A Study of Expiratory Pressure Modulation in Moderate to... | NCT02585752

Studies
A Study of Expiratory Pressure Modulation in Moderate to Severe COPD Patients - Phase 1b

NCT02585752

Sponsor

ResMed

Status

Terminated

Last Update Posted

Apr 23, 2018Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Noninvasive ventilation

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

Apr 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low recruitment

Expanded Access Info

Start Date

Oct 1, 2015Actual

Primary Completion Date

Sep 30, 2017Actual

Completion Date

Nov 24, 2017Actual

First Submitted Date

Oct 20, 2015

First Submission Date that Met QC Criteria

Oct 22, 2015

First Posted Date

Oct 23, 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

Apr 19, 2018

Last Update Posted Date

Apr 23, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

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

Dynamic pulmonary hyperinflation (DH) and intrinsic positive end-expiratory pressure (PEEP) are well known problems in COPD patients with acute and chronic respiratory failure. Measurement of intrinsic PEEP level during both, invasive and non-invasive ventilation is of major importance since in some circumstances (e.g. during exercise or during exacerbations) it can significantly increase respiratory workload of COPD patients. Extrinsic PEEP applied during both, invasive and noninvasive ventilation is used to overcome intrinsic PEEP and therefore to avoid or reduce dynamic hyperinflation.

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single centre, single arm	Experimental	Noninvasive ventilation with expiratory modulation. Assessment of comfort and blood gases.	Device: Noninvasive ventilation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Noninvasive ventilation	Device	Expiratory pressure modulation	Single centre, single arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Analogue Scale	Subjective rating of comfort during expiration	1 day

Secondary Outcomes

Measure	Description	Time Frame
Minute ventilation	Volume of inhaled air in one minute (L/min)	1 day
Respiratory rate	Number of breaths per minute (breaths/min)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years who are contractually capable and mentally able to understand and follow the instructions of the study personnel
Signed informed consent
Moderate to severe COPD patients (FEV1/FVC ratio <70% and FEV1 < 50% pred) with chronic hypercapnic respiratory failure (PaCO2 >45 mmHg)
Currently using NIV

Exclusion Criteria:

Acute exacerbation of COPD, acute respiratory failure (ph < 7,35 and/or respiratory rate >30/min)
Unstable heart failure
Cardiac failure with dehydration
Pregnancy/breastfeeding women
Pneumothorax/-mediastinum
Increased risk of pneumothorax, pneumomediastinum or venous air embolism
In the opinion of the investigator, the patient is unsuitable for the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 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
Michael Dreher, MD	Universitätsklinikum Aachen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum Aachen		Aachen	North Rhine-Westphalia	52074	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	Cornelissen CG, Müller T, Schmitz S, Dreher M. Nichtinvasive Beatmung: Patientenkomfort und Sicherheit einer Modulation des expiratorischen Flusses. Pneumologie 2018; 72(S01), S11

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

ID	Term
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics
D012138	Respiratory Therapy