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High Flow Nasal Cannula vs NPPV in Moderate Chronic Obstructive Pulmonary Disease Exacerbation

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ClinicalTrials.gov Identifier: NCT03014869
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Qingyuan Zhan, China-Japan Friendship Hospital

Brief Summary:
For moderate AECOPD(pH<7.35), several guidelines have strongly recommended NPPV as standard therapy, which can reduce the rate of intubation and mortality. A few previous studies have shown that HFNC can efficiently improve alveoli ventilation and breathing pattern in some severe AECOPD patients. Therefore, we hypothesize that HFNC is not inferior to NPPV for preventing endotracheal intubation in moderate AECOPD patients. To assess this hypothesis, we performed a multicenter, randomized, noninferiority trial of HFNV vs NPPV in moderate AECOPD patients.

Condition or disease Intervention/treatment Phase
COPD Exacerbation Device: High flow nasal cannula Not Applicable

Detailed Description:
Recently, many clinical studies have showed that HFNC can be successfully used in patients with hypoxemic respiratory failure to improve the comfort, to attenuate respiratory failure and to decrease the rate of tracheal intubation and mortality. Although theoretically HFNC is a potential and ideal treatment for AECOPD patients, the related clinical researches are very few. It still needs to further evaluate the safety and efficacy of HFNC in patients with AECOPD. For moderate AECOPD(pH<7.35), several guidelines have strongly recommended NPPV as standard therapy, which can reduce the rate of intubation and mortality. A few previous studies have shown that HFNC can efficiently improve alveoli ventilation and breathing pattern in some severe AECOPD patients. Therefore, we hypothesize that HFNC is not inferior to NPPV for preventing endotracheal intubation in moderate AECOPD patients. To assess this hypothesis, we performed a multicenter, randomized, noninferiority trial of HFNV vs NPPV in moderate AECOPD patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 351 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of High Flow Nasal Cannula and Noninvasive Positive Ventilation(NPPV) in Moderate Chronic Obstructive Pulmonary Disease Exacerbation(AECOPD)
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: High flow nasal cannula
High flow nasal cannula(OptiflowTM); Flow 25-60 L/min is set according to patients' comfort; FiO2 is adjusted to maintain peripheral capillary oxygen saturation(SpO2) 90-95%; temperature is set at 37 degree centigrade.
Device: High flow nasal cannula
High flow nasal cannula (HFNC) is a new emerging noninvasive respiratory support technology, which mainly includes high flow (15-60 L/min) device, heating humidification device and nasal cannula for high flow. A large number of physiological studies confirmed that HFNC has the following critical physiological effects: promoting airway humidification, improving tolerance of treatment, reducing the physiological dead space on the upper respiratory tract, producing a certain level of positive end expiratory pressure (2-7 cmH2O), decreasing the work of breathing and so on.
Other Name: High flow oxygen

No Intervention: Noninvasive positive ventilation
Parameters are set according to NPPV protocols



Primary Outcome Measures :
  1. endotracheal intubation demand rate [ Time Frame: 90days ]

Secondary Outcome Measures :
  1. actual endotracheal intubation rate [ Time Frame: 90days ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • AECOPD; 7.35>pH≥7.25,PaCO2>50 mmHg

Exclusion Criteria:

  • contraindications for NPPV, such as thick sputum, cough weakness, hemodynamic instability, etc.; need to be intubated immediately; 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): NCT03014869


Contacts
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Contact: Jingen Xia, Master 13466396561 ext +86 xiajingen_00632@163.com

Locations
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China, Beijing
China-Japan Friendship hospital Recruiting
Beijing, Beijing, China, 100028
Contact: Chen Wang, MD         
Sponsors and Collaborators
China-Japan Friendship Hospital
Investigators
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Principal Investigator: Qingyuan Zhan, M.D. China-Japan Friendship Hospital
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Responsible Party: Qingyuan Zhan, head of Pulmonary and Critical care medicine ward 4, China-Japan Friendship Hospital
ClinicalTrials.gov Identifier: NCT03014869    
Other Study ID Numbers: 2016YFC1304304-2
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Qingyuan Zhan, China-Japan Friendship Hospital:
COPD Exacerbation
High Flow Oxygen
Noninvasive Positive Ventilation
moderate
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Progression
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes