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

NCT ID: NCT01337271

Last Updated: 2013-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-09-30

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.

Conditions

Respiratory Failure

Keywords

artificial, ventilation; mechanical ventilation; weaning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

PSV

Group Type: ACTIVE_COMPARATOR

SBT- PSV

Intervention Type: PROCEDURE

An Spontaneous breathing trial for 30 minutes on pressure support ventilation, which is a commonly used strategy to evaluate readiness for extubation

SBT - NAVA

Intervention Type: PROCEDURE

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.

NAVA

Group Type: EXPERIMENTAL

SBT- PSV

Intervention Type: PROCEDURE

An Spontaneous breathing trial for 30 minutes on pressure support ventilation, which is a commonly used strategy to evaluate readiness for extubation

SBT - NAVA

Intervention Type: PROCEDURE

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.

Interventions

SBT- PSV

An Spontaneous breathing trial for 30 minutes on pressure support ventilation, which is a commonly used strategy to evaluate readiness for extubation

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Other Intervention Names

SBT; NAVA; N.A.V.A.

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

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

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juliana C Ferreira, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Respiratory ICU

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 29115949 (View on PubMed)

Other Identifiers

2010-345

Identifier Type: -

Identifier Source: org_study_id