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NCT Number: NCT01300845

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.

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Key information

Conditions

Oxygen Inhalation Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Angers, 49933, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Humidification

Procedure

From randomization, oxygen therapy is humidified

No Humidification

Procedure

oxygen therapy is never humidified

Primary outcomes

  1. 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

  1. The specific scores of comfort for each items

    Time frame: Hour 6-8

  2. Observance level for oxygen therapy

    Time frame: Hour 6-8

  3. 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

  4. 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

  5. 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

  6. 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

  7. The length of stay in intensive care unit or USC

    Time frame: Department discharge limited by day 28

  8. mortality in intensive care unit or USC during ongoing stay within the limits of 28 days.

    Time frame: Department discharge limited by day 28

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: OXYREA

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 23, 2011
Registry last updated
Nov 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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