Respiratory Support in Severe Chronic Obstructive Pulmonary Disease Exacerbation

COPD Exacerbation Clinical Trial

Official title:

Comparison of High Flow Nasal Cannula, Noninvasive Positive Ventilation (NPPV) and Invasive Positive Ventilation (IPPV) in Severe Chronic Obstructive Pulmonary Disease Exacerbation (AECOPD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03020394
• Other study ID #: 2016YFC1304304-3
• Status: Recruiting
• 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: Observational

Clinical Trial Summary

Preliminary studies have shown that NPPV can avoid tracheal intubation in 40% to 60% patients who have severe exacerbation of COPD. Recently, large-scale comparative effectiveness research (CER) also found that compared with invasive ventilation, NPPV can reduce mortality rates. But there's no high-quality clinical studies which can confirm this. Therefore, investigators believe that NPPV can avoid intubation in patients with severe exacerbation of COPD in ICU with perfect monitoring conditions and reasonable human resource allocation, in order to reduce IMV-related complications and improve patients' outcomes.

Description:

In part of the patients who were AECOPD with pH <7.25 , preliminary studies have shown that NPPV can avoid tracheal intubation in 40% to 60% patients, and also reduce the incidence of VAP. Recently, large-scale comparative effectiveness research (CER) also found that compared with invasive ventilation, NPPV can reduce mortality rates. At present, there's no high-quality clinical studies which can confirm this, and clinical guidelines do not have a recommendation on the use of NPPV in these patients. Therefore, investigators believe that NPPV can avoid intubation in patients with severe exacerbation of COPD in ICU with perfect monitoring conditions and reasonable human resource allocation, as well as the progress of medical technology in NPPV in recent years, in order to reduce IMV-related complications and improve patients' outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• 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;

Exclusion Criteria:

• refuse to engage in the study;

• have been included in other study.

Related Conditions & MeSH terms

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

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	The incidence of ventilator-associated pneumonia (VAP)		90days
Primary	The all cause mortality of ICU and hospitalization		90 days
Secondary	The length of stay of ICU and hospitalization		90 days
Secondary	The length of stay of mechanical ventilation		90 days