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

Primary Purpose

Oxygen Inhalation Therapy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Humidification
No Humidification
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oxygen Inhalation Therapy focused on measuring Oxygen mask, Oxygen cannula, Humidification, Oxygen therapy, Intensive Care Unit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Humidification

No Humidification

Arm Description

Outcomes

Primary Outcome Measures

A score of comfort assessed with a detailed and specific questionnaire
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

The specific scores of comfort for each items
Observance level for oxygen therapy
Percentage of patients requiring a fibroscopic aspirations during their stay in intensive care unit or USC within the limits of 28 days.
Percentage of patients requiring an intubation during their stay in intensive care unit or USC within the limits of 28 days.
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.
The patients who had a lesion of corneas during their stay in intensive care unit or USC within the limits of 28 days
The length of stay in intensive care unit or USC
mortality in intensive care unit or USC during ongoing stay within the limits of 28 days.

Full Information

First Posted
February 18, 2011
Last Updated
November 19, 2014
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT01300845
Brief Title
Trial Aiming at Assessing the Effect of Humidification on the Comfort of the Patient Receiving an Oxygen Therapy
Acronym
OXYREA
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 Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxygen Inhalation Therapy
Keywords
Oxygen mask, Oxygen cannula, Humidification, Oxygen therapy, Intensive Care Unit

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
356 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Humidification
Arm Type
Active Comparator
Arm Title
No Humidification
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Humidification
Intervention Description
From randomization, oxygen therapy is humidified
Intervention Type
Procedure
Intervention Name(s)
No Humidification
Intervention Description
oxygen therapy is never humidified
Primary Outcome Measure Information:
Title
A score of comfort assessed with a detailed and specific questionnaire
Description
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.
Time Frame
This score is assessed between the sixth and the eighth hour after randomization
Secondary Outcome Measure Information:
Title
The specific scores of comfort for each items
Time Frame
Hour 6-8
Title
Observance level for oxygen therapy
Time Frame
Hour 6-8
Title
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
Title
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
Title
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
Title
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
Title
The length of stay in intensive care unit or USC
Time Frame
Department discharge limited by day 28
Title
mortality in intensive care unit or USC during ongoing stay within the limits of 28 days.
Time Frame
Department discharge limited by day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Hospital
City
Angers
ZIP/Postal Code
49933
Country
France

12. IPD Sharing Statement

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

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