Efficacy of NIV Masks in COPD

Efficacy of NIV Masks in COPD Patients With Chronic Respiratory Failure: A Randomized Controlled Cross Over Pilot

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 Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Device: Investigation Mask; Device: Comparator Mask

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Wellington, New Zealand, 6021
    • Medical Research Institute New Zealand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigation Mask; Bi Level CPAP Mask	Device: Investigation Mask; Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff; Device: Comparator Mask; Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff
Active Comparator: Comparator Mask; Bi Level CPAP Mask	Device: Investigation Mask; Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff; Device: Comparator Mask; Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transcutaneous Carbon Dioxide	mmHg	60 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Alex Semprini, Medical Research Institute of New Zealand

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Actual): March 17, 2022
• Study Completion (Actual): March 17, 2022

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CIA293

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No