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

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ClinicalTrials.gov Identifier: NCT01300845
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : November 20, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Oxygen Inhalation Therapy Procedure: Humidification Procedure: No Humidification Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prospective, Randomized, Multi-center Trial Aiming at Assessing the Effect of Humidification on the Comfort of the Patient Receiving an Oxygen Therapy.
Study Start Date : March 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Humidification Procedure: Humidification
From randomization, oxygen therapy is humidified
Experimental: No Humidification Procedure: No Humidification
oxygen therapy is never humidified



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. The specific scores of comfort for each items [ Time Frame: Hour 6-8 ]
  2. Observance level for oxygen therapy [ Time Frame: Hour 6-8 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. The length of stay in intensive care unit or USC [ Time Frame: Department discharge limited by day 28 ]
  8. mortality in intensive care unit or USC during ongoing stay within the limits of 28 days. [ Time Frame: Department discharge limited by day 28 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01300845


Locations
France
University Hospital
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01300845     History of Changes
Other Study ID Numbers: PHRI 2010-02
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: February 2014

Keywords provided by University Hospital, Angers:
Oxygen mask
Oxygen cannula
Humidification
Oxygen therapy
Intensive Care Unit