Evaluation of Gas Humidification Practices in Patients Under Invasive Mechanical Ventilation (FP950)

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Complication; Humidifier Lung; Mechanical Fragility
• Intervention / Treatment: Device: MR850; Device: FP950

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: François Lellouche; Phone Number: 3572 418-656-8711; Email: francois.lellouche@criucpq.ulaval.ca
• Study Contact Backup: Name: Pierre-Alexandre Bouchard; Phone Number: 2712 418-656-8711; Email: pierre-alexandre.bouchard@criucpq.ulaval.ca

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V4G5
      • Recruiting
      • Institut Universitaire de Cardiologie et de Pneumologie de Quebec
      • Contact: Francois Lellouche; Phone Number: 418-656-8711; Email: francois.lellouche@criucpq.ulaval.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All patient in ICU on ventilation will be consider.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MR850; 20 subjects on this heating humidifier (Fisher & Paykel MR850).	Device: MR850; This humidifier will be used straight away for patients whose intubation is expected to last longer than 24 hours.
FP950; 20 subjects on this heating humidifier (Fisher & Paykel FP950).	Device: FP950; This humidifier will be used straight away for patients whose intubation is expected to last longer than 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endotracheal tube occlusion requiring emergency tube change	Under-humidification episodes are defined as follows: - Occurence of endotracheal tube occlusion requiring emergency tube change	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	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	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	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).	At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)

Collaborators and Investigators

• Sponsor: Laval University

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2022-3714

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No