Non-invasive Neurally Adjusted Ventilatory Assist

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01280383
• Other study ID #: BE KEK 123/10
• Status: Withdrawn
• Phase: Phase 1
• First received: January 10, 2011
• Last updated: July 22, 2015
• Start date: November 2010
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• non-invasive neurally adjusted ventilatory assist
non-invasive neurally adjusted ventilatory assist in critically ill patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

References & Publications (1)

Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindström L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient-ventilator synchrony		outcomes are assessed at the end of each experimental period, i.e. every 20-30 minutes	No
Secondary	changes in respiratory pattern		study duration	No