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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2020-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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COPD Hypercapnic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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High-intensity noninvasive ventilation

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

Group Type EXPERIMENTAL

Noninvasive positive pressure ventilation

Intervention Type DEVICE

Noninvasive positive pressure ventilation used assist/control mode treat severe stable chronic obstructive pulmonary disease.

Low-intensity noninvasive ventilation

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

Group Type ACTIVE_COMPARATOR

Noninvasive positive pressure ventilation

Intervention Type DEVICE

Noninvasive positive pressure ventilation used assist/control mode treat severe stable chronic obstructive pulmonary disease.

Interventions

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Noninvasive positive pressure ventilation

Noninvasive positive pressure ventilation used assist/control mode treat severe stable chronic obstructive pulmonary disease.

Intervention Type DEVICE

Other Intervention Names

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Noninvasive ventilation

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No