Non-invasive Neurally Adjusted Ventilatory Assist

Phase 1

Withdrawn

• Conditions: Respiratory Failure
• Interventions: Device: non-invasive neurally adjusted ventilatory assist

• Registration Number: NCT01280383
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-19
• Study First Posted: 2011-01-20
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-22
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
non-invasive NAVA	non-invasive neurally adjusted ventilatory assist	application of non-invasive NAVA in critically ill patients

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
changes in respiratory pattern	study duration