NOWOX Oxygen Therapy Monitoring Device - Full Text View

Sponsored by:	Air Liquide SA
Information provided by:	Air Liquide SA
ClinicalTrials.gov Identifier:	NCT00800072

Purpose

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.

Condition	Intervention
Chronic Obstructive Pulmonary Disease	Device: NOWOX

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Uncontrolled, Single Group Assignment
Official Title:	Evaluation of NOWOX: a Medical Device Developed to Record Duration of Oxygen Use and Respiration Rate in Patients Requiring Oxygen Therapy

Further study details as provided by Air Liquide SA:

Primary Outcome Measures:

Primary performance criterion is the overall estimated duration of oxygen use [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

secondary performance criterion: instantaneous respiration rate recorded by the NOWOX [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
secondary performance criterion: patient's satisfaction questionnaire on the NOWOX [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Estimated Enrollment:	1
Study Start Date:	November 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
oxygen therapy: Experimental one experimental device assigned to each of the 10 patients including in the study for an experiemental session duration of 6 hours	Device: NOWOX one experimental device assigned to each of the 10 patients including in the study for an experiemental session duration of 6 hours

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800072

Contacts

Contact: Anh-Tuan DINH-XUAN, Professor-MD

+ 33 1 58 41 22 91

anh-tuan.dinh-xuan@cch.aphp.fr

Locations

France
Cochin University Hospital	Recruiting
PARIS, France, 75014
Principal Investigator: Anh-Tuan DINH-XUAN, MD Professor

Sponsors and Collaborators

Air Liquide SA

Investigators

Principal Investigator:

Anh-Tuan DINH-XUAN, Professor-MD

Department of Physiology - Cochin University Hospital - FRANCE

More Information

Responsible Party:	AIR LIQUIDE SA ( Mr Philippe ROUAULT/Director CRCD )
Study ID Numbers:	ALMED-07-MD-015
Study First Received:	November 28, 2008
Last Updated:	November 28, 2008
ClinicalTrials.gov Identifier:	NCT00800072
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Air Liquide SA:

to verify accurrancy of data collected by the NOWOX

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on January 16, 2009