RespirAq Humidifier Usability During Invasive Ventilation

Auckland University of Technology

Status: Unknown

Conditions: Mechanical Ventilation

Treatments: Device: RespirAq Humidification

Study type: Interventional

Funder types: Other

Identifiers

NCT04765878

2010-01

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Humidification

Experimental group

Treatment:

Device: RespirAq Humidification