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

November 19, 2014 updated by: University Hospital, Angers

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

356

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No Humidification
Procedure: No Humidification
oxygen therapy is never humidified
Active Comparator: Humidification
Procedure: Humidification
From randomization, oxygen therapy is humidified

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
This score is assessed between the sixth and the eighth hour after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
The specific scores of comfort for each items
Time Frame: Hour 6-8
Hour 6-8
Observance level for oxygen therapy
Time Frame: Hour 6-8
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.
Time Frame: Department discharge limited by day 28
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.
Time Frame: Department discharge limited by day 28
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.
Time Frame: Department discharge limited by day 28
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
Time Frame: Department discharge limited by day 28
Department discharge limited by day 28
The length of stay in intensive care unit or USC
Time Frame: Department discharge limited by day 28
Department discharge limited by day 28
mortality in intensive care unit or USC during ongoing stay within the limits of 28 days.
Time Frame: Department discharge limited by day 28
Department discharge limited by day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

February 18, 2011

First Submitted That Met QC Criteria

February 22, 2011

First Posted (Estimate)

February 23, 2011

Study Record Updates

Last Update Posted (Estimate)

November 20, 2014

Last Update Submitted That Met QC Criteria

November 19, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRI 2010-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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