Evaluation of Automatic Oxygen Flow Titration During Walking in Patients With COPD

COPD Clinical Trial

— FreeO2rehab  

Official title:

Evaluation of Automatic Oxygen Flow Titration During Walking in Patients With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150434
• Other study ID #: FreeO2-Rehab-1
• Status: Completed
• Phase: N/A
• First received: May 26, 2014
• Last updated: May 28, 2014
• Start date: November 2009
• Est. completion date: June 2013

Study information

• Verified date: May 2014
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of the current study was to evaluate a new system (FreeO2) that automatically titrates oxygen flow to maintain stable SpO2, in patients with moderate or severe chronic obstructive pulmonary disease during exercise. The investigators hypothesized that continuous automatic adjustment of the oxygen flows during exercise would better maintain patients within the oxygenation target, reduce episodes of desaturation and hyperoxia and would improve walking exercise tolerance in comparison with fixed levels of low-flow oxygen and with compressed air breathing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 40 years

• Moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease guidelines

• Who did not require long-term oxygen therapy were included in the study.

• Patients were also selected on the basis of known (end-exercise SpO2 < 90% on a previous exercise test) or suspected (SpO2 < 95% at rest) desaturation during exercise

Exclusion Criteria:

• Episode of exacerbation or hospitalisation within last four weeks

• Current medical condition that could influence exercise tolerance

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Endurance Shuttle Walking Test (Exercise at 85% of Maximal Shuttle Walking Test)
• Exercise

Intervention

Device:
• Automated oxygen titration
Automated oxygen titration every second to maintain stable SpO2 at a predefined value (94% in the present study)

Drug:
• Compressed air
compressed air delivered at a fixed flow of 2 L/min
• Oxygen constant flow
oxygen delivered at a fixed flow of 2L/min

Locations

Country	Name	City	State
Canada	Centre de recherche de l'IUCPQ	Québec	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Laval University	Canada Foundation for Innovation, Fonds de la Recherche en Santé du Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physiological parameters	Physiological parameters continuously recorded by the FreeO2 system (SpO2, end-tidal CO2 [EtCO2], respiratory rate, heart rate and oxygen flow when automated oxygen titration was activated), blood gases (before and after ESWT and after recovery) and dyspnea assessment during ESWT with a 10-point Borg scale	during ESWT	No
Primary	Time within predefined SpO2 target	The primary outcome of the study was the percentage of exercise time during which patients were kept within the SpO2 target of 92 to 96%	during exercise (Endurance shuttle walking test)	Yes
Secondary	Exercise tolerance	Endurance shuttle walking test time and distance	duration of ESWT	No