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

S

Schön Klinik Berchtesgadener Land

Status

Completed

Conditions

Idiopathic Pulmonary Fibrosis

Treatments

Device: Oxymizer® compared to CNC

Study type

Interventional

Funder types

Other

Identifiers

NCT02268981
12hOXY-ILD2014

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

Oxymizer® compared to CNC
Experimental group
Description:
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.
Treatment:
Device: Oxymizer® compared to CNC
Device: Oxymizer® compared to CNC
Device: Oxymizer® compared to CNC

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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