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

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ClinicalTrials.gov Identifier: NCT03238014
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Guan Lili, 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.

Condition or disease Intervention/treatment Phase
COPD Hypercapnic Respiratory Failure Device: Noninvasive positive pressure ventilation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : August 1, 2018

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 Name: 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 Name: Noninvasive ventilation




Primary Outcome Measures :
  1. Partial pressure of arterial blood carbon dioxide (PaCO2) [ Time Frame: 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 :
  1. Severe Respiratory Insufficiency (SRI) Questionnaire [ Time Frame: 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.

  2. Baseline Dyspnea Index/Transition Dyspnea Index [ Time Frame: 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.

  3. Chromic Respiratory Questionnaire [ Time Frame: 12 weeks ]
    Chromic Respiratory Questionnaire is uesd to measure the health related quality of life in patients with chronic respiratory disease.

  4. COPD assessment test [ Time Frame: 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.

  5. Pulmonary function [ Time Frame: 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. 6-minute walk test [ Time Frame: 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.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238014


Contacts
Contact: Lili Guan +8613422288665 dr_nickguan@163.com
Contact: Luqian Zhou +8613826098411 icelucy@126.com

Locations
China, Guangdong
Guangzhou Institute of Respiratory Disease Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Rongchang Chen    +8615622236759    chenrcstatekeylab@gmail.com   
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Investigators
Study Director: Rongchang Chen Guangzhou Institute of Respiratory Disease

Responsible Party: Guan Lili, Principal Investigator, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT03238014     History of Changes
Other Study ID Numbers: GIRD201707
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Respiratory Insufficiency
Hypercapnia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms