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

Primary Purpose

COPD Exacerbation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High flow nasal cannula
Sponsored by
China-Japan Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD Exacerbation focused on measuring COPD Exacerbation, High Flow Oxygen, Noninvasive Positive Ventilation, moderate

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • China-Japan Friendship hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

High flow nasal cannula

Noninvasive positive ventilation

Arm Description

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.

Parameters are set according to NPPV protocols

Outcomes

Primary Outcome Measures

endotracheal intubation demand rate

Secondary Outcome Measures

actual endotracheal intubation rate

Full Information

First Posted
January 6, 2017
Last Updated
January 13, 2020
Sponsor
China-Japan Friendship Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03014869
Brief Title
High Flow Nasal Cannula vs NPPV in Moderate Chronic Obstructive Pulmonary Disease Exacerbation
Official Title
Comparison of High Flow Nasal Cannula and Noninvasive Positive Ventilation(NPPV) in Moderate Chronic Obstructive Pulmonary Disease Exacerbation(AECOPD)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China-Japan Friendship Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation
Keywords
COPD Exacerbation, High Flow Oxygen, Noninvasive Positive Ventilation, moderate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
351 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High flow nasal cannula
Arm Type
Experimental
Arm Description
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.
Arm Title
Noninvasive positive ventilation
Arm Type
No Intervention
Arm Description
Parameters are set according to NPPV protocols
Intervention Type
Device
Intervention Name(s)
High flow nasal cannula
Other Intervention Name(s)
High flow oxygen
Intervention Description
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.
Primary Outcome Measure Information:
Title
endotracheal intubation demand rate
Time Frame
90days
Secondary Outcome Measure Information:
Title
actual endotracheal intubation rate
Time Frame
90days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingen Xia, Master
Phone
13466396561
Ext
+86
Email
xiajingen_00632@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingyuan Zhan, M.D.
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China-Japan Friendship hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100028
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Wang, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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