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

Not Applicable

Completed

• Conditions: Oxygen Inhalation Therapy
• Interventions: Procedure: No Humidification; Procedure: Humidification

• Registration Number: NCT01300845
• Lead Sponsor: University Hospital, Angers

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-18
• Study First Submitted QC: 2011-02-22
• Study First Posted: 2011-02-23
• Study Start: 2011-03
• Status Verified: 2014-02
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2014-11-19
• Last Update Posted: 2014-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Humidification	No Humidification	-
Humidification	Humidification	-

Primary Outcome Measures

Name	Time	Method
A score of comfort assessed with a detailed and specific questionnaire	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 Outcome Measures

Name	Time	Method
Observance level for oxygen therapy	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.	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.	Department discharge limited by day 28
mortality in intensive care unit or USC during ongoing stay within the limits of 28 days.	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.	Department discharge limited by day 28
The specific scores of comfort for each items	Hour 6-8
The patients who had a lesion of corneas during their stay in intensive care unit or USC within the limits of 28 days	Department discharge limited by day 28
The length of stay in intensive care unit or USC	Department discharge limited by day 28

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Angers, France