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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Randomized, Multi-center Trial Aiming at Assessing the Effect of Humidification on the Comfort of the Patient Receiving an Oxygen Therapy.

Conditions
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Oxygen Inhalation Therapy

Intervention / Treatment
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* Procedure: Humidification
* Procedure: No Humidification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Humidification<br> | Procedure: Humidification<br>* From randomization, oxygen therapy is humidified<br>|
| Experimental: No Humidification<br> | Procedure: No Humidification<br>* oxygen therapy is never humidified<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive Care Unit, Oxygen mask, Oxygen cannula, Humidification, Oxygen therapy