NCT02268981

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 3, 2015

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

September 17, 2014

Last Update Submit

September 2, 2015

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

OxymizerOxygen conserving deviceConventional nasal cannula (CNC)Idiopathic pulmonary fibrosis

Outcome Measures

Primary Outcomes (1)

  • Difference in oxygen saturation between Oxymizer and conventional nasal cannula

    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.

    day 1 to 13

Study Arms (1)

Oxymizer® compared to CNC

EXPERIMENTAL

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.

Device: Oxymizer® compared to CNC

Interventions

Oxymizer® compared to CNCDEVICE

Oxygen Saturation measurement for 12 h with CNC

Also known as: Conventional Nasal Cannula (CNC)
Oxymizer® compared to CNC

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • failure to comply with study process
  • acute infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Berchtesgadener Land der Schön-Kliniken

Schönau am Königssee, Bavaria, 83471, Germany

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Officials

  • Klaus Kenn, Dr. med

    Schoen Klinik BGL

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

September 17, 2014

First Posted

October 20, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 3, 2015

Record last verified: 2015-09

Locations

DE(1)