Prospective Randomized Study of Nasal High Flow in Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Li Xuyan

Status: Completed

Conditions: Lung Diseases, Obstructive

Treatments: Device: Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand); Device: nasal catheter or Venturi mask

Study type: Interventional

Funder types: Other

Identifiers

NCT02439333

2015-KE-63

Details and patient eligibility

About

The main oxygen therapy to the patients with acute exacerbation of Chronic obstructive pulmonary disease, who are mild to moderate respiratory insufficiency (arterial blood gas analysis showed pH = 7.35, PO2 < 60mmHg,PaCO2>45mmHg) or have achieved the traditional noninvasive ventilation support standard but can not tolerate or reject, was nasal catheter, venturi mask and other conventional oxygen therapy. All these inaccurate inhaled oxygen concentration methods with inadequate heating and humidifying lead to poor patient tolerance and adverse reactions such as airway secretions discharge disorders. The high flow nasal respiratory therapy (Nasal high flow, NHF) utilises higher gas flow rates than conventional low-flow oxygen systems. The devices used deliver heated and humidified oxygen at a flow of up to 60 litres per minute via nasal cannulas with low level continous positive airway pressure. This study is a prospective randomized study. AECOPD patients with no severe respiratory failure are treated with NHF and conventional oxygen therapy respectively. The target is that NHF can increase the comfort degree of patients,reduce the rate of endotracheal intubation, and shorten the time of hospitalization.

Enrollment: 320 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• AECOPD patients.
• The results of blood gas analysis showed pH ≥7.35, PO2< 60mmHg, PaCO2> 45mmHg.

Exclusion criteria

• The study case has been incorporated into the hospital again.
• Refused to the NHF therapy.
• The Glasgow score < 8.
• Severe organ dysfunction (including liver and kidney dysfunction, decompensated acidosis, upper gastrointestinal bleeding, DIC, etc.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Nasal high flow therapy

Active Comparator group

Description:

AECOPD patients with no severe respiratory insufficiency are given NHF therapy for at least 15 hours per day.

Treatment:

Device: Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand)

Conventional oxygen therapy

Active Comparator group

Description:

AECOPD patients with no severe respiratory insufficiency are given conventional oxygen therapy such as nasal catheter or venturi mask for at least 15 hours per day.

Treatment:

Device: nasal catheter or Venturi mask