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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2019

Interventions

  • Device: Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand)
    • Nasal high flow therapy
  • Device: nasal catheter or Venturi mask
    • Conventional oxygen therapy

Arms, Groups and Cohorts

  • Active Comparator: Nasal high flow therapy
    • AECOPD patients with no severe respiratory insufficiency are given NHF therapy for at least 15 hours per day.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Treatment failure criteria
    • Time Frame: 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 Measures

  • Length of hospital stay
    • Time Frame: 30 days
  • Costs of hospitalization expenses
    • Time Frame: 30 days

Participating in This Clinical Trial

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.)

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Li Xuyan
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Li Xuyan, Sponsor-Investigator – Beijing Chao Yang Hospital
  • Overall Official(s)
    • Bing Sun, MD, Principal Investigator, Beijing Chao Yang Hospital
  • Overall Contact(s)
    • Xuyan Li, MD, 0086-10-85231543, araklee@163.com

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