Physiological and Clinical Changes in NHF Therapy | NCT02504814

Studies
Physiological and Clinical Changes in NHF Therapy

NCT02504814

Sponsor

University of Leipzig

Status

Completed

Last Update Posted

Feb 18, 2019Actual

Enrollment

64Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease
Hypercapnia
Interstitital Lung Disease

Interventions

Nasal Highflow (NHF)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011Actual

Primary Completion Date

Jun 2018Actual

Completion Date

Jun 2018Actual

First Submitted Date

May 27, 2015

First Submission Date that Met QC Criteria

Jul 20, 2015

First Posted Date

Jul 22, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2019

Last Update Posted Date

Feb 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ventilatory effects	Experimental	measuring mean airway pressure, breathing volumes and decrease in hypercapnia	Device: Nasal Highflow (NHF)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nasal Highflow (NHF)	Device	changes in breathing physiology in NHF	ventilatory effects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
changes in partial pressure of carbon dioxide (CO2) in arterial blood (pCO2)		4 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COPD, ILD

Exclusion Criteria:

Unstable disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens Bräunlich, MD	University of Leipzig	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jens Bräunlich		Leipzig	Saxony	04103	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29368599	Derived	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.

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D006935	Hypercapnia

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease