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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2019-07-15

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.

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Detailed Description

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Conditions

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Lung Diseases, Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nasal high flow therapy

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Nasal high flow therapy

Conventional oxygen therapy

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.

Group Type ACTIVE_COMPARATOR

nasal catheter or Venturi mask

Intervention Type DEVICE

Conventional oxygen therapy

Interventions

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

Nasal high flow therapy

Intervention Type DEVICE

nasal catheter or Venturi mask

Conventional oxygen therapy

Intervention Type DEVICE

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.)

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No