Non-invasive Positive Pressure (NPPV ) for Severe Stable Chronic Obstructive Pulmonary Disease

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

368 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-12-31

Brief Summary

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Assessment of the effect and safety of noninvasive positive pressure ventilation for severe stable chronic obstructive pulmonary disease

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease Hypercapnic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Noninvasive ventilator

noninvasive positive pressure ventilation combined with long-term oxygen therapy for severe stable chronic obstructive pulmonary disease

Group Type EXPERIMENTAL

BiPAP mode

Intervention Type DEVICE

Noninvasive ventilator

LTOT

long-term oxygen therapy for severe stable chronic obstructive pulmonary disease

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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BiPAP mode

Noninvasive ventilator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* clinically stable, hypercapnic GOLD stage IV COPD, aged 18 years or older, baseline arterial carbon dioxide pressure (PaCO2) of 6.7 kPa (50 mmHg) or higher and a pH higher than 7·35, measured after at least 1 h rest in a sitting position.

Exclusion Criteria

* thorax or the lung other than COPD
* No smoking or Cigarette≤10/day
* obesity with a bodymass index (BMI) ≥40 kg/m²
* malignant co-morbidities,severe heart failure (New York Heart Association stage IV),unstable angina, and severe arrhythmias.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No