The primary objective of this study is to determine whether neuromuscular electrical stimulation applied to the abdominal wall muscles in synchrony with exhalation can increase the strength of the respiratory muscles in prolonged mechanical ventilation patients.
In the U.S. over 500,000 patients have difficulty weaning from mechanical ventilation every year. These patients cost the health care system $16 billion annually and have an increased risk of medical complications and morbidity. A major factor responsible for weaning failure is the imbalance between decreased respiratory muscle strength and excessive respiratory load. This study includes an investigational device that applies electrical stimulation to the abdominal muscles in synchrony with exhalation. This is hypothesized to improve the strength of the respiratory muscles. The long term goal of this project is to determine whether this approach can reduce the number of days taken for patients to wean from mechanical ventilation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2
VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.
Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.
Kindred Hospital
Louisville, Kentucky, United States
Change in Maximum Expiratory Pressure From Baseline to Extubation
Maximum expiratory pressure was measured from total lung capacity
Time frame: Change from baseline to first extubation, an expected average of 4 weeks
Change in Maximum Inspiratory Pressure From Baseline to Extubation
Maximum inspiratory pressure was measured from end expiratory lung volume.
Time frame: Change from baseline to first extubation, an expected average of 4 weeks
Change in Thickness of the Transverse Abdominis Muscle From Baseline to Extubation
Thickness of transverse abdominis muscle as measured by ultrasound
Time frame: Change from baseline to first extubation, an expected average of 4 weeks
Change in Thickness of the External Oblique Muscle From Baseline to Extubation
Thickness of the external oblique muscle as measured by ultrasound
Time frame: Change from baseline to first extubation, an expected average of 4 weeks
Change in Thickness of the Internal Oblique Muscle From Baseline to Extubation
Thickness of the internal oblique muscle as measured by ultrasound
Time frame: Change from baseline to first extubation, an expected average of 4 weeks
Thickness of the Rectus Abdominis Muscle
Thickness of the rectus abdominis muscle as measured by ultrasound
Time frame: Change from baseline to first extubation, an expected average of 4 weeks
Thickness of the Diaphragm
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Thickness of the diaphragm as measured by ultrasound
Time frame: Change from baseline to first extubation, an expected average of 4 weeks
Weaning Success
Defined as free from ventilator support for more than 72 hours
Time frame: The earlier of 6 weeks or first extubation, an expected average of 4 weeks
Number of Days Taken to Wean
Time frame: The earlier of 6 weeks or first extubation, an expected average of 4 weeks
Change in Cough Peak Flow From Baseline to Extubation
Cough peak flow was measured from total lung capacity
Time frame: Change from baseline to first extubation, an expected average of 4 weeks
Change in Spontaneous Tidal Volume From Baseline to Final Visit or First Extubation
Time frame: Change from baseline to final study visit or first extubation, an expected average of 4 weeks
Change in Spontaneous Respiratory Rate From Baseline to Final Study Visit
Time frame: Change from baseline to final study visit, an expected average of 4 weeks
Change in Spontaneous Minute Ventilation From Baseline to Final Study Visit
Time frame: Change from baseline to final study visit, an expected average of 4 weeks
Maximum Sensation of Stimulation Experienced by Patient
Measured using the behavioral pain scale
Time frame: Through study completion, an expected average of 4 weeks
Number of Adverse Events That Are Related to Treatment
This includes any adverse event that was graded as having a possible, probable or definite relationship to the study intervention.
Time frame: Though study completion, an expected average of 4 weeks