Mechanical VentilationNCT04765878
RespirAq Humidifier Usability During Invasive Ventilation
A study testing RespirAq Humidification in people with Mechanical Ventilation, run by Auckland University of Technology.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- RespirAq Humidification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Mechanical Ventilation
- Being tested
- RespirAq Humidification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RespirAq HumidificationDevice
Humidifier
| Study group | Role | What they receive |
|---|---|---|
| Humidification | Experimental | Not described Receives: Device: RespirAq Humidification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature
Meet ISO standard
Measured: max 24 hours
Humidity
Meet ISO standard
Measured: max 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study startMar 2021 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auckland University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Business, Innovation and Employment, Waikato District Health Board
- Responsible party
- Sponsor
- Investigators
- Melanie Moylan, Principal investigator, Auckland University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765878
- Sponsor's protocol ID
- 2010-01
- Status last verified
- Mar 2021
- First submitted
- 16 Feb 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RespirAq Humidification During Post-operative Invasive Mechanical Ventilation in Scheduled Cardiothoracic Surgical Patients: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04765878
- Acronym / sponsor ID
- 2010-01
- Conditions
- Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Auckland University of TechnologyUniversity, hospital or other
- Collaborators
- Ministry of Business, Innovation and Employment, Waikato District Health Board
- Study start
- Mar 2021 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Humidification | Experimental | Device: RespirAq Humidification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RespirAq HumidificationHumidifier | Device | Humidification |
Primary outcome
Temperature
Time frame: max 24 hours
Meet ISO standard
Humidity
Time frame: max 24 hours
Meet ISO standard
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Moylan principal investigator
Auckland University of Technology
Questions about this trial
What is this clinical trial studying?
A study testing RespirAq Humidification in people with Mechanical Ventilation, run by Auckland University of Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine Redmond (+649 921 9999 ext. 9386, catherine.redmond@aut.ac.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature (time frame: max 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.