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

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
SBT- PSV
SBT - NAVA
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Respiratory Failure focused on measuring artificial, ventilation, mechanical ventilation, weaning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Respiratory ICU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PSV

NAVA

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 12, 2011
Last Updated
September 11, 2013
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01337271
Brief Title
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

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
artificial, ventilation, mechanical ventilation, weaning

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PSV
Arm Type
Active Comparator
Arm Title
NAVA
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
SBT- PSV
Other Intervention Name(s)
SBT
Intervention Description
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
Intervention Name(s)
SBT - NAVA
Other Intervention Name(s)
NAVA, N.A.V.A.
Intervention Description
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.
Primary Outcome Measure Information:
Title
rate of success on the spontaneous breathing trial
Description
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
Time Frame
30 minutes, or earlier (if the SBT is interrupted for intolerance), i.e., at the end of the spontaneous breathing trial
Secondary Outcome Measure Information:
Title
Extubation failure rate
Description
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
Time Frame
48 hours after extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliana C Ferreira, MD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Respiratory ICU
City
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
29115949
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.
Results Reference
derived

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

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