Efficacy of NIV Masks in COPD

Fisher and Paykel Healthcare16 enrolled

Overview

A randomized controlled pilot study to compare the efficacy and tolerability of a two different NIV masks on carbon dioxide in participants with stable chronic obstructive pulmonary disease (COPD) with chronic type II respiratory failure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

COPD

Interventions

Investigation MaskDEVICE

Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff

Comparator MaskDEVICE

Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A doctor's diagnosis of COPD * PtCO2 ≥45mmHg on transcutaneous monitor at baseline measure * Oxygen saturation measured by pulse oximetry (SpO2) ≥85% * Fits the study mask * Can tolerate the therapy Exclusion Criteria: * FEV1/FVC ≥70% * Body mass index \>35 * Hypercapnia considered to be primarily due to Obesity Hypoventilation syndrome and/or Obstructive Sleep Apnea * Any condition which makes NIV contra-indicated as per BTS guidelines based on clinical judgement

Locations (1)

Medical Research Institute New Zealand

Wellington, New Zealand

Outcomes

Primary Outcomes

Transcutaneous Carbon Dioxide

mmHg

Time frame: 60 minutes

Secondary Outcomes

Oxygen Saturation

Percentage

Time frame: 60 minutes

Minute Ventilation

Litres

Time frame: 60 minutes

Heart Rate

Beats per minute

Time frame: 60 minutes

Respiratory Rate

Breaths per minute

Time frame: 60 minutes

Borg Dyspnoea Score

1-6 Ranking, with 1 being best and 6 being worst

Time frame: 60 Minutes

Data from ClinicalTrials.gov

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