Respiratory Support in Severe Chronic Obstructive Pulmonary Disease Exacerbation

NCT ID: NCT03020394

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 208 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2020-12-31

Brief 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.

Detailed 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.

Conditions

COPD Exacerbation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Noninvasive ventilation

Noninvasive positive pressure ventilation is achieved by Philips Respironics V60/Vision ventilator. Choose bilevel positive airway pressure mode, and adjust the fraction of inspire oxygen(FiO2) or oxygen flow rate to maintain patient's oxygen saturation(SpO2) between 88% to 92%. Parameter adjustment and weaning of NPPV follow the protocols used before.

No interventions assigned to this group

Invasive ventilation

Intubated immediately and connected to the ventilator. Parameter adjustment and weaning of IPPV follow the protocols used before.

No interventions assigned to this group

High flow nasal cannula

High flow nasal cannula of different models (large, medium and small) are selected depending on the size and comfort of the patient's nostrils. Adjusting the oxygen flow rate (O2 Flow) maintains the patient's SpO2 88% to 92%. The flow was initially adjusted to 25 L/min and the flow was gradually adjusted to the patient's maximum tolerance. The inspiratory gas temperature (31 to 37 °C) was set to the patient's maximum tolerance level. If the patient's condition deteriorates and the tracheal intubation standard is met , the patient is recommended to undergo invasive ventilation treatment, but the choice of the final respiratory support method should be decided by the attending physician, patient and family.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• AECOPD;

Exclusion Criteria

• refuse to engage in the study;
• have been included in other study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Qingyuan Zhan

Head of Pulmonary and Critical care medicine ward 4

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qingyuan Zhan, M.D.

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Locations

China-Japan Friendship hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jingen Xia, Master

Role: CONTACT

xiajingen_00632@163.com

13466396561

Facility Contacts

Chen Wang, MD

Role: primary

Other Identifiers

2016YFC1304304-3

Identifier Type: -

Identifier Source: org_study_id