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

This study is currently recruiting participants.
Verified February 2014 by University Hospital, Angers
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01300845
First received: February 18, 2011
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Oxygen Inhalation Therapy
Procedure: Humidification
Procedure: No Humidification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Prospective, Randomized, Multi-center Trial Aiming at Assessing the Effect of Humidification on the Comfort of the Patient Receiving an Oxygen Therapy.

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • The specific scores of comfort for each items [ Time Frame: Hour 6-8 ] [ Designated as safety issue: No ]
  • Observance level for oxygen therapy [ Time Frame: Hour 6-8 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • The length of stay in intensive care unit or USC [ Time Frame: Department discharge limited by day 28 ] [ Designated as safety issue: Yes ]
  • mortality in intensive care unit or USC during ongoing stay within the limits of 28 days. [ Time Frame: Department discharge limited by day 28 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 350
Study Start Date: March 2011
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Humidification Procedure: Humidification
From randomization, oxygen therapy is humidified
Experimental: No Humidification Procedure: No Humidification
oxygen therapy is never humidified

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300845

Contacts
Contact: Laurent POIROUX 0033(0)241355864 lapoiroux@chu-angers.fr

Locations
France
University Hospital Recruiting
Angers, France, 49933
Contact: Laurent POIROUX    0033(0)241355864    lapoiroux@chu-angers.fr   
Sponsors and Collaborators
University Hospital, Angers
  More Information

No publications provided

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01300845     History of Changes
Other Study ID Numbers: PHRI 2010-02
Study First Received: February 18, 2011
Last Updated: February 20, 2014
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Angers:
Oxygen mask
Oxygen cannula
Humidification
Oxygen therapy
Intensive Care Unit

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014