NCT03411876

Brief Summary

Aim of this study is to investigate the effects of an Oxymizer pendant nasal cannula in hypoxemic patients with idiopathic pulmonary fibrosis during walking.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

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

First Submitted

Initial submission to the registry

January 18, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

January 18, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

12 months

First QC Date

January 18, 2018

Last Update Submit

April 15, 2020

Conditions

Idiopathic Pulmonary FibrosisHypoxemia

Keywords

IPFOxymizeroxygen conserving devicepulmonary disease

Outcome Measures

Primary Outcomes (1)

  • Endurance shuttle walk test distance

    Distance patients walk during an endurance shuttle walk test

    at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test

Secondary Outcomes (5)

  • oxygen saturation

    at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test

  • heart rate

    at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test

  • breathing frequency

    at baseline, at isotime of endurance shuttle walk test and at the end (maximal 20 min) of endurance shuttle walk test

  • carbon dioxide pressure

    at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test

  • time to desaturation

    From beginning of endurance shuttle walk test until the oxygen saturation reaches defined thresholds, or ESWT reaches maximum time frame of 20 minutes

Study Arms (2)

First ESWT with Oxymizer, second ESWT with CNC

EXPERIMENTAL

Patients in this study arm first perform the first endurance shuttle walk test (ESWT) with the Oxymizer and the second ESWT with a conventional nasal cannula (CNC).

Device: Oxymizer® pendant nasal cannulaDevice: conventional nasal cannula

First ESWT with CNC, second ESWT with Oxymizer

EXPERIMENTAL

Patients in this study arm first perform the first endurance shuttle walk test (ESWT) with the CNC and the second ESWT with the Oxymizer.

Device: Oxymizer® pendant nasal cannulaDevice: conventional nasal cannula

Interventions

Oxymizer® pendant nasal cannulaDEVICE

Supplemental oxygen is provided by an Oxymizer pendant nasal cannula.

First ESWT with CNC, second ESWT with OxymizerFirst ESWT with Oxymizer, second ESWT with CNC
conventional nasal cannulaDEVICE

Supplemental oxygen is provided by a conventional nasal cannula.

First ESWT with CNC, second ESWT with OxymizerFirst ESWT with Oxymizer, second ESWT with CNC

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • firmed diagnosis of idiopathic pulmonary fibrosis
  • indication for supplemental oxygen therapy during exercise
  • referred to an inpatient rehabilitation program at the Schön Klinik Berchtesgadener Land

You may not qualify if:

  • cardiovascular diseases that influence the patient's physical performance
  • orthopedic comorbidities that prevent the patient from performing an incremental or endurance shuttle walk test
  • carbon dioxide pressure above 45 mmHg at rest and ambient air

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schön Klinik Berchtesgadener Land

Schönau am Königssee, Germany

Location

MeSH Terms

Conditions

Idiopathic Pulmonary FibrosisHypoxiaLung Diseases

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

January 18, 2018

First Posted

January 26, 2018

Study Start

January 18, 2018

Primary Completion

January 15, 2019

Study Completion

January 15, 2019

Last Updated

April 16, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)