Efficacy of NIV Masks in COPD | NCT04947852

Studies
Efficacy of NIV Masks in COPD

NCT04947852

Sponsor

Fisher and Paykel Healthcare

Status

Completed

Last Update Posted

Mar 18, 2022Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

COPD

Interventions

Investigation Mask
Comparator Mask

Countries

New Zealand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 28, 2021Actual

Primary Completion Date

Mar 17, 2022Actual

Completion Date

Mar 17, 2022Actual

First Submitted Date

Jun 24, 2021

First Submission Date that Met QC Criteria

Jun 24, 2021

First Posted Date

Jul 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2022

Last Update Posted Date

Mar 18, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Investigation Mask	Experimental	Bi Level CPAP Mask	Device: Investigation Mask Device: Comparator Mask
Comparator Mask	Active Comparator	Bi Level CPAP Mask	Device: Investigation Mask Device: Comparator Mask

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Investigation Mask	Device	Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff	Comparator Mask Investigation Mask

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Transcutaneous Carbon Dioxide	mmHg	60 minutes

Secondary Outcomes

Measure	Description	Time Frame
Oxygen Saturation	Percentage	60 minutes
Minute Ventilation	Litres	60 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alex Semprini	Medical Research Institute of New Zealand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Research Institute New Zealand		Wellington		6021	New Zealand

IPD Sharing Statement Module

Plan to Share IPD

Description

There is no plan to make IPD available.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided