Oxygen Inhalation TherapyOXYREANCT01300845
Trial Aiming at Assessing the Effect of Humidification on the Comfort of the Patient Receiving an Oxygen Therapy
A study testing Humidification and No Humidification in people with Oxygen Inhalation Therapy, run by University Hospital, Angers at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygen Inhalation Therapy
- What is being tested?
- Humidification and No Humidification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission in Intensive Care Unit
- Oxygen therapy started for less than two hours in ICU
Who cannot join
- 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
Show all 9Show fewer
- Patient with non invasive ventilation
- Oxygen therapy started for more than two hours in ICU
- moribund
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Multi-center 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.
- Conditions
- Oxygen Inhalation Therapy
- Being tested
- Humidification, No Humidification
- Keywords
- Oxygen mask, Oxygen cannula, Humidification, Oxygen therapy, Intensive Care Unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HumidificationProcedure or surgery
From randomization, oxygen therapy is humidified
No HumidificationProcedure or surgery
oxygen therapy is never humidified
| Study group | Role | What they receive |
|---|---|---|
| Humidification | Active comparator | Not described Receives: Procedure: Humidification |
| No Humidification | Experimental | Not described Receives: Procedure: No Humidification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This score is assessed between the sixth and the eighth hour after randomization
Secondary outcomes (8)
The specific scores of comfort for each items
Measured: Hour 6-8
Observance level for oxygen therapy
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Department discharge limited by day 28
The patients who had a lesion of corneas during their stay in intensive care unit or USC within the limits of 28 days
Measured: Department discharge limited by day 28
The length of stay in intensive care unit or USC
Measured: Department discharge limited by day 28
mortality in intensive care unit or USC during ongoing stay within the limits of 28 days.
Measured: Department discharge limited by day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen Inhalation TherapyStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300845
- Sponsor's protocol ID
- PHRI 2010-02
- Acronym
- OXYREA
- Status last verified
- Feb 2014
- First submitted
- 18 Feb 2011
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Multi-center Trial Aiming at Assessing the Effect of Humidification on the Comfort of the Patient Receiving an Oxygen Therapy.
- ClinicalTrials.gov ID
- NCT01300845
- Acronym / sponsor ID
- OXYREA / PHRI 2010-02
- Conditions
- Oxygen Inhalation Therapy
- Keywords
- Oxygen mask, Oxygen cannula, Humidification, Oxygen therapy, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Mar 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 23 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Humidification | Active comparator | Procedure: Humidification |
| No Humidification | Experimental | Procedure: No Humidification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admission in Intensive Care Unit
- Oxygen therapy started for less than two hours in ICU
Key exclusion criteria (9 listed)
- Age under 18
- Pregnancy
- Participation in other trials with the same endpoints
- absence of registration in french health care system
- patient protected by law
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HumidificationFrom randomization, oxygen therapy is humidified | Procedure or surgery | Humidification |
| No Humidificationoxygen therapy is never humidified | Procedure or surgery | No Humidification |
Primary outcome
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.
8 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.
Time frame: 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.
Time frame: 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.
Time frame: Department discharge limited by day 28
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
The length of stay in intensive care unit or USC
Time frame: Department discharge limited by day 28
mortality in intensive care unit or USC during ongoing stay within the limits of 28 days.
Time frame: Department discharge limited by day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humidification and No Humidification in people with Oxygen Inhalation Therapy, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2014.