NPPV vs IPPV in Severe Chronic Obstructive Pulmonary Disease Exacerbation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03020394|
Recruitment Status : Recruiting
First Posted : January 13, 2017
Last Update Posted : September 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|COPD Exacerbation||Device: Noninvasive ventilation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||208 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Noninvasive Positive Ventilation (NPPV) and Invasive Positive Ventilation (IPPV) in Severe Chronic Obstructive Pulmonary Disease Exacerbation (AECOPD)|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
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.
- 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.
- ICU mortality [ Time Frame: 90days ]
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
|Contact: Jingen Xia, Masterfirstname.lastname@example.org|
|China-Japan Friendship hospital||Recruiting|
|Beijing, Beijing, China, 100028|
|Contact: Chen Wang, MD|
|Principal Investigator:||Qingyuan Zhan, M.D.||China-Japan Friendship Hospital|