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

Polyneuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614562
• Other study ID #: KEK BE 250/07
• Status: Completed
• Phase: Phase 1
• First received: January 31, 2008
• Last updated: February 2, 2011
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: February 2011
• 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 NAVA in patients with critical illness associated polyneuropathy / polymyopathy (CIP/M)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Subject itself or its next of kin has given written informed consent

2. Independent physician has given written informed consent

3. Male or female patients aged 18 - 80 years (extremes included).

4. Mechanical ventilation for = 48 hours prior to enrolment

5. 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.

6. 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).

Exclusion Criteria:

1. Patient is less than 18 years or more than 80 years of age

2. The attending physician refuses to allow enrollment

3. The patient refuses informed consent

4. Next of kin is unavailable or refuses informed consent

5. The independent physician refuses informed consent

6. Pregnant or breast-feeding female. A pregnancy test will be performed in all female patients less than 60 years of age

7. 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.

8. Presence or suspicion of diaphragm injury

9. 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

10. Presence or suspicion of any preexisting peripheral neuromuscular disorder.

11. History of heart and/or lung transplantation

12. Any mechanical cardiac assist device (excluding intraaortic balloon pump)

13. Any contraindication to reduce sedation or to stop neuromuscular blockage in order to allow spontaneous breathing

14. 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

15. Severe hemodynamic instability as per attending physician

16. A fraction of inspired oxygen (FiO2) of > 0.8 at enrollment.

17. The patient currently participates in another interventional clinical trial

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Polymyopathy
• Polyneuropathies
• Polyneuropathy

Intervention

Device:
• Neurally adjusted ventilatory assist (NAVA)
NAVA for 72 hours

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	Changes in mean inspiratory electrical activity of the diaphragm (Edi)		beginning to end of study	No
Secondary	Changes in ventilatory and respiratory parameters Changes in sedative and vasoactive drugs used		beginning to end of study	No