Skip to main content
OpenTrials
Completed

NCT Number: NCT04947852

Efficacy of NIV Masks in COPD

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Research Institute New Zealand

Wellington, 6021, New Zealand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Investigation Mask

Device

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

Comparator Mask

Device

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

Primary outcomes

  1. Transcutaneous Carbon Dioxide

    Time frame: 60 minutes

    mmHg

Secondary outcomes

  1. Oxygen Saturation

    Time frame: 60 minutes

    Percentage

  2. Minute Ventilation

    Time frame: 60 minutes

    Litres

  3. Heart Rate

    Time frame: 60 minutes

    Beats per minute

  4. Respiratory Rate

    Time frame: 60 minutes

    Breaths per minute

  5. Borg Dyspnoea Score

    Time frame: 60 Minutes

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

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 1, 2021
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.