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Completed

NCT Number: NCT02439333

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

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.

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of respiratory and critical care medicine,Beijing Chao-yang Hospital

Beijing, Beijing Municipality, 100020, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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

Device

Nasal high flow therapy

nasal catheter or Venturi mask

Device

Conventional oxygen therapy

Primary outcomes

  1. 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 outcomes

  1. Length of hospital stay

    Time frame: 30 days

  2. Costs of hospitalization expenses

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Li Xuyan

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
May 8, 2015
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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