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

University Hospital, Angers356 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

356

Conditions

Oxygen Inhalation Therapy

Interventions

HumidificationPROCEDURE

From randomization, oxygen therapy is humidified

No HumidificationPROCEDURE

oxygen therapy is never humidified

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital

Angers, France

Outcomes

Primary Outcomes

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.

Time frame: This score is assessed between the sixth and the eighth hour after randomization

Secondary Outcomes

The specific scores of comfort for each items

Time frame: Hour 6-8

Observance level for oxygen therapy

Time frame: 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.