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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Children's Hospital Boston.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00814853
First received: December 24, 2008
Last updated: August 3, 2009
Last verified: August 2009
  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

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

Primary Outcome Measures:
  • EDI pre and post extubation readiness testing. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Study Population

Anyone eligible for and extubation readiness test.

Criteria

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 ClinicalTrials.gov identifier: NCT00814853

Contacts
Contact: Brian K Walsh, BS, MBA, RRT-NPS 617-935-7885 brian.walsh@childrens.harvard.edu

Locations
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         
Sponsors and Collaborators
Children's Hospital Boston
Investigators
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 September 18, 2014