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

NCT01337271 | Completed

• 1 other identifier: 2010-345
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Respiratory Failure

Keywords

artificial, ventilation; mechanical ventilation; weaning

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Extubation failure rate

  48 hours after extubation

Study Arms (2)

PSV

ACTIVE COMPARATOR

Procedure: SBT- PSV; Procedure: SBT - NAVA

NAVA

EXPERIMENTAL

Procedure: SBT- PSV; Procedure: SBT - NAVA

Interventions

SBT- PSV PROCEDURE

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

Also known as: SBT

NAVA; PSV

SBT - NAVA 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.

Also known as: NAVA, N.A.V.A.

NAVA; PSV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Respiratory ICU

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 29115949 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juliana C Ferreira, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: April 18, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 12, 2013

Record last verified: 2013-09

Locations

BR (1)