NCT04765878

Brief Summary

This study aims to capture preliminary safety and effectiveness information on a near-final humidifier device design and to provide data for more extensive research, if required. This feasibility study will investigate the following: process, resources, management, and scientific aspects of delivering humidification by the RespirAq humidifier device in ventilated patients.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

1 month

First QC Date

February 16, 2021

Last Update Submit

March 8, 2021

Conditions

Mechanical Ventilation

Outcome Measures

Primary Outcomes (2)

  • Temperature

    Meet ISO standard

    max 24 hours

  • Humidity

    Meet ISO standard

    max 24 hours

Study Arms (1)

Humidification

EXPERIMENTAL
Device: RespirAq Humidification

Interventions

RespirAq HumidificationDEVICE

Humidifier

Humidification

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for coronary artery bypass surgery (CABG) will be recruited before their surgical procedure at the Waikato district health board during February, March, and April of 2021.

You may not qualify if:

  • Age \<18 years
  • Have any other condition which, at the investigator's discretion, is believed may present a safety risk or impact the feasibility of the study or the study results
  • Patients admitted for emergency CABG surgery
  • Unable to provide written informed consent before surgery
  • Patients who would be contra-indicated to HME humidification devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Melanie Moylan

    Auckland University of Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Redmond

CONTACT

+649 921 9999catherine.redmond@aut.ac.nz

Study Design

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

Study Record Dates

First Submitted

February 16, 2021

First Posted

February 23, 2021

Study Start

March 1, 2021

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

March 10, 2021

Record last verified: 2021-03