The Effects of Airtrapping on Sleep and Breathing in Non... | NCT01987661

Studies
The Effects of Airtrapping on Sleep and Breathing in Non Invasive Ventilation (NIV) in COPD

NCT01987661

Sponsor

Institut für Pneumologie Hagen Ambrock eV

Status

Completed

Last Update Posted

Feb 11, 2019Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

COPD
Hypercapnic Respiratory Failure

Interventions

BIPAP ST
Airtrap

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

Oct 2013

Primary Completion Date

Mar 1, 2018Actual

Completion Date

Mar 1, 2018Actual

First Submitted Date

Nov 13, 2013

First Submission Date that Met QC Criteria

Nov 13, 2013

First Posted Date

Nov 19, 2013Estimated

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 8, 2019

Last Update Posted Date

Feb 11, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Georg Nilius, Head of Helios Klinik Hagen Ambrock, Klinik für Pneumologie, Institut für Pneumologie Hagen Ambrock eVPrincipal Investigator

Lead Sponsor

Institut für Pneumologie Hagen Ambrock eVINDUSTRY

Collaborators

Name	Class
Weinmann Geräte für Medizin GmbH + Co. KG	INDUSTRY

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

15 COPD patients will be surveyed in this prospective randomized crossover pilot study concerning non invasive ventilation. Patients will be treated over 2 nights in randomized order with Ventimotion2 (Weinmann) with and without Airtrap Control under Polysomnography (PSG) surveillance including transcutaneous pCO2 measurement. The sleep quality is judged by evaluating the PSG and pCO2 values over night.

Target parameters are respiratory rate, sleep quality and influence of Airtrap Control on pCO2 values over night.

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

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bilevel ventilation BIPAP ST	Active Comparator	one night, BIPAP ST ventilation with individually optimised pressure parameters and supplemental oxygen if necessary.	Device: BIPAP ST
BIPAP ST plus Airtrap	Experimental	one night, BIPAP ST ventilation with "Airtrap control", same pressure parameters and oxygen.	Device: BIPAP ST Device: Airtrap

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BIPAP ST	Device	non invasive ventilation, individually titrated for each patient, if necessary combined with oxygen, to improve hypercapnic respiratory failure.	BIPAP ST plus Airtrap

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
breathing frequency	breathing frequency measured with the flow signal of a polysomnography during non invasive ventilation over night	2 nights

Secondary Outcomes

Measure	Description	Time Frame
mean pCO2 level	mean pCO2 level over night measured with a transcutanous pCO2 monitor (TOSCA)	2 nights

Other Outcomes

Measure	Description	Time Frame
Sleep efficiency	Sleep efficiency is defined by the relation of "time in bed" to "total sleep time" in the overnight polysomnography protocol	2 nights

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stable respiratory situation
Clinically required NIV
Capable of giving consent

Exclusion Criteria:

Invasive ventilation
Any other severe physical disease that requires immediate medical assistance
Acute hypercapnic decompensation with pH <7.30 in routine BGA
Circumstances that doesn't allow mask ventilation (e.g. facial deformation)
Participation in a clinical trial within the last 4 weeks
Pregnancy or nursing period
Drug addiction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Georg Nilius, MD	Helios Klinik Hagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helios Klinik Hagen		Hagen	North Rhine-Westphalia	58091	Germany

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D012131	Respiratory Insufficiency

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided