Oxygen Inhalation Therapy Clinical Trial
— OXYREAOfficial title:
Prospective, Randomized, Multi-center Trial Aiming at Assessing the Effect of Humidification on the Comfort of the Patient Receiving an Oxygen Therapy.
Verified date | February 2014 |
Source | University Hospital, Angers |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 356 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
France | University Hospital | Angers |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Angers |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | The specific scores of comfort for each items | Hour 6-8 | No | |
Secondary | Observance level for oxygen therapy | Hour 6-8 | No | |
Secondary | 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 | Yes | |
Secondary | 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 | Yes | |
Secondary | 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 | Yes | |
Secondary | The patients who had a lesion of corneas during their stay in intensive care unit or USC within the limits of 28 days | Department discharge limited by day 28 | Yes | |
Secondary | The length of stay in intensive care unit or USC | Department discharge limited by day 28 | Yes | |
Secondary | mortality in intensive care unit or USC during ongoing stay within the limits of 28 days. | Department discharge limited by day 28 | Yes |
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