NOWOX Oxygen Therapy Monitoring Device

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Evaluation of NOWOX: a Medical Device Developed to Record Duration of Oxygen Use and Respiration Rate in Patients Requiring Oxygen Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800072
• Other study ID #: ALMED-07-MD-015
• Status: Completed
• Phase: N/A
• First received: November 28, 2008
• Last updated: February 26, 2014
• Start date: November 2008
• Est. completion date: February 2010

Study information

• Verified date: February 2014
• Source: Air Liquide SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• NOWOX
one experimental device assigned to each of the 10 patients including in the study for an experiemental session duration of 6 hours

Locations

Country	Name	City	State
France	Cochin University Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Air Liquide SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary performance criterion is the overall estimated duration of oxygen use		6 hours	No
Secondary	secondary performance criterion: instantaneous respiration rate recorded by the NOWOX		6 hours	No
Secondary	secondary performance criterion: patient's satisfaction questionnaire on the NOWOX		1 hour	No