Oxygen Inhalation Therapy
Conditions
Keywords
Oxygen mask, Oxygen cannula, Humidification, Oxygen therapy, Intensive Care Unit
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.
Interventions
PROCEDUREHumidification
From randomization, oxygen therapy is humidified
PROCEDURENo Humidification
oxygen therapy is never humidified
Sponsors
University Hospital, Angers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A score of comfort assessed with a detailed and specific questionnaire | 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
| Measure | Time frame |
|---|---|
| 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 |
| The specific scores of comfort for each items | Hour 6-8 |
| 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 |
| The length of stay in intensive care unit or USC | Department discharge limited by day 28 |
| mortality in intensive care unit or USC during ongoing stay 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 |
Countries
France
Outcome results
None listed