- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07420673
Measurement of Expiratory Gas Temperature in Intubated Patients to Estimate Expiratory Absolute Humidity
February 12, 2026 updated by: François Lellouche, Laval University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Francois Lellouche, MD, PhD
- Phone Number: 3572 1 418-656-8711
- Email: francois.lellouche@criucpq.ulaval.ca
Study Locations
-
-
Quebec
-
Québec, Quebec, Canada, G1V4G5
- Insitut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Intubated patient using a heater and moist exchanger
Description
Inclusion Criteria:
- Adults (≥18 years)
- Intubated and mechanically ventilated in the intensive care unite
- Using passive humidification (Heat and Moisture exchanger)
Exclusion Criteria:
- PEEP set < 12 cmH₂O
- Inhaled nitric oxide therapy
- Tracheostomy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
Measure expiratory gas temperature immediately before the passive humidifier in intubated ICU patients and evaluate the relationship between body temperature and expiratory temperature.
|
|
Hypothermic patient
Hypothermic patient under mechanical ventilation with passive humification (heat and moisture exchanger) with body temperature < 36.0
Celsius degrees
|
Measure expiratory gas temperature immediately before the passive humidifier in intubated ICU patients and evaluate the relationship between body temperature and expiratory temperature.
|
|
Hyperthermic patient
Hyperthermic patient under mechanical ventilation with passive humification (heat and moisture exchanger) with body temperature > 38.0 Celsius degrees
|
Measure expiratory gas temperature immediately before the passive humidifier in intubated ICU patients and evaluate the relationship between body temperature and expiratory temperature.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Expiratory gas temperature
Time Frame: H0, up to 60 minutes after inclusion
|
Measure expiratory gas temperature immediately before the passive humidifier
|
H0, up to 60 minutes after inclusion
|
|
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
|
H0, up to 60 minutes after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Estimate expiratory absolute humidity based on measured temperature
Time Frame: H0, up to 60 minutes after inclusion
|
H0, up to 60 minutes after inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
June 1, 2027
Study Registration Dates
First Submitted
February 12, 2026
First Submitted That Met QC Criteria
February 12, 2026
First Posted (Actual)
February 19, 2026
Study Record Updates
Last Update Posted (Actual)
February 19, 2026
Last Update Submitted That Met QC Criteria
February 12, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2026-4543
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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