Respiratory Support in Severe Chronic Obstructive Pulmonary Disease Exacerbation

NCT03020394 | Unknown

• 1 other identifier: 2016YFC1304304-3
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Exacerbation

Keywords

COPD Exacerbation; Noninvasive Positive Ventilation; Invasive Positive Ventilation; severe; High flow nasal cannula

Outcome Measures

Primary Outcomes (2)

• The incidence of ventilator-associated pneumonia (VAP)

  90days

• The all cause mortality of ICU and hospitalization

  90 days

Secondary Outcomes (2)

• The length of stay of ICU and hospitalization

  90 days

• The length of stay of mechanical ventilation

  90 days

Study Arms (3)

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.

Invasive ventilation

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

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with acute exacerbation of chronic obstructive pulmonary disease in medical ICU.

You may qualify if:

• AECOPD;

You may not qualify if:

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

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship hospital

Beijing, Beijing Municipality, 100028, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Qingyuan Zhan, M.D.

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingen Xia, Master

CONTACT

13466396561; xiajingen_00632@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pulmonary and Critical care medicine ward 4

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 13, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)