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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01300845
Other study ID # PHRI 2010-02
Secondary ID
Status Completed
Phase N/A
First received February 18, 2011
Last updated November 19, 2014
Start date March 2011
Est. completion date August 2014

Study information

Verified date February 2014
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Procedure:
Humidification
From randomization, oxygen therapy is humidified
No Humidification
oxygen therapy is never humidified

Locations

Country Name City State
France University Hospital Angers

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

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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