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

NCT ID: NCT02268981

Last Updated: 2015-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Oxymizer® compared to CNC

Intervention Type DEVICE

Oxygen Saturation measurement for 12 h with CNC

Oxymizer® compared to CNC

Intervention Type DEVICE

Oxygen Saturation measurement for 12 h with Oxymizer®

Oxymizer® compared to CNC

Intervention Type DEVICE

Saturation measurement for 12 h with Oxymizer® by reduced flow rate (-1l/min)

Interventions

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Oxymizer® compared to CNC

Oxygen Saturation measurement for 12 h with CNC

Intervention Type DEVICE

Oxymizer® compared to CNC

Oxygen Saturation measurement for 12 h with Oxymizer®

Intervention Type DEVICE

Oxymizer® compared to CNC

Saturation measurement for 12 h with Oxymizer® by reduced flow rate (-1l/min)

Intervention Type DEVICE

Other Intervention Names

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Conventional Nasal Cannula (CNC) Oxymizer Oxymizer with reduced flow rate (-1l/min)

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schön Klinik Berchtesgadener Land

OTHER

Sponsor Role lead

Responsible Party

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Klaus Kenn

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Klaus Kenn, Dr. med

Role: STUDY_CHAIR

Schoen Klinik BGL

Locations

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Klinikum Berchtesgadener Land der Schön-Kliniken

Schönau am Königssee, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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12hOXY-ILD2014

Identifier Type: -

Identifier Source: org_study_id

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