Non-invasive Neurally Adjusted Ventilatory Assist

Non-invasive Neurally Adjusted Ventilatory Assist (niNAVA) After Extubation: Proposal for a Crossover-randomized Feasibility Trial

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01280383

Enrollment

Registered

2011-01-20

Start date

2010-11-30

Completion date

2015-05-31

Last updated

2015-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

Keywords

non-invasive ventilation, diaphragm, electrical activity, neurally adjusted ventilatory assist, critically ill patients

Brief summary

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.

Detailed description

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

Interventions

DEVICEnon-invasive neurally adjusted ventilatory assist

non-invasive neurally adjusted ventilatory assist in critically ill patients

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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.

Design outcomes

Primary

Measure	Time frame
patient-ventilator synchrony	outcomes are assessed at the end of each experimental period, i.e. every 20-30 minutes

Secondary

Measure	Time frame
changes in respiratory pattern	study duration

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026