Non-invasive Neurally Adjusted Ventilatory Assist | NCT01280383

Studies
Non-invasive Neurally Adjusted Ventilatory Assist

NCT01280383

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Withdrawn

Last Update Posted

Jul 23, 2015Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Respiratory Failure

Interventions

non-invasive neurally adjusted ventilatory assist

Countries

Not provided

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

Jul 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study does not meet the new legal requirements set forth in the Human Research Act

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Jan 10, 2011

First Submission Date that Met QC Criteria

Jan 19, 2011

First Posted Date

Jan 20, 2011Estimated

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

Jul 22, 2015

Last Update Posted Date

Jul 23, 2015Estimated

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

Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assistance to spontaneous breathing based on the detection of the electrical activity of the diaphragm. The investigators will study the effects of non-invasive NAVA on respiratory muscle unloading critically ill patients.

Detailed Description

To assess the effects of non-invasive NAVA on respiratory muscle unloading in critically ill patients

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non-invasive NAVA	Experimental	application of non-invasive NAVA in critically ill patients	Device: non-invasive neurally adjusted ventilatory assist

Interventions

Name	Type	Description	Arm Group Labels	Other Names
non-invasive neurally adjusted ventilatory assist	Device	non-invasive neurally adjusted ventilatory assist in critically ill patients	non-invasive NAVA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
patient-ventilator synchrony		outcomes are assessed at the end of each experimental period, i.e. every 20-30 minutes

Secondary Outcomes

Measure	Description	Time Frame
changes in respiratory pattern		study duration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 - 85 years
History of chronic obstructive lung disease
Invasive mechanical ventilation for more than 12 hours
Planned extubation according to the weaning protocol of our clinic
Informed consent obtained from a next of kin
Enrollment approval from a neutral physician neither participating in the study nor in the clinical treatment of the patient

Exclusion Criteria:

Tracheostomy
Facial or cranial trauma or surgery
Oral, esophageal, diaphragmatic or gastric trauma or surgery
Contraindication to insertion of a nasogastric tube (e. g. malformation, esophageal varices, esophageal perforation or rupture, Zenkers diverticulum, severe bleeding disorder)
Uncooperative state and combativeness not responding to low levels of sedatives
Neurological disease possibly influencing the brainstem respiratory centre, such as but not limited to: intracerebral, subarachnoidal or subdural hemorrhage, cerebral infarction, possible hypoxic encephalopathy
Next of kin refuses informed consent
Pregnancy. In female patients between 18 and 60 years of age, a pregnancy test will be performed.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Lukas Brander, MD	University Hospital (Inselspital) and University of Bern	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10581089	Background	Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindstrom L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. doi: 10.1038/71012. No abstract available.

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

ID	Term
D059725	Interactive Ventilatory Support
D063087	Noninvasive Ventilation

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