Performance of Neurally Adjusted Ventilatory Assist (NAVA) During Spontaneous Breathing Trial

Respiratory Failure Clinical Trial

Official title:

Performance of Neurally Adjusted Ventilatory Assist (NAVA) During an Spontaneous Breathing Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01337271
• Other study ID #: 2010-345
• Status: Completed
• Phase: N/A
• First received: April 12, 2011
• Last updated: September 11, 2013
• Start date: May 2011
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare a new mode of mechanical ventilation (NAVA, or Neurally adjusted Ventilatory assist) with a traditional mode (Pressure Support ventilation) on its the ability to detect patients ready for extubation (liberation from mechanical ventilation).

Description:

Patients under mechanical ventilation who are suspected to be recovered and ready to return to spontaneous ventilation often undergo an spontaneous breathing trial (SBT) before extubation and liberation from mechanical ventilation. During the test, which lasts from 30 minutes to 2 hours , the patient receives minimal support from the ventilator, and the ICU team observes if the patient develops any signs or symptoms of discomfort or respiratory distress. If the patient tolerates the test, he or she is considered ready for extubation. The Neurally Adjusted Ventilatory Assist (NAVA) is a new mode of ventilation, shown to improve patient-ventilator synchrony. It has not been tested during SBTs. Our objective is to compare the performance of NAVA with the commonly used Pressure Support ventilation, during an SBT. Patients considered to be ready for an SBT by the ICU team will undergo two SBTs in random order: one in pressure support, and the other on NAVA, with a 1-hour interval between the tests. Ventilatory parameters and patient-ventilator interaction variables will be compared among the two tests.

This study will help us understand if NAVA can be used during an SBT, which might be important for patients who are being ventilated with NAVA before the SBT is suggested, especially those how present a high asynchrony rate when ventilated with Pressure Support Mode.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• mechanical ventilation for more than 48 hours

• Considered ready for an spontaneous breathing trial by the ICU team

• informed consent for participation on the study signed by a family member

Exclusion Criteria:

• age < 18yrs

• pregnancy

• facial trauma or burns that might interfere with the esophageal catheter placement

• nasal pathologies that prevent adequate placement of the catheter

• esophageal varices or gastroesophageal bleeding in the past 30 days

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Screening

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Procedure:
• SBT- PSV
An Spontaneous breathing trial for 30 minutes on pressure support ventilation, which is a commonly used strategy to evaluate readiness for extubation
• SBT - NAVA
An spontaneous breathing trial (SBT) on the ventilatory mode NAVA, with ventilatory support titrated to be similar to the support provided during an SBT on pressure support mode (PSV). NAVA captures the electrical activity of the diaphragm with an esophageal-gastric catheter, and uses the electrical signal to deliver inspiratory pressure proportional to the intensity of patient effort, as well as to trigger and cycle assisted mechanical breaths.

Locations

Country	Name	City	State
Brazil	Respiratory ICU	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of success on the spontaneous breathing trial	The ICU team will observe the patient during the spontaneous breathing trial, and use standard objective (blood gases) and subjective (including respiratory rate, tidal volume, comfort, hemodynamic variables) variables to determine if the patient tolerates the SBT and therefore is ready for discontinuation from mechanical ventilation	30 minutes, or earlier (if the SBT is interrupted for intolerance), i.e., at the end of the spontaneous breathing trial	No
Secondary	Extubation failure rate	Patients who are extubated within 24 hours of the completion of the study will be followed for 48h, and if re-intubation is required within these first 48h after the extubation, the investigators will consider that the patient had extubation failure	48 hours after extubation	No