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

NCT00614562 | Completed Phase 1

• 1 other identifier: KEK BE 250/07
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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)

Conditions

Polyneuropathy; Polymyopathy

Keywords

critical associated illness polyneuropathy or polymyopathy (CIP/M)

Outcome Measures

Primary Outcomes (1)

• Changes in mean inspiratory electrical activity of the diaphragm (Edi)

  beginning to end of study

Secondary Outcomes (1)

• Changes in ventilatory and respiratory parameters Changes in sedative and vasoactive drugs used

  beginning to end of study

Study Arms (1)

NAVA

EXPERIMENTAL

Device: Neurally adjusted ventilatory assist (NAVA)

Interventions

Neurally adjusted ventilatory assist (NAVA) DEVICE

NAVA for 72 hours

NAVA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• a white cell count of more than 12 000/mm3 or less than 4000/mm3 , or a differential count showing more than 10% immature neutrophils.
• B: MODS (s. Figure 15)
• C: treatment with corticosteroids for at least 24 hours (either as repeated bolus or as continuous infusion).
• D: treatment with neuro-muscular blocking agents for at least 24 hours (either as repeated bolus or as continuous infusion).

You may not qualify if:

• 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.
• 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 redefined tidal volume or airway pressure as per attending physician
• Severe hemodynamic instability as per attending physician

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Intensive Care Medicine, University Hospital - Inselspital

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: 10581089 BACKGROUND

• Tuchscherer D, Z'graggen WJ, Passath C, Takala J, Sinderby C, Brander L. Neurally adjusted ventilatory assist in patients with critical illness-associated polyneuromyopathy. Intensive Care Med. 2011 Dec;37(12):1951-61. doi: 10.1007/s00134-011-2376-0. Epub 2011 Nov 3.

  PMID: 22048718 DERIVED

MeSH Terms

Conditions

Polyneuropathies

Interventions

Interactive Ventilatory Support

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory 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: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2010
• Last Updated: February 3, 2011

Record last verified: 2011-02

Locations

CH (1)