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

Not Applicable

Completed

• Conditions: Lung Diseases, Obstructive
• Interventions: Device: Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand); Device: nasal catheter or Venturi mask

• Registration Number: NCT02439333
• Lead Sponsor: Li Xuyan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-07
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-08
• Study Start: 2015-07
• Status Verified: 2018-05
• Primary Completion: 2019-07
• Study Completion: 2019-07-15
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal high flow therapy	Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand)	AECOPD patients with no severe respiratory insufficiency are given NHF therapy for at least 15 hours per day.
Conventional oxygen therapy	nasal catheter or Venturi mask	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.

Primary Outcome Measures

Name	Time	Method
Treatment failure criteria	5 days	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)

Secondary Outcome Measures

Name	Time	Method
Costs of hospitalization expenses	30 days
Length of hospital stay	30 days

Trial Locations

Locations (1)

Department of respiratory and critical care medicine,Beijing Chao-yang Hospital; 🇨🇳 Beijing, Beijing, China