Mechanical Ventilation Controlled by the Electrical Activity of the Patient's Diaphragm - Effects of Changes in Ventilator Parameters on Breathing Pattern

NCT ID: NCT00529347

Last Updated: 2009-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-07-31

Brief Summary

Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assist to spontaneous breathing based on the detection of the electrical activity of the diaphragm. We study the effect of changing ventilatory parameters on the patient's breathing pattern during NAVA.

Conditions

Mechanical Ventilation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Interventions

neurally adjusted ventilatory assist (NAVA)

assessment of breathing pattern at various ventilator settings

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Invasive mechanical ventilation (tracheally intubated or tracheotomized)
• Presence of an arterial pressure line.
• Subject itself or its next of kin has given written informed consent

Exclusion Criteria

• Patient is less than 18 years or more than 85 years of age
• The attending physician refuses to allow enrollment
• The patient refuses informed consent
• Next of kin is unavailable or refuses informed consent
• Pregnant or breast-feeding female. A pregnancy test will be performed in all female patients less than 60 years of age.
• Any contraindication to insertion/exchange a nasogastric tube, including (but not limited to): severe oropharyngeal malformation or bleeding; esophageal varices, tumor, infection, stenosis, or rupture
• Presence or suspicion of diaphragm injury
• Hemophilia or other severe bleeding disorder
• Presence or suspicion of a central nervous system (CNS) disorder, including (but not limited to): CNS infarction, bleeding, tumor, or infection
• History of heart and/or lung transplantation
• Any mechanical cardiac assist device (excluding intraaortic balloon pump)
• Any contraindication to reduce sedation or to stop neuromuscular blockage in order to allow spontaneous breathing
• The patient needs to be ventilated with a mode of mechanical ventilation that targets a predefined tidal volume or airway pressure as per attending physician
• Severe hemodynamic instability as per attending physician
• Planned or anticipated intervention within the study period necessitating either transfer out of the ICU or requiring prolonged interaction with the patient.
• A fraction of inspired oxygen (FiO2) of > 0.8
• The patient currently participates in another interventional clinical trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

University Hospital Inselspital, Berne

Principal Investigators

Lukas Brander, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Intensive Care Medicine, University Hospital, Bern, Switzerland

Locations

Department of Intensive Care Medicine, University Hospital - Inselspital

Bern, Canton of Bern, Switzerland

Countries

Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 10581089 (View on PubMed)

Passath C, Takala J, Tuchscherer D, Jakob SM, Sinderby C, Brander L. Physiologic response to changing positive end-expiratory pressure during neurally adjusted ventilatory assist in sedated, critically ill adults. Chest. 2010 Sep;138(3):578-87. doi: 10.1378/chest.10-0286. Epub 2010 Apr 30.

Reference Type: DERIVED

PMID: 20435654 (View on PubMed)

Other Identifiers

SNF-3200B0-113478-1

Identifier Type: -

Identifier Source: org_study_id