RespirAq Humidifier Usability During Invasive Ventilation | NCT04765878

Studies
RespirAq Humidifier Usability During Invasive Ventilation

NCT04765878

Sponsor

Auckland University of Technology

Status

Unknown status

Last Update Posted

Mar 10, 2021Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Mechanical Ventilation

Interventions

RespirAq Humidification

Countries

Not provided

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 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2021Estimated

Primary Completion Date

Apr 2021Estimated

Completion Date

Apr 2021Estimated

First Submitted Date

Feb 16, 2021

First Submission Date that Met QC Criteria

Feb 18, 2021

First Posted Date

Feb 23, 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 8, 2021

Last Update Posted Date

Mar 10, 2021Actual

Name	Class
Ministry of Business, Innovation and Employment	UNKNOWN
Waikato District Health Board	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

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.

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Humidification	Experimental		Device: RespirAq Humidification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RespirAq Humidification	Device	Humidifier	Humidification

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Temperature	Meet ISO standard	max 24 hours
Humidity	Meet ISO standard	max 24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

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

Name	Role	Phone	Extension	Email
Catherine Redmond	Contact	+649 921 9999	9386	catherine.redmond@aut.ac.nz

Overall Officials

Name	Affiliation	Role
Melanie Moylan	Auckland University of Technology	Principal Investigator

Locations

Not provided