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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00529347
Other study ID # SNF-3200B0-113478-1
Secondary ID
Status Completed
Phase Phase 1
First received September 12, 2007
Last updated September 7, 2009
Start date September 2007
Est. completion date July 2009

Study information

Verified date September 2009
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date July 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Device:
neurally adjusted ventilatory assist (NAVA)
assessment of breathing pattern at various ventilator settings

Locations

Country Name City State
Switzerland Department of Intensive Care Medicine, University Hospital - Inselspital Bern

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindström L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in diaphragmatic Edi (area under the curve) during expiration At each intervention No
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