Non-invasive Neurally Adjusted Ventilatory Assist

NCT ID: NCT01280383

Last Updated: 2015-07-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2015-05-31

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

Conditions

Respiratory Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

non-invasive NAVA

application of non-invasive NAVA in critically ill patients

Group Type: EXPERIMENTAL

non-invasive neurally adjusted ventilatory assist

Intervention Type: DEVICE

non-invasive neurally adjusted ventilatory assist in critically ill patients

Interventions

non-invasive neurally adjusted ventilatory assist

non-invasive neurally adjusted ventilatory assist in critically ill patients

Intervention Type: DEVICE

Other Intervention Names

neurally adjusted ventilatory assist; non-invasive ventilation

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lukas Brander, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital (Inselspital) and University of Bern

References

Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindstrom L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. doi: 10.1038/71012. No abstract available.

Reference Type: BACKGROUND

PMID: 10581089 (View on PubMed)

Other Identifiers

BE KEK 123/10

Identifier Type: -

Identifier Source: org_study_id