Electrical Activity of the Diaphragm During Extubation Readiness Testing

NCT00814853 | Unknown DMC

• 2 other identifiers: 08-07-0338ERT
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

Extubation; testing; ventilator weaning; Pediatric extubation

Outcome Measures

Primary Outcomes (1)

• EDI pre and post extubation readiness testing.

  2 hours

Secondary Outcomes (1)

• Will the mode of ventilation NAVA wean the patient back to ERT settings.

  24 hours

Study Arms (1)

Extubation readiness testing

Patients who pass the ERT.

Device: NAVA (Extubation readiness testing failures)

Interventions

NAVA (Extubation readiness testing failures) DEVICE

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

Extubation readiness testing

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Anyone eligible for and extubation readiness test.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

RECRUITING

Study Officials

• Gerhard Wolf, MD

  Children's Hospital Boston, Harvard Medical School

  PRINCIPAL INVESTIGATOR

• Brian K Walsh, BS, RRT-NPS

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian K Walsh, BS, MBA, RRT-NPS

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 24, 2008
• First Posted: December 25, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: March 1, 2010
• Last Updated: August 4, 2009

Record last verified: 2009-08

Locations

US (1)