NCT00529347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

September 9, 2009

Status Verified

September 1, 2009

Enrollment Period

1.3 years

First QC Date

September 12, 2007

Last Update Submit

September 7, 2009

Conditions

Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

  • Change in diaphragmatic Edi (area under the curve) during expiration

    At each intervention

Interventions

neurally adjusted ventilatory assist (NAVA)DEVICE

assessment of breathing pattern at various ventilator settings

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Intensive Care Medicine, University Hospital - Inselspital

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (2)

  • 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: 10581089BACKGROUND

  • 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.

    PMID: 20435654DERIVED

MeSH Terms

Interventions

Interactive Ventilatory Support

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Lukas Brander, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2007

First Posted

September 14, 2007

Study Start

September 1, 2007

Primary Completion

January 1, 2009

Study Completion

July 1, 2009

Last Updated

September 9, 2009

Record last verified: 2009-09

Locations

CH(1)