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NPPV vs IPPV in Severe Chronic Obstructive Pulmonary Disease Exacerbation

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ClinicalTrials.gov Identifier: NCT03020394
Recruitment Status : Not yet recruiting
First Posted : January 13, 2017
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
Qingyuan Zhan, China-Japan Friendship Hospital

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.

Condition or disease Intervention/treatment Phase
COPD Exacerbation Device: Noninvasive ventilation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Noninvasive Positive Ventilation (NPPV) and Invasive Positive Ventilation (IPPV) in Severe Chronic Obstructive Pulmonary Disease Exacerbation (AECOPD)
Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: 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.
Device: Noninvasive ventilation
investigators recommended to use 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. NPPV failure is defined as patient needs intubation and invasive mechanical ventilation, but the decision whether or not should be determined by attending physician, the patient and patient's family.
Other Name: Noninvasive positive pressure ventilation

No Intervention: Invasive ventilation
Intubated immediately and connected to the ventilator. Parameter adjustment and weaning of IPPV follow the protocols used before.



Primary Outcome Measures :
  1. incidence of ventilator-associated pneumonia (VAP) [ Time Frame: 90days ]
    if patient is ventilated for more than 90days, the outcome measure is the incidence of VAP in 90days, if the patient takes off the ventilator successfully within 90days, the outcome measure is the incidence of VAP during hospitalization.


Secondary Outcome Measures :
  1. ICU mortality [ Time Frame: 90days ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • AECOPD;
  • 7.25>pH≥7.15 and
  • PaCO2>60 mmHg.

Exclusion Criteria:

  • contraindications for NPPV, such as thick sputum, cough weakness, hemodynamic instability, etc.;
  • need to be intubated immediately;
  • severe pneumonia;
  • refuse to engage in the study;
  • severe organ dysfunction.

Information from the National Library of Medicine

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): NCT03020394


Contacts
Contact: Jingen Xia, Master 13466396561 xiajingen_00632@163.com

Sponsors and Collaborators
China-Japan Friendship Hospital
Investigators
Principal Investigator: Qingyuan Zhan, M.D. China-Japan Friendship Hospital

Responsible Party: Qingyuan Zhan, Head of Pulmonary and Critical care medicine ward 4, China-Japan Friendship Hospital
ClinicalTrials.gov Identifier: NCT03020394     History of Changes
Other Study ID Numbers: 2016YFC1304304-3
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Qingyuan Zhan, China-Japan Friendship Hospital:
COPD Exacerbation
Noninvasive Positive Ventilation
Invasive Positive Ventilation
severe

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Progression
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes