Lung Diseases, Obstructive Clinical Trial
NCT number | NCT02439333 |
Other study ID # | 2015-KE-63 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2015 |
Est. completion date | July 15, 2019 |
Verified date | May 2018 |
Source | Beijing Chao Yang Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 320 |
Est. completion date | July 15, 2019 |
Est. primary completion date | July 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility |
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.) |
Country | Name | City | State |
---|---|---|---|
China | Department of respiratory and critical care medicine,Beijing Chao-yang Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Li Xuyan |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Length of hospital stay | 30 days | ||
Secondary | Costs of hospitalization expenses | 30 days |
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