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

University Hospital, Angers

Status: Completed

Conditions: Oxygen Inhalation Therapy

Treatments: Procedure: No Humidification; Procedure: Humidification

Study type: Interventional

Funder types: Other

Identifiers

NCT01300845

PHRI 2010-02

Details and patient eligibility

About

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.

Enrollment: 356 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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356 participants in 2 patient groups

Humidification

Active Comparator group

Treatment:

Procedure: Humidification

No Humidification

Experimental group

Treatment:

Procedure: No Humidification