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Non-invasive Neurally Adjusted Ventilatory Assist

I

Insel Gruppe AG, University Hospital Bern

Status and phase

Withdrawn
Phase 1

Conditions

Respiratory Failure

Treatments

Device: non-invasive neurally adjusted ventilatory assist

Study type

Interventional

Funder types

Other

Identifiers

NCT01280383
BE KEK 123/10

Details and patient eligibility

About

Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assistance to spontaneous breathing based on the detection of the electrical activity of the diaphragm. The investigators will study the effects of non-invasive NAVA on respiratory muscle unloading critically ill patients.

Full description

To assess the effects of non-invasive NAVA on respiratory muscle unloading in critically ill patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 18 - 85 years
  • History of chronic obstructive lung disease
  • Invasive mechanical ventilation for more than 12 hours
  • Planned extubation according to the weaning protocol of our clinic
  • Informed consent obtained from a next of kin
  • Enrollment approval from a neutral physician neither participating in the study nor in the clinical treatment of the patient

Exclusion criteria

  • Tracheostomy
  • Facial or cranial trauma or surgery
  • Oral, esophageal, diaphragmatic or gastric trauma or surgery
  • Contraindication to insertion of a nasogastric tube (e. g. malformation, esophageal varices, esophageal perforation or rupture, Zenkers diverticulum, severe bleeding disorder)
  • Uncooperative state and combativeness not responding to low levels of sedatives
  • Neurological disease possibly influencing the brainstem respiratory centre, such as but not limited to: intracerebral, subarachnoidal or subdural hemorrhage, cerebral infarction, possible hypoxic encephalopathy
  • Next of kin refuses informed consent
  • Pregnancy. In female patients between 18 and 60 years of age, a pregnancy test will be performed.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

non-invasive NAVA
Experimental group
Description:
application of non-invasive NAVA in critically ill patients
Treatment:
Device: non-invasive neurally adjusted ventilatory assist

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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