Trial Aiming at Assessing the Effect of Humidification on the Comfort of the Patient Receiving an Oxygen Therapy
OXYREA
Prospective, Randomized, Multi-center Trial Aiming at Assessing the Effect of Humidification on the Comfort of the Patient Receiving an Oxygen Therapy.
1 other identifier
interventional
356
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2011
Longer than P75 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
February 18, 2011
CompletedFirst Posted
Study publicly available on registry
February 23, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedNovember 20, 2014
February 1, 2014
3.4 years
February 18, 2011
November 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
This score is assessed between the sixth and the eighth hour after randomization
Secondary Outcomes (8)
The specific scores of comfort for each items
Hour 6-8
Observance level for oxygen therapy
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.
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.
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.
Department discharge limited by day 28
- +3 more secondary outcomes
Study Arms (2)
Humidification
ACTIVE COMPARATORNo Humidification
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Admission in Intensive Care Unit
- Oxygen therapy started for less than two hours in ICU
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Angers, 49933, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2011
First Posted
February 23, 2011
Study Start
March 1, 2011
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
November 20, 2014
Record last verified: 2014-02