Neurally Adjusted Ventilatory Assist (NAVA) in Patients With Critical Illness Associated Polyneuropathy / or Polymyopathy (CIP/M)

Insel Gruppe AG, University Hospital Bern1 site in 1 country15 target enrollmentJanuary 2008

ConditionsPolyneuropathy Polymyopathy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Polyneuropathy
Sponsor: Insel Gruppe AG, University Hospital Bern
Enrollment: 15
Locations: 1
Primary Endpoint: Changes in mean inspiratory electrical activity of the diaphragm (Edi)
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 NAVA in patients with critical illness associated polyneuropathy / polymyopathy (CIP/M)

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

December 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Insel Gruppe AG, University Hospital Bern

Eligibility Criteria

Inclusion Criteria

•Subject itself or its next of kin has given written informed consent
•Independent physician has given written informed consent
•Male or female patients aged 18 - 80 years (extremes included).
•Mechanical ventilation for ≥ 48 hours prior to enrolment
•Presence of Critical Illness Polyneuropathy / Polymyopathy (CIP/M) according to the MRC Scale for Muscle Examination in 12 Muscle groups (Table 1) with or without loss of sensibility and muscle reflexes.
•Presence of at least one of the following risk factors (A - D) known to be associated with CIP/M. Note, the risk factor does not need to be present at enrolment but needs to have been present prior to enrolment during the actual stay in the ICU:
•A: severe sepsis defined as the presence of an infection is highly suspected or proven and three or more of the following systemic inflammatory response syndrome (SIRS) criteria are met (Bernard et al 2001 s. Figure 15):
•core temperature greater than 38 degrees celsius (100.4 degrees F) or less than 36 degrees celsius (96.8 degrees F);
•heart rate greater than 90 beats per minute;
•respiratory rate greater than 20 breaths per minute, or arterial carbon dioxide tension (Paco2) greater than 32 mm Hg, or mechanical ventilation for an acute process;

Exclusion Criteria

•Patient is less than 18 years or more than 80 years of age
•The attending physician refuses to allow enrollment
•The patient refuses informed consent
•Next of kin is unavailable or refuses informed consent
•The independent physician 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, bleeding disorder with evidence of active bleeding.
•Presence or suspicion of diaphragm injury
•Presence or suspicion of a central nervous system (CNS) proximal of the spinal cord level C2) including (but not limited to): infarction, bleeding, tumor, or infection in the CNS
•Presence or suspicion of any preexisting peripheral neuromuscular disorder.