Mechanical Ventilator CareNCT07420673
Measurement of Expiratory Gas Temperature in Intubated Patients to Estimate Expiratory Absolute Humidity
An observational study of Mechanical Ventilator Care, run by Laval University at 1 site in Canada.
Trial summary
Adequate humidification is essential for intubated patients because dry medical gases can cause thick secretions and dangerous endotracheal tube blockages. A clear correlation exists between exhaled and inhaled humidity delivered by heat and moisture exchanger. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilator Care
- What is being tested?
- Expiratory gases temperature
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 25 May 2026to Jun 2028
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Intubated patient using a heater and moist exchanger
Who may be able to join
- Adults (≥18 years)
- Intubated and mechanically ventilated in the intensive care unite
- Using passive humidification (Heat and Moisture exchanger)
Who cannot join
- PEEP set < 12 cmH₂O
- Inhaled nitric oxide therapy
- Tracheostomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Insitut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
Québec, Quebec, G1V4G5
Francois Lellouche Principal Investigator, 418-656-8711 ext. 3579, francois.lellouche@criucpq.ulaval.ca
About this study
Adequate humidification is essential for intubated patients because dry medical gases can cause thick secretions and dangerous endotracheal tube blockages. A clear correlation exists between exhaled and inhaled humidity delivered by heat and moisture exchanger. The objective of this study is to measure the temperature of exhaled gases in intubated patients in order to accurately calculate the absolute humidity during the expiratory phase. These data will allow for a more accurate reproduction of real clinical conditions during bench testing and will improve the assessment of heat and moisture exchanger performance device evaluation.
Read the detailed description
Previous clinical studies suggest that real expiratory humidity in intubated patients is close to 35 mg H₂O/L, with expiratory temperatures around 32-33 °C or slightly lower. However, data are limited, heterogeneous, and often derived from anesthetized patients. Therefore, accurate measurement of expiratory temperature in intensive care patients under normothermia and across varying body temperatures is necessary to define realistic simulation standards and ensure reliable heat and moisture exchanger performance evaluation on a bench. A relationship between expiratory gases temperature and expiratory humidity exist.
- Conditions
- Mechanical Ventilator Care
- Being tested
- Expiratory gases temperature
- Keywords
- humidification, Passive humidification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expiratory gases temperatureOther
Measure expiratory gas temperature immediately before the passive humidifier in intubated ICU patients and evaluate the relationship between body temperature and expiratory temperature.
| Study group | Role | What they receive |
|---|---|---|
| Normothermic patient | Normothermic patient under mechanical ventilation with passive humification (heat and moisture exchanger) with body temperature between 36.0 and 38.0 Celsius degrees Receives: Other: Expiratory gases temperature | |
| Hypothermic patient | Hypothermic patient under mechanical ventilation with passive humification (heat and moisture exchanger) with body temperature < 36.0 Celsius degrees Receives: Other: Expiratory gases temperature | |
| Hyperthermic patient | Hyperthermic patient under mechanical ventilation with passive humification (heat and moisture exchanger) with body temperature > 38.0 Celsius degrees Receives: Other: Expiratory gases temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expiratory gas temperature
Measure expiratory gas temperature immediately before the passive humidifier
Measured: H0, up to 60 minutes after inclusion
Relationship between body temperature and expiratory temperature.
Evaluate the relationship between body temperature and expiratory temperature
Measured: H0, up to 60 minutes after inclusion
Secondary outcomes (1)
Estimate expiratory absolute humidity based on measured temperature
Measured: H0, up to 60 minutes after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start25 May 2026
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilator CareStudies 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
- Prospective
- Enrolment
- 70 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
- NCT07420673
- Sponsor's protocol ID
- 2026-4543
- Status last verified
- Nov 2026
- First submitted
- 12 Feb 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- Measurement of Expiratory Gas Temperature in Intubated Patients to Estimate Expiratory Absolute Humidity
- ClinicalTrials.gov ID
- NCT07420673
- Acronym / sponsor ID
- 2026-4543
- Conditions
- Mechanical Ventilator Care
- Keywords
- humidification, Passive humidification
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 25 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 19 Feb 2026 (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.
Adequate humidification is essential for intubated patients because dry medical gases can cause thick secretions and dangerous endotracheal tube blockages. A clear correlation exists between exhaled and inhaled humidity delivered by heat and moisture exchanger. The objective of this study is to measure the temperature of exhaled gases in intubated patients in order to accurately calculate the absolute humidity during the expiratory phase. These data will allow for a more accurate reproduction of real clinical conditions during bench testing and will improve the assessment of heat and moisture exchanger performance device evaluation.
Detailed description
Previous clinical studies suggest that real expiratory humidity in intubated patients is close to 35 mg H₂O/L, with expiratory temperatures around 32-33 °C or slightly lower. However, data are limited, heterogeneous, and often derived from anesthetized patients. Therefore, accurate measurement of expiratory temperature in intensive care patients under normothermia and across varying body temperatures is necessary to define realistic simulation standards and ensure reliable heat and moisture exchanger performance evaluation on a bench. A relationship between expiratory gases temperature and expiratory humidity exist.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normothermic patient | – | Other: Expiratory gases temperatureNormothermic patient under mechanical ventilation with passive humification (heat and moisture exchanger) with body temperature between 36.0 and 38.0 Celsius degrees |
| Hypothermic patient | – | Other: Expiratory gases temperatureHypothermic patient under mechanical ventilation with passive humification (heat and moisture exchanger) with body temperature < 36.0 Celsius degrees |
| Hyperthermic patient | – | Other: Expiratory gases temperatureHyperthermic patient under mechanical ventilation with passive humification (heat and moisture exchanger) with body temperature > 38.0 Celsius degrees |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intubated patient using a heater and moist exchanger
Key inclusion criteria (3 listed)
- Adults (≥18 years)
- Intubated and mechanically ventilated in the intensive care unite
- Using passive humidification (Heat and Moisture exchanger)
Key exclusion criteria (3 listed)
- PEEP set < 12 cmH₂O
- Inhaled nitric oxide therapy
- Tracheostomy
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 |
|---|---|---|
| Expiratory gases temperatureMeasure expiratory gas temperature immediately before the passive humidifier in intubated ICU patients and evaluate the relationship between body temperature and expiratory temperature. | Other | Hyperthermic patient, Hypothermic patient, Normothermic patient |
Primary outcome
Expiratory gas temperature
Time frame: H0, up to 60 minutes after inclusion
Measure expiratory gas temperature immediately before the passive humidifier
Relationship between body temperature and expiratory temperature.
Time frame: H0, up to 60 minutes after inclusion
Evaluate the relationship between body temperature and expiratory temperature
1 secondary outcome
Estimate expiratory absolute humidity based on measured temperature
Time frame: H0, up to 60 minutes after inclusion
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.
- Individual participant dataSharing planned: No
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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.
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 Mechanical Ventilator Care, 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: looking for participants now, 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?
Contact Francois Lellouche, MD, PhD (1 418-656-8711 ext. 3572, francois.lellouche@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expiratory gas temperature (time frame: H0, up to 60 minutes after inclusion). 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 5 Nov 2026.