High flow nasal cannula
High flow nasal cannula (HFNC) is a new emerging noninvasive respiratory support technology, which mainly includes high flow (15-60 L/min) device, heating humidification device and nasal cannula for high flow. A large number of physiological studies confirmed that HFNC has the following critical physiological effects: promoting airway humidification, improving tolerance of treatment, reducing the physiological dead space on the upper respiratory tract, producing a certain level of positive end expiratory pressure (2-7 cmH2O), decreasing the work of breathing and so on.

Locations

Country	Name	City	State
China	China-Japan Friendship hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endotracheal intubation demand rate		90days
Secondary	actual endotracheal intubation rate		90days