Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation

Prospective, Single-center, Randomized Clinical Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation

This study is a randomized prospective, single-center feasibility study of the use and benefits of NeuRx DPS in patients undergoing tracheostomy for failure to wean.

15 patients undergoing tracheostomy for failure to wean will be randomized into one of 3 cohorts (5 in each cohort): Cohort A: tracheostomy with no intervention; Cohort B: tracheostomy with DPS implantation and immediate stimulation and monitoring and Cohort C: tracheostomy with DPS implantation with monitoring followed with stimulation on day 5.

Inclusion Criteria:

• Patient is intubated, on mechanical ventilation, undergoing tracheostomy, and expected to undergo mechanical ventilation for at least 5 days
• Signed written informed consent has been obtained prior to performing any study related procedure(s)
• Subject is at least 18 years of age
• Negative pregnancy test if the patient is a female of child-bearing potential. (Females of child-bearing potential exclude women who are post-hysterectomy or post-menopausal.)

Exclusion Criteria:

• Diaphragm malformation which makes electrode insertion impossible
• Presence of an implantable cardioverter-defibrillator
• Severe chronic obstructive pulmonary disease (COPD)
• Subject is pregnant or breastfeeding
• Diagnosis of neuromuscular disease or high level spinal cord injury prior to tracheostomy
• Terminal patients expected to die during their stay in the hospital
• Participation in other clinical studies that could interfere with the results in the ongoing study