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

Comparison of High Flow Nasal Cannula and Noninvasive Positive Ventilation(NPPV) in Moderate Chronic Obstructive Pulmonary Disease Exacerbation(AECOPD)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03014869
Enrollment
351
Registered
2017-01-09
Start date
2017-01-31
Completion date
2020-12-31
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Exacerbation

Keywords

COPD Exacerbation, High Flow Oxygen, Noninvasive Positive Ventilation, moderate

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.

Interventions

DEVICEHigh 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.

Sponsors

China-Japan Friendship Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
endotracheal intubation demand rate90days

Secondary

MeasureTime frame
actual endotracheal intubation rate90days

Countries

China

Contacts

Primary ContactJingen Xia, Master
xiajingen_00632@163.com13466396561

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026