Efficacy of High-intensity NPPV and Low-intensity NPPV in Patients With Chronic Hypercapnic COPD

Not Applicable

• Conditions: COPD; Hypercapnic Respiratory Failure

• Registration Number: NCT03238014
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Brief Summary

High-intensity noninvasive positive pressure ventilation (NPPV), which can well improve the gas exchange and reduce the work of breathing of patients, is a new strategy targeted at maximally reducing arterial carbon dioxide. However, no definitive conclusions have been drawn to decide whether high-intensity NPPV is the best setting for treating patients with chronic hypercapnic COPD. For now, no unified method for setting up high-pressure NPPV has been established. Most of the trials utilized gradually increased inspiratory positive airway pressure depending on the patient's tolerance. However, from a respiratory physiology point of view, excessive inspiratory positive airway pressure may lead to lung hyperinflation, increased intrinsic positive end expiratory pressures, increased oxygen consumption, and ineffective work of breathing.Therefore, seeking a method to establish individualized high-intensity NPPV is of vital importance.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-07-31
• Study Start: 2017-08-01
• Study First Posted: 2017-08-03
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Clinically stable with chronic hypercapnic COPD (baseline arterial carbon dioxide pressure (PaCO2) of 50 mmHg or higher, measured resting in a sitting position and breathing room air without having used NPPV for at least 1 hour)

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Partial pressure of arterial blood carbon dioxide (PaCO2)	12 weeks	Daytime arterial blood gas samples were taken with patients resting in a sitting position and breathing room air without having used NPPV for at least 1 hour.

Secondary Outcome Measures

Name	Time	Method
COPD assessment test	12 weeks	The COPD Assessment Test is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time.
Chromic Respiratory Questionnaire	12 weeks	Chromic Respiratory Questionnaire is uesd to measure the health related quality of life in patients with chronic respiratory disease.
Severe Respiratory Insufficiency (SRI) Questionnaire	12 weeks	The SRI Questionnaire has good psychometric properties shown to be valid for chronic hypercapnic COPD patients receiving NPPV. It includes 49 items on seven subscales.
Baseline Dyspnea Index/Transition Dyspnea Index	12 weeks	Baseline Dyspnea Index/Transition Dyspnea Index provides a multidimensional measurement of dyspnea based on 3 components that evoke dyspnea in activities of daily living, in symptomatic individuals.
Pulmonary function	12 weeks	Pulmonary function tests of lung mechanics - measurements of forced vital capacity, forced expiratory volume in 1 second, forced inspiratory flow rates, etc.
6-minute walk test	12 weeks	The 6-minute walk test plays a key role in evaluating functional exercise capacity, assessing prognosis and evaluating response to treatment across a wide range of respiratory diseases.

Trial Locations

Locations (1)

Guangzhou Institute of Respiratory Disease; 🇨🇳 Guangzhou, Guangdong, China