NCT05059288

Brief Summary

Assessment of usability, perceived comfort and performance of a NIV mask in the hospital environment.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Status
unknown

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

September 6, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

October 28, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

1.2 years

First QC Date

September 6, 2021

Last Update Submit

September 19, 2021

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Perceived mask performance

    Three point visual analogue scale on preference 1 = Worse, 2 = Same, 3 = Better

    During the intervention

Study Arms (1)

Investigation Mask

EXPERIMENTAL

Non invasive ventilation mask

Device: Investigational Non Invasive Ventilation Mask

Interventions

Investigational Non Invasive Ventilation MaskDEVICE

Oronasal non invasive ventilation mask

Investigation Mask

Eligibility Criteria

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

You may qualify if:

  • Admitted and indicated for non invasive ventilation therapy
  • Assessed for capacity to consent and consent process documented
  • Fits the investigation mask
  • Aged 18 year or older

You may not qualify if:

  • \- Contraindicated for non invasive ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Robert Martynoga

    Waikato Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica R Fogarin

CONTACT

095740100jessica.fogarin@fphcare.co.nz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2021

First Posted

September 28, 2021

Study Start

October 28, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share