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Clinical Trials/NCT03238014
NCT03238014
Unknown
Not Applicable

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

The First Affiliated Hospital of Guangzhou Medical University1 site in 1 country14 target enrollmentAugust 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Enrollment
14
Locations
1
Primary Endpoint
Partial pressure of arterial blood carbon dioxide (PaCO2)
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2017
End Date
May 1, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Responsible Party
Principal Investigator
Principal Investigator

Guan Lili

Principal Investigator

The First Affiliated Hospital of Guangzhou Medical University

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

Outcomes

Primary Outcomes

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 Outcomes

  • COPD assessment test(12 weeks)
  • Chromic Respiratory Questionnaire(12 weeks)
  • Severe Respiratory Insufficiency (SRI) Questionnaire(12 weeks)
  • Baseline Dyspnea Index/Transition Dyspnea Index(12 weeks)
  • Pulmonary function(12 weeks)
  • 6-minute walk test(12 weeks)

Study Sites (1)

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