Clinical trial NCT00800072: NOWOX Oxygen Therapy Monitoring Device
Official title: Evaluation of NOWOX: a Medical Device Developed to Record Duration of Oxygen Use and Respiration Rate in Patients Requiring Oxygen Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: to verify accurrancy of data collected by the NOWOX
Lead sponsor: Air Liquide SA
Sponsor class: INDUSTRY
First posted: 2008-12-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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 oxygen therapy.

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 at home in patients who have chronic cardio respiratory failure and severe resting hypoxemia to maintain sufficient blood oxygenation and therefore preserve vital organ function.

LTOT effectiveness has mainly been evaluated and documented in patients with COPD, which also accounts for most of its prescriptions. In these patients, LTOT has been shown to have a beneficial impact on haemodynamics, exercise capacity, lung mechanics and mental state. Its implementation was furthermore associated with reduced yearly hospitalisation days and increased survival Measuring adherence is an extremely important and under-evaluated component of oxygen therapy. NOWOX, medical device has been designed,developed and manufactured to measure adherence to LTOT and additionally to measure patient's respiration rate

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Primary performance criterion is the overall estimated duration of oxygen use
timeFrame: 6 hours
Secondary outcomes:
measure: secondary performance criterion: instantaneous respiration rate recorded by the NOWOX
timeFrame: 6 hours
measure: secondary performance criterion: patient's satisfaction questionnaire on the NOWOX
timeFrame: 1 hour
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin University Hospital
Study officials:
affiliation: Department of Physiology - Cochin University Hospital - FRANCE
name: Anh-Tuan DINH-XUAN, Professor-MD
role: PRINCIPAL_INVESTIGATOR
References: