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NCT04765878 Clinical Trial

RespirAq Humidifier Usability During Invasive Ventilation

Mechanical Ventilation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04765878
Other study ID # 2010-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2021
Est. completion date April 2021

Study information
Verified date March 2021
Source Auckland University of Technology
Contact Catherine Redmond
Phone +649 921 9999
Email catherine.redmond@aut.ac.nz
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date April 2021
Est. primary completion date April 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• RespirAq Humidification
Humidifier

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Auckland University of Technology Ministry of Business, Innovation and Employment, Waikato District Health Board

Outcome
Type Measure Description Time frame Safety issue
Primary Temperature Meet ISO standard max 24 hours
Primary Humidity Meet ISO standard max 24 hours
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