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

Primary Purpose

COPD, Hypercapnic Respiratory Failure

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Noninvasive positive pressure ventilation
Sponsored by
The First Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guangzhou Institute of Respiratory DiseaseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-intensity noninvasive ventilation

Low-intensity noninvasive ventilation

Arm Description

High-intensity noninvasive positive pressure ventilation aims at maximally improving PaCO2.

Low-intensity noninvasive positive pressure ventilation is a classic setting of noninvasive ventilation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Chromic Respiratory Questionnaire
Chromic Respiratory Questionnaire is uesd to measure the health related quality of life in patients with chronic respiratory disease.
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.
Pulmonary function
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
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.

Full Information

First Posted
July 27, 2017
Last Updated
February 4, 2020
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03238014
Brief Title
Efficacy of High-intensity NPPV and Low-intensity NPPV in Patients With Chronic Hypercapnic COPD
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
May 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Hypercapnic Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-intensity noninvasive ventilation
Arm Type
Experimental
Arm Description
High-intensity noninvasive positive pressure ventilation aims at maximally improving PaCO2.
Arm Title
Low-intensity noninvasive ventilation
Arm Type
Active Comparator
Arm Description
Low-intensity noninvasive positive pressure ventilation is a classic setting of noninvasive ventilation.
Intervention Type
Device
Intervention Name(s)
Noninvasive positive pressure ventilation
Other Intervention Name(s)
Noninvasive ventilation
Intervention Description
Noninvasive positive pressure ventilation used assist/control mode treat severe stable chronic obstructive pulmonary disease.
Primary Outcome Measure Information:
Title
Partial pressure of arterial blood carbon dioxide (PaCO2)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Severe Respiratory Insufficiency (SRI) Questionnaire
Description
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.
Time Frame
12 weeks
Title
Baseline Dyspnea Index/Transition Dyspnea Index
Description
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.
Time Frame
12 weeks
Title
Chromic Respiratory Questionnaire
Description
Chromic Respiratory Questionnaire is uesd to measure the health related quality of life in patients with chronic respiratory disease.
Time Frame
12 weeks
Title
COPD assessment test
Description
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.
Time Frame
12 weeks
Title
Pulmonary function
Description
Pulmonary function tests of lung mechanics - measurements of forced vital capacity, forced expiratory volume in 1 second, forced inspiratory flow rates, etc.
Time Frame
12 weeks
Title
6-minute walk test
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lili Guan
Phone
+8613422288665
Email
dr_nickguan@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Luqian Zhou
Phone
+8613826098411
Email
icelucy@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rongchang Chen
Organizational Affiliation
Guangzhou Institute of Respiratory Disease
Official's Role
Study Director
Facility Information:
Facility Name
Guangzhou Institute of Respiratory Disease
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongchang Chen
Phone
+8615622236759
Email
chenrcstatekeylab@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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