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

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

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.

Study Overview

• Status: Unknown
• Conditions: COPD; Hypercapnic Respiratory Failure
• Intervention / Treatment: Device: Noninvasive positive pressure ventilation

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lili Guan; Phone Number: +8613422288665; Email: dr_nickguan@163.com
• Study Contact Backup: Name: Luqian Zhou; Phone Number: +8613826098411; Email: icelucy@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Guangzhou Institute of Respiratory Disease
      • Contact: Rongchang Chen; Phone Number: +8615622236759; Email: chenrcstatekeylab@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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: High-intensity noninvasive ventilation; High-intensity noninvasive positive pressure ventilation aims at maximally improving PaCO2.	Device: Noninvasive positive pressure ventilation; Noninvasive positive pressure ventilation used assist/control mode treat severe stable chronic obstructive pulmonary disease.; Other Names: Noninvasive ventilation
Active Comparator: Low-intensity noninvasive ventilation; Low-intensity noninvasive positive pressure ventilation is a classic setting of noninvasive ventilation.	Device: Noninvasive positive pressure ventilation; Noninvasive positive pressure ventilation used assist/control mode treat severe stable chronic obstructive pulmonary disease.; Other Names: Noninvasive ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Chromic Respiratory Questionnaire	Chromic Respiratory Questionnaire is uesd to measure the health related quality of life in patients with chronic respiratory disease.	12 weeks
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
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
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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Investigators: Study Director: Rongchang Chen, Guangzhou Institute of Respiratory Disease

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypercapnia
• Other Study ID Numbers: GIRD201707

Drug and device information, study documents

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