Efficacy of Two Liquid Oxygen Devices in Deambulation

To Determine the Efficacy of Two Liquid Oxygen Device Clinical Trial

Official title:

Efficacy of Two Liquid Oxygen Devices in Deambulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086891
• Other study ID #: 07/060/793
• Status: Completed
• Phase: N/A
• First received: February 3, 2010
• Last updated: August 29, 2013
• Start date: April 2008
• Est. completion date: February 2010

Study information

• Verified date: May 2012
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española del Medicamento y productos Sanitarios (AEMPS)
• Study type: Interventional

Clinical Trial Summary

Some oxygen conserving devices have been developed to diminish oxygen expense. These devices offer optimisation of oxygen therapy for deambulation by improving time autonomy of patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with arterial oxygen desaturation to effort.

• COPD with TLC > 90%

• EPID with TLC < 90% and FEV1/FVC > 70%

Exclusion Criteria:

• Patients with long-term oxygen therapy (LTOT) in deambulation.

• Not clinically stable during last month.

• Smokers

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• To Determine the Efficacy of Two Liquid Oxygen Device

Intervention

Device:
• Oxygen conserving devices
Three 6MWT test will be performed at random with conventional oxygen continuous-flow,by Oxymizer Pendant and demand valve system. The percentage of patients correcting their desaturation and patients' acceptance of every method will be determinated.
• Oxygen conserving devices
Three 6MWT test will be performed at random with conventional oxygen continuous-flow,by Oxymizer Pendant and demand valve system. The percentage of patients correcting their desaturation and patients' acceptance of every method will be determinated

Locations

Country	Name	City	State
Spain	Fundacio Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the efficacy of correcting desaturation during effort and the acceptance of two different oxygen conserving devices during deambulation,one system with reservoir an another one with oxygen demand valve.		2 years	Yes