Humidifier LungFP950NCT06719258
Evaluation of Gas Humidification Practices in Patients Under Invasive Mechanical Ventilation
An observational study of Humidifier Lung and Mechanical Fragility, run by Laval University at 1 site in Canada.
Trial summary
When mechanical ventilation is initiated, a humidification method should be chosen. There is two methods: heat and humidity exchanger filters or heated humidity. The second method is recognized to be more efficient, but many external factors can influence its performance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Humidifier Lung, Mechanical Fragility, Respiratory Complication
- What is being tested?
- MR850 and FP950
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 20 Sep 2024to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: All patient in ICU on ventilation will be consider.
Who may be able to join
- ≥ 18 years old
- Admitted to intensive care
- Under invasive mechanical ventilation with the usual indications for the use of a heated humidifier (prolonged invasive mechanical ventilation and / or protective ventilation requiring high respiratory rates.
Who cannot join
- Mechanical venitilation immediately after surgery (<24h)
- Imminent extubation or planned intubation of very short duration (<24h)
- Enrolled in the SAVE-ICU study in the group receiving volatile agents with the AnaConDa system.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V4G5
About this study
Official title: Evaluation of Gas Humidification Practices in Patients Under Invasive Mechanical Ventilation: Benefit of the F & P950 Heated Humidifier: Comparison With the MR 850 on Clinical Events of Under-humidification
When mechanical ventilation is initiated, a humidification method should be chosen. There is two methods: heat and humidity exchanger filters or heated humidity. The second method is recognized to be more efficient, but many external factors can influence its performance. Insufficient humidity results in observable problems, such as difficult management of respiratory secretions.
The study compare two heated humidifiers already used in ICU.
Data will be collected retrospectively from June 1, 2021.
- Being tested
- MR850, FP950
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR850Device
This humidifier will be used straight away for patients whose intubation is expected to last longer than 24 hours.
FP950Device
This humidifier will be used straight away for patients whose intubation is expected to last longer than 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| MR850 | 20 subjects on this heating humidifier (Fisher \& Paykel MR850). Receives: Device: MR850 | |
| FP950 | 20 subjects on this heating humidifier (Fisher \& Paykel FP950). Receives: Device: FP950 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotracheal tube occlusion requiring emergency tube change
Under-humidification episodes are defined as follows:
- Occurence of endotracheal tube occlusion requiring emergency tube change
Measured: At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)
Bronchoscopy
Under-humidification episodes are defined as follows:
- Occurence of performing a bronchoscopy for a suspected sub-occlusion (thick or sticky secretions), and the total number of bronchoscopies performed per patient
Measured: At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)
Tracheal saline instillations
Under-humidification episodes are defined as follows:
- Occurence of tracheal saline instillations due to sticky secretions or suspected endotracheal tube sub-occlusion
Measured: At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)
Thick secretions
Under-humidification episodes are defined as follows:
- Occurence of tracheal secretions describe at thick secretions (rated at 5 on the secretions scale used at the hospital) or "sticky secretions" if specified
Measured: At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)
Change humidifier settings
Under-humidification episodes are defined as follows:
- The number of operations required to change humidifier settings if the plate temperature is below 62 degrees Celcius (with the MR850).
Measured: At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)
Secondary outcomes (1)
Other elements that may be influenced by the quality of the humidification used during mechanical ventilation
These data will be collected:
- mechanical ventilation time
- length of stay in intensive care
- ventilation pressures
- use of bronchodilator aerosols.
- Ambien room air temperature
Measured: At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start20 Sep 2024
- Primary completion29 Jun 2026
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humidifier LungStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, François Lellouche, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719258
- Sponsor's protocol ID
- 2022-3714
- Acronym
- FP950
- Status last verified
- Nov 2026
- First submitted
- 20 Nov 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gas Humidification Practices in Patients Under Invasive Mechanical Ventilation: Benefit of the F & P950 Heated Humidifier: Comparison With the MR 850 on Clinical Events of Under-humidification
- ClinicalTrials.gov ID
- NCT06719258
- Acronym / sponsor ID
- FP950 / 2022-3714
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- Jul 2027 (estimated)
- First posted
- 5 Dec 2024 (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.
When mechanical ventilation is initiated, a humidification method should be chosen. There is two methods: heat and humidity exchanger filters or heated humidity. The second method is recognized to be more efficient, but many external factors can influence its performance. Insufficient humidity results in observable problems, such as difficult management of respiratory secretions.
The study compare two heated humidifiers already used in ICU.
Data will be collected retrospectively from June 1, 2021.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MR850 | – | Device: MR85020 subjects on this heating humidifier (Fisher \& Paykel MR850). |
| FP950 | – | Device: FP95020 subjects on this heating humidifier (Fisher \& Paykel FP950). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patient in ICU on ventilation will be consider.
Key inclusion criteria (3 listed)
- ≥ 18 years old
- Admitted to intensive care
- Under invasive mechanical ventilation with the usual indications for the use of a heated humidifier (prolonged invasive mechanical ventilation and / or protective ventilation requiring high respiratory rates.
Key exclusion criteria (3 listed)
- Mechanical venitilation immediately after surgery (<24h)
- Imminent extubation or planned intubation of very short duration (<24h)
- Enrolled in the SAVE-ICU study in the group receiving volatile agents with the AnaConDa system.
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 |
|---|---|---|
| MR850This humidifier will be used straight away for patients whose intubation is expected to last longer than 24 hours. | Device | MR850 |
| FP950This humidifier will be used straight away for patients whose intubation is expected to last longer than 24 hours. | Device | FP950 |
Primary outcome
Endotracheal tube occlusion requiring emergency tube change
Time frame: At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)
Under-humidification episodes are defined as follows: - Occurence of endotracheal tube occlusion requiring emergency tube change
Bronchoscopy
Time frame: At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)
Under-humidification episodes are defined as follows: - Occurence of performing a bronchoscopy for a suspected sub-occlusion (thick or sticky secretions), and the total number of bronchoscopies performed per patient
Tracheal saline instillations
Time frame: At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)
Under-humidification episodes are defined as follows: - Occurence of tracheal saline instillations due to sticky secretions or suspected endotracheal tube sub-occlusion
Thick secretions
Time frame: At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)
Under-humidification episodes are defined as follows: - Occurence of tracheal secretions describe at thick secretions (rated at 5 on the secretions scale used at the hospital) or "sticky secretions" if specified
Change humidifier settings
Time frame: At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)
Under-humidification episodes are defined as follows: - The number of operations required to change humidifier settings if the plate temperature is below 62 degrees Celcius (with the MR850).
1 secondary outcome
Other elements that may be influenced by the quality of the humidification used during mechanical ventilation
Time frame: At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Humidifier Lung and Mechanical Fragility, run by Laval University at 1 site in Canada.
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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endotracheal tube occlusion requiring emergency tube change (time frame: At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)). The study lists 5 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 5 Nov 2026.