Non-invasive Neurally Adjusted Ventilatory Assist

Study Overview
=================
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

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

Conditions
-----------------
Respiratory Failure

Intervention / Treatment
-----------------
* Device: non-invasive neurally adjusted ventilatory assist


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-invasive NAVA<br>application of non-invasive NAVA in critically ill patients | Device: non-invasive neurally adjusted ventilatory assist<br>* non-invasive neurally adjusted ventilatory assist in critically ill patients<br>* Other names: non-invasive ventilation;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in respiratory pattern |  | study duration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-invasive ventilation, diaphragm, electrical activity, neurally adjusted ventilatory assist, critically ill patients