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

Study Overview
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Brief Summary
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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.

Conditions
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Lung Diseases, Obstructive

Intervention / Treatment
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* Device: Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand)
* Device: nasal catheter or Venturi mask


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nasal high flow therapy<br>AECOPD patients with no severe respiratory insufficiency are given NHF therapy for at least 15 hours per day. | Device: Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand)<br>* Nasal high flow therapy<br>|
| Active Comparator: Conventional oxygen therapy<br>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. | Device: nasal catheter or Venturi mask<br>* Conventional oxygen therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure criteria | Patients with mild respiratory acidosis (7.25 < pH < 7.35) with obvious dyspnea (accessory respiratory muscle involvement, breathing rate greater than 25 beats per minute) | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | 30 days | 
| Costs of hospitalization expenses |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasal high flow therapy, Oxygen therapy, Acute exacerbation of chronic obstructive pulmonary disease