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

Not Applicable

Completed

• Conditions: Respiratory Failure
• Interventions: Procedure: SBT- PSV; Procedure: SBT - NAVA

• Registration Number: NCT01337271
• Lead Sponsor: University of Sao Paulo General Hospital

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2011-04-12
• Study First Submitted QC: 2011-04-15
• Study First Posted: 2011-04-18
• Study Start: 2011-05
• Status Verified: 2013-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2013-09-11
• Last Update Posted: 2013-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PSV	SBT- PSV	-
NAVA	SBT- PSV	-
PSV	SBT - NAVA	-
NAVA	SBT - NAVA	-

Primary Outcome Measures

Name	Time	Method
rate of success on the spontaneous breathing trial	30 minutes, or earlier (if the SBT is interrupted for intolerance), i.e., at the end of 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

Secondary Outcome Measures

Name	Time	Method
Extubation failure rate	48 hours after extubation	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

Trial Locations

Locations (1)

Respiratory ICU; 🇧🇷 Sao Paulo, Brazil