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NCT Number: NCT06719258

Evaluation of Gas Humidification Practices in Patients Under Invasive Mechanical Ventilation

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.

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Key information

Conditions

Humidifier Lung Mechanical Fragility Respiratory Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V4G5, Canada

Location status: Recruiting

Location contact

Francois Lellouche

CONTACT

[email protected]

418-656-8711

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 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.

Exclusion criteria

  • 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.

Treatment and study plan

MR850

Device

This humidifier will be used straight away for patients whose intubation is expected to last longer than 24 hours.

FP950

Device

This humidifier will be used straight away for patients whose intubation is expected to last longer than 24 hours.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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).

Secondary outcomes

  1. 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)

    These data will be collected:

    • mechanical ventilation time
    • length of stay in intensive care
    • ventilation pressures
    • use of bronchodilator aerosols.
    • Ambien room air temperature

Study contacts

Contact information is provided by the study sponsor or research team.

François Lellouche

CONTACT

[email protected]

418-656-8711 ext. 3572

Pierre-Alexandre Bouchard

CONTACT

[email protected]

418-656-8711 ext. 2712

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study 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

Acronym: FP950

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 5, 2024
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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