Clinical trial NCT02439333: Prospective Randomized Study of Nasal High Flow in Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases, Obstructive
Keywords: Acute exacerbation of chronic obstructive pulmonary disease
Nasal high flow therapy
Oxygen therapy
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 320
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Treatment failure criteria
timeFrame: 5 days
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 30 days
measure: Costs of hospitalization expenses
timeFrame: 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of respiratory and critical care medicine,Beijing Chao-yang Hospital
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Bing Sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li XY, Tang X, Wang R, Yuan X, Zhao Y, Wang L, Li HC, Chu HW, Li J, Mao WP, Wang YJ, Tian ZH, Liu JH, Luo Q, Sun B, Tong ZH. High-Flow Nasal Cannula for Chronic Obstructive Pulmonary Disease with Acute Compensated Hypercapnic Respiratory Failure: A Randomized, Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2020 Nov 24;15:3051-3061. doi: 10.2147/COPD.S283020. eCollection 2020.