NCT01300845CompletedNot Applicable
Prospective, Randomized, Multi-center Trial Aiming at Assessing the Effect of Humidification on the Comfort of the Patient Receiving an Oxygen Therapy.
University Hospital, Angers1 site in 1 country356 target enrollmentStarted: March 1, 2011Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 356
- Locations
- 1
- Primary Endpoint
- A score of comfort assessed with a detailed and specific questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
No Humidification
Experimental
Intervention: No Humidification (Procedure)
Humidification
Active Comparator
Intervention: Humidification (Procedure)
Outcomes
Primary Outcomes
A score of comfort assessed with a detailed and specific questionnaire
Time Frame: 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 Outcomes
- 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 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)
- 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 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)
- Observance level for oxygen therapy(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)
Investigators
Study Sites (1)
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