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

Not Applicable

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Device: Oxymizer® compared to CNC

• Registration Number: NCT02268981
• Lead Sponsor: Schön Klinik Berchtesgadener Land

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-10-16
• Study First Posted: 2014-10-20
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-02
• Last Update Posted: 2015-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxymizer® compared to CNC	Oxymizer® compared to CNC	From 7am to 7pm oxygen saturation is measured by a pulse oximeter. One day with conventional nasal cannula, one day with Oxymizer®, one day with Oxymizer® and reduced Oxygen flow (-1l/min). The order of these days is randomized in 6 groups. The intervention will be performed on consecutive days and twice during study period.

Primary Outcome Measures

Name	Time	Method
Difference in oxygen saturation between Oxymizer and conventional nasal cannula	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.

Trial Locations

Locations (1)

Klinikum Berchtesgadener Land der Schön-Kliniken; 🇩🇪 Schoenau am Koenigssee, Bayern, Germany