Recruiting

NAVA

Sponsor:

Boston Children's Hospital

Code:

NCT00814853

Conditions

Extubation

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

NAVA (Extubation readiness testing failures)

Study Details

Brief summary:

Neurally adjusted ventilatory assist (NAVA) is a FDA approved mode of mechanical ventilation. This mode of ventilation is currently in routine use in adult, pediatric and neonatal intensive care units. The electrical activity of the diaphragm, the largest muscle used during respiration, is measured. The ventilator applies support in proportion to the measured electrical activity of the diaphragm (Edi). This electrical activity is measured through a feeding tube that also has a multiple-array esophageal electrode in it.

Whenever a patient gets extubated in our MSICU, we conduct a routine extubation readiness test. This is standard of care in our ICU. If the patient fails this test, the patient stays on the ventilator. If he passes, he gets extubated. We wish to conduct a study during which we will monitor the electrical activity of the diaphragm during this test. If the patient passes the extubation readiness test, the study is complete. If he fails, he resumes on the ventilator. In our study, we would then use the measured signal of the diaphragm to guide the ventilator. This mode of ventilation is called NAVA. We do not currently use this mode of ventilation in the ICU, but could do so since it is FDA approved. However, we wish to use this protocol to gain more expertise with this mode of ventilation in the ICU in a controlled fashion. We wish to enroll 20 pediatric patients. Patients in the ICU are routinely on a variety of different models of ventilators. Usually, the respiratory therapist determines which ventilator will be used. All patients in this study would be on the Servo-I ventilator, which is an FDA approved ventilator and capable of monitoring electrical activity of the diaphragm and currently used in our MSICU.

Conditions

Extubation

Study ID

NCT00814853

Start date

Oct, 2008

Status verified date

Aug, 2009

Completion date

Mar, 2010

Anticipated

Primary completion date

Dec, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All intubated and mechanically ventilated patients age 1 month to 18 years and meeting the extubation readiness criterion.

Exclusion Criteria:

  • Patients in which a nasal gastric or oral gastric tube is contraindicated. Examples are but not limited to: s/p esophagus, tracheal surgery, bleeding disorders, facial trauma.

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

Extubation readiness testing

Patients who pass the ERT.

Interventions

NAVA (Extubation readiness testing failures)

Patients who fail the ERT will be place in the mode of ventilation NAVA.

Primary outcome measure

  • EDI pre and post extubation readiness testing. [ Time Frame: 2 hours ]

Central Contacts and Locations

Central contacts

Brian K Walsh, BS, MBA, RRT-NPS

617-935-7885brian.walsh@childrens.harvard.edu

Locations

Children's Hospital Boston

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Gerhard Wolf, MD

More Information

Sponsor

Boston Children's Hospital

Last update posted

Aug 4, 2009

Last verified

Aug, 2009

Keywords

  • Extubation
  • testing
  • ventilator weaning
  • Pediatric extubation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2009-08-04.