Efficacy of NIV Masks in COPD

Not Applicable

Completed

• Conditions: COPD
• Interventions: Device: Investigation Mask; Device: Comparator Mask

• Registration Number: NCT04947852
• Lead Sponsor: Fisher and Paykel Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-24
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-07-01
• Study Start: 2021-07-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Primary Completion: 2022-03-17
• Study Completion: 2022-03-17
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Investigation Mask	Comparator Mask	Bi Level CPAP Mask
Comparator Mask	Comparator Mask	Bi Level CPAP Mask
Comparator Mask	Investigation Mask	Bi Level CPAP Mask
Investigation Mask	Investigation Mask	Bi Level CPAP Mask

Primary Outcome Measures

Name	Time	Method
Transcutaneous Carbon Dioxide	60 minutes	mmHg

Secondary Outcome Measures

Name	Time	Method
Minute Ventilation	60 minutes	Litres
Respiratory Rate	60 minutes	Breaths per minute
Oxygen Saturation	60 minutes	Percentage
Heart Rate	60 minutes	Beats per minute
Borg Dyspnoea Score	60 Minutes	1-6 Ranking, with 1 being best and 6 being worst

Trial Locations

Locations (1)

Medical Research Institute New Zealand; 🇳🇿 Wellington, New Zealand