NCT04947852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

July 28, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2022

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

8 months

First QC Date

June 24, 2021

Last Update Submit

March 16, 2022

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

  • Transcutaneous Carbon Dioxide

    mmHg

    60 minutes

Secondary Outcomes (5)

  • Oxygen Saturation

    60 minutes

  • Minute Ventilation

    60 minutes

  • Heart Rate

    60 minutes

  • Respiratory Rate

    60 minutes

  • Borg Dyspnoea Score

    60 Minutes

Study Arms (2)

Investigation Mask

EXPERIMENTAL

Bi Level CPAP Mask

Device: Investigation MaskDevice: Comparator Mask

Comparator Mask

ACTIVE COMPARATOR

Bi Level CPAP Mask

Device: Investigation MaskDevice: Comparator Mask

Interventions

Investigation MaskDEVICE

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

Comparator MaskInvestigation Mask
Comparator MaskDEVICE

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

Comparator MaskInvestigation Mask

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Institute New Zealand

Wellington, 6021, New Zealand

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alex Semprini

    Medical Research Institute of New Zealand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2021

First Posted

July 1, 2021

Study Start

July 28, 2021

Primary Completion

March 17, 2022

Study Completion

March 17, 2022

Last Updated

March 18, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

There is no plan to make IPD available.

Locations

NZ(1)