NCT07420673

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
10mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Apr 2026Jun 2027

First Submitted

Initial submission to the registry

February 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

February 12, 2026

Last Update Submit

February 12, 2026

Conditions

Keywords

humidificationPassive humidification

Outcome Measures

Primary Outcomes (2)

  • Expiratory gas temperature

    Measure expiratory gas temperature immediately before the passive humidifier

    H0, up to 60 minutes after inclusion

  • Relationship between body temperature and expiratory temperature.

    Evaluate the relationship between body temperature and expiratory temperature

    H0, up to 60 minutes after inclusion

Secondary Outcomes (1)

  • Estimate expiratory absolute humidity based on measured temperature

    H0, up to 60 minutes after inclusion

Study Arms (3)

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

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

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

Other: Expiratory gases temperature

Interventions

Measure expiratory gas temperature immediately before the passive humidifier in intubated ICU patients and evaluate the relationship between body temperature and expiratory temperature.

Hyperthermic patientHypothermic patientNormothermic patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Intubated patient using a heater and moist exchanger

You may qualify if:

  • Adults (≥18 years)
  • Intubated and mechanically ventilated in the intensive care unite
  • Using passive humidification (Heat and Moisture exchanger)

You may not qualify if:

  • PEEP set \< 12 cmH₂O
  • Inhaled nitric oxide therapy
  • Tracheostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Insitut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval

Québec, Quebec, G1V4G5, Canada

Location

Central Study Contacts

Francois Lellouche, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 19, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations