COPD
Conditions
Brief summary
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.
Interventions
DEVICEInvestigation Mask
Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff
DEVICEComparator Mask
Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transcutaneous Carbon Dioxide | 60 minutes | mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Saturation | 60 minutes | Percentage |
| Minute Ventilation | 60 minutes | Litres |
| Heart Rate | 60 minutes | Beats per minute |
| Respiratory Rate | 60 minutes | Breaths per minute |
| Borg Dyspnoea Score | 60 Minutes | 1-6 Ranking, with 1 being best and 6 being worst |
Countries
New Zealand
Outcome results
None listed