NOWOX Oxygen Therapy Monitoring Device

NCT00800072 | Completed

• 1 other identifier: ALMED-07-MD-015
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

to verify accurrancy of data collected by the NOWOX

Outcome Measures

Primary Outcomes (1)

• Primary performance criterion is the overall estimated duration of oxygen use

  6 hours

Secondary Outcomes (2)

• secondary performance criterion: instantaneous respiration rate recorded by the NOWOX

  6 hours

• secondary performance criterion: patient's satisfaction questionnaire on the NOWOX

  1 hour

Study Arms (1)

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

Interventions

NOWOX DEVICE

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

oxygen therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Air Liquide SA: lead

Study Sites (1)

Cochin University Hospital

Paris, 75014, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anh-Tuan DINH-XUAN, Professor-MD

  Department of Physiology - Cochin University Hospital - FRANCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2008
• First Posted: December 1, 2008
• Study Start: November 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: February 27, 2014

Record last verified: 2014-02

Locations

FR (1)