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

Oxygen Inhalation Therapy Clinical Trial

— OXYREA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01300845
• Other study ID #: PHRI 2010-02
• Status: Completed
• Phase: N/A
• First received: February 18, 2011
• Last updated: November 19, 2014
• Start date: March 2011
• Est. completion date: August 2014

Study information

• Verified date: February 2014
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Oxygen Inhalation Therapy

Intervention

Procedure:
• Humidification
From randomization, oxygen therapy is humidified
• No Humidification
oxygen therapy is never humidified

Locations

Country	Name	City	State
France	University Hospital	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	This score is assessed between the sixth and the eighth hour after randomization	No
Secondary	The specific scores of comfort for each items		Hour 6-8	No
Secondary	Observance level for oxygen therapy		Hour 6-8	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	The length of stay in intensive care unit or USC		Department discharge limited by day 28	Yes
Secondary	mortality in intensive care unit or USC during ongoing stay within the limits of 28 days.		Department discharge limited by day 28	Yes