Electrical Activity of the Diaphragm During Extubation Readiness Testing (NAVA)
|ClinicalTrials.gov Identifier: NCT00814853|
Recruitment Status : Unknown
Verified August 2009 by Boston Children’s Hospital.
Recruitment status was: Recruiting
First Posted : December 25, 2008
Last Update Posted : August 4, 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 or disease||Intervention/treatment|
|Extubation||Device: NAVA (Extubation readiness testing failures)|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||25 participants|
|Observational Model:||Case Control|
|Official Title:||Electrical Activity of the Diaphragm During Extubation Readiness Testing|
|Study Start Date :||October 2008|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||March 2010|
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.
- EDI pre and post extubation readiness testing. [ Time Frame: 2 hours ]
- Will the mode of ventilation NAVA wean the patient back to ERT settings. [ Time Frame: 24 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814853
|Contact: Brian K Walsh, BS, MBA, RRT-NPSfirstname.lastname@example.org|
|United States, Massachusetts|
|Children's Hospital Boston||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Brian K Walsh, BS, MBA, RRT 617-935-7885 email@example.com|
|Principal Investigator: Gerhard Wolf, MD|
|Principal Investigator:||Gerhard Wolf, MD||Children's Hospital Boston, Harvard Medical School|
|Principal Investigator:||Brian K Walsh, BS, RRT-NPS||Boston Children’s Hospital|