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Electrical Activity of the Diaphragm During Extubation Readiness Testing (NAVA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Boston Children’s Hospital.
Recruitment status was:  Recruiting
Information provided by:
Boston Children’s Hospital Identifier:
First received: December 24, 2008
Last updated: August 3, 2009
Last verified: August 2009

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.

Condition Intervention
Device: NAVA (Extubation readiness testing failures)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Electrical Activity of the Diaphragm During Extubation Readiness Testing

Further study details as provided by Boston Children’s Hospital:

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

Secondary Outcome Measures:
  • Will the mode of ventilation NAVA wean the patient back to ERT settings. [ Time Frame: 24 hours ]

Estimated Enrollment: 25
Study Start Date: October 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Extubation readiness testing
Patients who pass the ERT.
Device: NAVA (Extubation readiness testing failures)
Patients who fail the ERT will be place in the mode of ventilation NAVA.

  Show Detailed Description


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Anyone eligible for and extubation readiness test.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00814853

Contact: Brian K Walsh, BS, MBA, RRT-NPS 617-935-7885

United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Brian K Walsh, BS, MBA, RRT    617-935-7885   
Principal Investigator: Gerhard Wolf, MD         
Sponsors and Collaborators
Boston Children’s Hospital
Principal Investigator: Gerhard Wolf, MD Children's Hospital Boston, Harvard Medical School
Principal Investigator: Brian K Walsh, BS, RRT-NPS Boston Children’s Hospital
  More Information

Responsible Party: Gerhard Wolf, MD - Instructor, Children's Hospital Boston, Harvard Medical School Identifier: NCT00814853     History of Changes
Other Study ID Numbers: 08-07-0338
Study First Received: December 24, 2008
Last Updated: August 3, 2009

Keywords provided by Boston Children’s Hospital:
ventilator weaning
Pediatric extubation processed this record on May 25, 2017