NOWOX Oxygen Therapy Monitoring Device

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: NOWOX

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

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Cochin University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: oxygen therapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary performance criterion is the overall estimated duration of oxygen use	6 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
secondary performance criterion: instantaneous respiration rate recorded by the NOWOX	6 hours
secondary performance criterion: patient's satisfaction questionnaire on the NOWOX	1 hour

Collaborators and Investigators

• Sponsor: Air Liquide SA
• Investigators: Principal Investigator: Anh-Tuan DINH-XUAN, Professor-MD, Department of Physiology - Cochin University Hospital - FRANCE

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (ACTUAL): February 1, 2010
• Study Completion (ACTUAL): February 1, 2010

Study Registration Dates

• First Submitted: November 28, 2008
• First Submitted That Met QC Criteria: November 28, 2008
• First Posted (ESTIMATE): December 1, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): February 27, 2014
• Last Update Submitted That Met QC Criteria: February 26, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: to verify accurrancy of data collected by the NOWOX
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ALMED-07-MD-015