Trial Aiming at Assessing the Effect of Humidification on the Comfort of the Patient Receiving an Oxygen Therapy

Overview

In France, the most used humidifying system during oxygen therapy is a non heated device with weak efficiency and non-proven clinical benefits. This study aims to assess the lack of benefits of non-heated humidification compared to no humidification, as regards to the comfort of the patient receiving oxygen therapy.

Full Title of Study: “Prospective, Randomized, Multi-center Trial Aiming at Assessing the Effect of Humidification on the Comfort of the Patient Receiving an Oxygen Therapy.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2014

Interventions

  • Procedure: Humidification
    • From randomization, oxygen therapy is humidified
  • Procedure: No Humidification
    • oxygen therapy is never humidified

Arms, Groups and Cohorts

  • Active Comparator: Humidification
  • Experimental: No Humidification

Clinical Trial Outcome Measures

Primary Measures

  • A score of comfort assessed with a detailed and specific questionnaire
    • Time Frame: This score is assessed between the sixth and the eighth hour after randomization
    • This score is built from answers brought in a questionnaire including 15 items. Each item can be rated from 0 to 10, allowing to increment a score on 150 points.

Secondary Measures

  • The specific scores of comfort for each items
    • Time Frame: Hour 6-8
  • Observance level for oxygen therapy
    • Time Frame: Hour 6-8
  • Percentage of patients requiring a fibroscopic aspirations during their stay in intensive care unit or USC within the limits of 28 days.
    • Time Frame: Department discharge limited by day 28
  • Percentage of patients requiring an intubation during their stay in intensive care unit or USC within the limits of 28 days.
    • Time Frame: Department discharge limited by day 28
  • Percentage of patients who had an ear, nose and throat infections during their stay in intensive care unit or USC within the limits of 28 days.
    • Time Frame: Department discharge limited by day 28
  • The patients who had a lesion of corneas during their stay in intensive care unit or USC within the limits of 28 days
    • Time Frame: Department discharge limited by day 28
  • The length of stay in intensive care unit or USC
    • Time Frame: Department discharge limited by day 28
  • mortality in intensive care unit or USC during ongoing stay within the limits of 28 days.
    • Time Frame: Department discharge limited by day 28

Participating in This Clinical Trial

Inclusion Criteria

  • Admission in Intensive Care Unit – Oxygen therapy started for less than two hours in ICU Exclusion Criteria:

  • Age under 18 – Pregnancy – Participation in other trials with the same endpoints – absence of registration in french health care system – patient protected by law – tracheotomised or intubated patient – Patient with non invasive ventilation – Oxygen therapy started for more than two hours in ICU – moribund

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Angers
  • Provider of Information About this Clinical Study
    • Sponsor

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