RespirAq Humidifier Usability During Invasive Ventilation

March 8, 2021 updated by: Auckland University of Technology

RespirAq Humidification During Post-operative Invasive Mechanical Ventilation in Scheduled Cardiothoracic Surgical Patients: a Feasibility Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Humidification
Device: RespirAq Humidification
Humidifier

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Auckland University of Technology

Collaborators

Ministry of Business, Innovation and Employment
Waikato District Health Board

Investigators

  • Principal Investigator: Melanie Moylan, Auckland University of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

February 16, 2021

First Submitted That Met QC Criteria

February 18, 2021

First Posted (Actual)

February 23, 2021

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2010-01 (internal number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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