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

COPD Clinical Trial

— NPPV;COPD  

Official title:

Efficacy of High-intensity Noninvasive Positive Pressure Ventilation and Low-intensity Noninvasive Positive Pressure Ventilation in Patients With Chronic Hypercapnic Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03238014
• Other study ID #: GIRD201707
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: February 2020
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Lili Guan
• Phone: +8613422288665
• Email: dr_nickguan[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Hypercapnia
• Hypercapnic Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Noninvasive positive pressure ventilation
Noninvasive positive pressure ventilation used assist/control mode treat severe stable chronic obstructive pulmonary disease.

Locations

Country	Name	City	State
China	Guangzhou Institute of Respiratory Disease	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Partial pressure of arterial blood carbon dioxide (PaCO2)	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.	12 weeks
Secondary	Severe Respiratory Insufficiency (SRI) Questionnaire	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.	12 weeks
Secondary	Baseline Dyspnea Index/Transition Dyspnea Index	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.	12 weeks
Secondary	Chromic Respiratory Questionnaire	Chromic Respiratory Questionnaire is uesd to measure the health related quality of life in patients with chronic respiratory disease.	12 weeks
Secondary	COPD assessment test	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.	12 weeks
Secondary	Pulmonary function	Pulmonary function tests of lung mechanics - measurements of forced vital capacity, forced expiratory volume in 1 second, forced inspiratory flow rates, etc.	12 weeks
Secondary	6-minute walk test	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.	12 weeks