NCT06719258

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
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 Progress92%
Sep 2024Jul 2026

Study Start

First participant enrolled

September 20, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

1.2 years

First QC Date

November 20, 2024

Last Update Submit

August 27, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

  • Other elements that may be influenced by the quality of the humidification used during mechanical ventilation

    At the end of the mechanical ventilation period or at 21 days ( the first of the 2 occurred)

Study Arms (2)

MR850

20 subjects on this heating humidifier (Fisher \& Paykel MR850).

Device: MR850

FP950

20 subjects on this heating humidifier (Fisher \& Paykel FP950).

Device: FP950

Interventions

MR850DEVICE

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

MR850
FP950DEVICE

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

FP950

Eligibility Criteria

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

All patient in ICU on ventilation will be consider.

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V4G5, Canada

RECRUITING

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

November 20, 2024

First Posted

December 5, 2024

Study Start

September 20, 2024

Primary Completion

December 1, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

August 28, 2025

Record last verified: 2025-08

Locations