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

G

Guangzhou Medical University

Status

Unknown

Conditions

Hypercapnic Respiratory Failure
COPD

Treatments

Device: Noninvasive positive pressure ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT03238014
GIRD201707

Details and patient eligibility

About

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.

Enrollment

14 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

14 participants in 2 patient groups

High-intensity noninvasive ventilation
Experimental group
Description:
High-intensity noninvasive positive pressure ventilation aims at maximally improving PaCO2.
Treatment:
Device: Noninvasive positive pressure ventilation
Low-intensity noninvasive ventilation
Active Comparator group
Description:
Low-intensity noninvasive positive pressure ventilation is a classic setting of noninvasive ventilation.
Treatment:
Device: Noninvasive positive pressure ventilation

Trial contacts and locations

1

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Central trial contact

Luqian Zhou; Lili Guan

Data sourced from clinicaltrials.gov

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