The Physiological Effect of High Flow Oxygen Therapy

The Physiological Effect of High Flow Oxygen Therapy on Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Although non-invasive positive pressure ventilation (NPPV) shows the good curative effect of treating the patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD), some patients do not tolerate NPPV or do not benefit from it. High-flow nasal cannula (HFNC) is well tolerated and may be used to patients with AECOPD who are intolerant to NPPV treatment. This study is to evaluate the physiological effect of HFNC and compare it with NPPV.

Study Overview

• Status: Unknown
• Conditions: High-flow Nasal Cannula; Non-invasive Positive Pressure Ventilation; Acute Exacerbation of Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: HFNC; Device: NPPV

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lili Guan, PhD; Phone Number: +8613422288665; Email: dr_nickguan@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University.
      • Contact: Lili Guan, PhD; Phone Number: +8613422288665; Email: dr_nickguan@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• AECOPD patients with acute hypercapnic respiratory failure

Exclusion Criteria:

• other lung/pleural diseases or thoracic deformity
• severe heart failure (New York Heart Association class IV), severe dysrhythmia
• unstable angina, or malignant comorbidity
• obesity (BMI ≥ 35 kg/m²)
• severe obstructive sleep apnea syndrome

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HFNC group; AECOPD patients receive ventilation support via HFNC.	Device: HFNC; HFNC provides warmed and humidified gas administered through slightly enlarged nasal prongs.
Active Comparator: NPPV group; AECOPD patients receive ventilation support via NPPV.	Device: NPPV; NPPV is the standard therapy for ventilatory failure in AECOPD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neural respiratory drive	Neural respiratory drive is calculated by diaphragm electromyogram	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work of breathing	Work of breathing is calculated by the transdiaphragmatic pressure	30 minutes
Transcutaneous CO2	Transcutaneous CO2 is a non-invasive method estimated the partial pressure of arterial blood CO2.	30 minutes

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Investigators: Study Chair: Rongchang Chen, MD, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2019
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: December 24, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): December 30, 2019
• Last Update Submitted That Met QC Criteria: December 26, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: GIRH-HFNC8306

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No