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

China-Japan Friendship Hospital

Status: Unknown

Conditions: COPD Exacerbation

Treatments: Device: High flow nasal cannula

Study type: Interventional

Funder types: Other

Identifiers

NCT03014869

2016YFC1304304-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 351 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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351 participants in 2 patient groups

High flow nasal cannula

Experimental group

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.

Treatment:

Device: High flow nasal cannula

Noninvasive positive ventilation

No Intervention group

Description:

Parameters are set according to NPPV protocols