Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)

This study will investigate the effects of a reservoir nasal cannula (Oxymizer®) compared to a conventional nasal cannula (CNC) in patients with idiopathic pulmonary fibrosis.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Berchtesgadener Land der Schön-Kliniken

Schönau am Königssee, Bavaria, 83471, Germany

About this study

Patients will be recruited during a 3-week inpatient pulmonary rehabilitation program. They will perform the following three interventions on consecutive days and will repeat them after a week. During these days the time table for prescribed physical activities and therapies will be kept in a comparable fashion.

The following 3 interventions will be performed in randomized order:

Day A: The Patient wears a conventional nasal cannula for 12 h with oxygen flow rate as prescribed during ADL

Day B: The Patient wears the Oxymizer® with prescribed oxygen flow rate for 12 h during ADL

Day C: The patient wears the Oxymizer® with a flow rate reduced by 1l/min in comparison to the prescribed oxygen flow rate, for 12h

The following week the same measurements will be repeated. The mean of the corresponding two measures will be calculated for each approach.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

IPF patients with indication for long term oxygen therapy ≥ 2l/min
VC >30% and < 70% pred.

Exclusion criteria

failure to comply with study process
acute infection

Treatment and study plan

Oxymizer® compared to CNC

Device

Oxygen Saturation measurement for 12 h with CNC

Other names: Conventional Nasal Cannula (CNC)

Primary outcomes

Difference in oxygen saturation between Oxymizer and conventional nasal cannula

Time frame: day 1 to 13

Oxygen Saturation will be measured via pulseoxymetry for 12 hours. On 2 days, mean oxygen Saturation will be reported while using Oxymizer or a conventional nasal cannula, both with similar Oxygen flow. The difference of the mean Oxygen Saturation of 12 hours between both cannulae will be the Primary outcome.

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Oct 20, 2014
Registry last updated: Sep 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed