Status:
COMPLETED
NOWOX Oxygen Therapy Monitoring Device
Lead Sponsor:
Air Liquide SA
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the duration of oxygen use recorded by the NOWOX, under usual conditions of daily living, in patients with chronic obstructive respiratory disease requiring ox...
Detailed Description
Long Term Oxygen Therapy (LTOT) is one of the main non pharmacologic treatments for patients with severe lung disease. This continuous or sub-continuous oxygen supplementation is generally introduced ...
Eligibility Criteria
Inclusion
- Male or female patient aged ≥ 18 years and ≤ 75 years,
- Having a documented diagnosis of moderately severe to severe chronic obstructive respiratory disease
- Hospitalised or out-patient requiring transient or long term oxygen therapy,
- Able to be weaned from oxygen for several consecutive minutes (around 30 minutes, SpO2 at rest on room air should not drop \< 85%),
- Able to read
- Willing and able to complete the requirements of this study including providing his/her signature for the written informed consent.
Exclusion
- Clinically unstable patient,
- Any contraindication to perform a light cycling exercise, according to the 2003 ATS/ACCP guidelines
- Tracheostomy,
- Nasal obstruction or acute rhinitis occurring in the week prior to selection,
- For female patient:
- Pregnant,
- Positive urinary pregnancy test
- Lactating mother or lack of efficient contraception
- Clinically significant or uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, autoimmune, neurological or psychiatric disorders which may interfere with the study procedures,
- Known allergic reactions to medical material compounds used in the study
- Drug abuse or psychic disorders
- Legal status which prohibits informed consent,
- Participation in any interventional clinical trial within 30 days prior to selection.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00800072
Start Date
November 1 2008
End Date
February 1 2010
Last Update
February 27 2014
Active Locations (1)
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1
Cochin University Hospital
Paris, France, 75014