Clinical trial NCT01337271: Performance of Neurally Adjusted Ventilatory Assist (NAVA) During Spontaneous Breathing Trial
Official title: Performance of Neurally Adjusted Ventilatory Assist (NAVA) During an Spontaneous Breathing Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Keywords: artificial, ventilation
mechanical ventilation
weaning
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2011-04-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: rate of success on the spontaneous breathing trial
timeFrame: 30 minutes, or earlier (if the SBT is interrupted for intolerance), i.e., at the end of the spontaneous breathing trial
Secondary outcomes:
measure: Extubation failure rate
timeFrame: 48 hours after extubation
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Respiratory ICU
Study officials:
affiliation: University of Sao Paulo
name: Juliana C Ferreira, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferreira JC, Diniz-Silva F, Moriya HT, Alencar AM, Amato MBP, Carvalho CRR. Neurally Adjusted Ventilatory Assist (NAVA) or Pressure Support Ventilation (PSV) during spontaneous breathing trials in critically ill patients: a crossover trial. BMC Pulm Med. 2017 Nov 7;17(1):139. doi: 10.1186/s12890-017-0484-5.