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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02439333
Enrollment
320
Registered
2015-05-08
Start date
2015-07-31
Completion date
2019-07-15
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases, Obstructive

Keywords

Acute exacerbation of chronic obstructive pulmonary disease, Nasal high flow therapy, Oxygen therapy

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.

Interventions

DEVICEnasal catheter or Venturi mask

Conventional oxygen therapy

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

Nasal high flow therapy

Sponsors

Li Xuyan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Treatment failure criteria5 daysPatients with mild respiratory acidosis (7.25 \< pH \< 7.35) with obvious dyspnea (accessory respiratory muscle involvement, breathing rate greater than 25 beats per minute)

Secondary

MeasureTime frame
Length of hospital stay30 days
Costs of hospitalization expenses30 days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026