NCT02504814

Brief Summary

The study explores the changes in pressure, volume and in hypercapnia in patients with COPD and ILD. The investigators will use different application forms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

7 years

First QC Date

May 27, 2015

Last Update Submit

February 14, 2019

Conditions

Chronic Obstructive Pulmonary DiseaseHypercapniaInterstitital Lung Disease

Keywords

nasal high flow

Outcome Measures

Primary Outcomes (3)

  • changes in mean airway pressure (mbar)

    1 month

  • changes in tidal and minute volume (l)

    1 month

  • changes in breathing frequency (beats/ minute)

    1 month

Secondary Outcomes (1)

  • changes in partial pressure of carbon dioxide (CO2) in arterial blood (pCO2)

    4 month

Study Arms (1)

ventilatory effects

EXPERIMENTAL

measuring mean airway pressure, breathing volumes and decrease in hypercapnia

Device: Nasal Highflow (NHF)

Interventions

Nasal Highflow (NHF)DEVICE

changes in breathing physiology in NHF

Also known as: TNI softflow50
ventilatory effects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD, ILD

You may not qualify if:

  • Unstable disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jens Bräunlich

Leipzig, Saxony, 04103, Germany

Location

Related Publications (1)

  • Braunlich J, Mauersberger F, Wirtz H. Effectiveness of nasal highflow in hypercapnic COPD patients is flow and leakage dependent. BMC Pulm Med. 2018 Jan 24;18(1):14. doi: 10.1186/s12890-018-0576-x.

    PMID: 29368599DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHypercapnia

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Jens Bräunlich, MD

    University of Leipzig

    STUDY DIRECTOR

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
MD

Study Record Dates

First Submitted

May 27, 2015

First Posted

July 22, 2015

Study Start

June 1, 2011

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

February 18, 2019

Record last verified: 2019-02

Locations

DE(1)