Electrical Activity of the Diaphragm During Extubation Readiness Testing (NAVA)
Recruitment status was Recruiting
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Purpose
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 |
|---|---|
|
Extubation |
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 |
- EDI pre and post extubation readiness testing. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
- Will the mode of ventilation NAVA wean the patient back to ERT settings. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
| 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
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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| Contact: Brian K Walsh, BS, MBA, RRT-NPS | 617-935-7885 | brian.walsh@childrens.harvard.edu |
| United States, Massachusetts | |
| Children's Hospital Boston | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Brian K Walsh, BS, MBA, RRT 617-935-7885 brian.walsh@childrens.harvard.edu | |
| 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 | Children's Hospital Boston |
More Information
No publications provided
| Responsible Party: | Gerhard Wolf, MD - Instructor, Children's Hospital Boston, Harvard Medical School |
| ClinicalTrials.gov Identifier: | NCT00814853 History of Changes |
| Other Study ID Numbers: | 08-07-0338, ERT |
| Study First Received: | December 24, 2008 |
| Last Updated: | August 3, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital Boston:
|
Extubation testing ventilator weaning Pediatric extubation |
ClinicalTrials.gov processed this record on May 23, 2013