Efficacy of NIV Masks in COPD

Fisher & Paykel Healthcare

Status: Completed

Conditions: COPD

Treatments: Device: Comparator Mask; Device: Investigation Mask

Study type: Interventional

Funder types: Industry

Identifiers

NCT04947852

CIA293

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Investigation Mask

Experimental group

Description:

Bi Level CPAP Mask

Treatment:

Device: Comparator Mask

Device: Investigation Mask

Comparator Mask

Active Comparator group

Description:

Bi Level CPAP Mask

Treatment:

Device: Comparator Mask

Device: Investigation Mask