Non-invasive Neurally Adjusted Ventilatory Assist

NCT01280383 | Withdrawn Phase 1

• 1 other identifier: BE KEK 123/10
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Failure

Keywords

non-invasive ventilation; diaphragm; electrical activity; neurally adjusted ventilatory assist; critically ill patients

Outcome Measures

Primary Outcomes (1)

• patient-ventilator synchrony

  outcomes are assessed at the end of each experimental period, i.e. every 20-30 minutes

Secondary Outcomes (1)

• changes in respiratory pattern

  study duration

Study Arms (1)

non-invasive NAVA

EXPERIMENTAL

application of non-invasive NAVA in critically ill patients

Device: non-invasive neurally adjusted ventilatory assist

Interventions

non-invasive neurally adjusted ventilatory assist DEVICE

non-invasive neurally adjusted ventilatory assist in critically ill patients

Also known as: neurally adjusted ventilatory assist, non-invasive ventilation

non-invasive NAVA

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Related Publications (1)

• 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.

  PMID: 10581089 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Interactive Ventilatory Support; Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Lukas Brander, MD

  University Hospital (Inselspital) and University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: January 20, 2011
• Study Start: November 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 23, 2015

Record last verified: 2015-07