VentFree: A Novel Abdominal Stimulator to Assist With Ventilator Weaning
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 2/13/2019 |
| Start Date: | July 2014 |
| End Date: | June 2019 |
| Contact: | Franco Laghi, MD |
| Email: | Franco.Laghi@va.gov |
| Phone: | 708/202-2705 |
Background: Over one million patients in the US are estimated to undergo mechanical
ventilation every year, and approximately 300,000 of them fail attempts at weaning. The
morbidity and mortality of these patients is greater than in patients who are successfully
weaned. It follows that treatments aimed at reducing the duration of mechanical ventilation
have the potential to benefit society both in terms of human suffering and cost.
Patients who fail attempts at weaning assist their inspiratory muscles during inhalation by
recruiting their expiratory muscles during exhalation. Unfortunately, this recruitment occurs
relatively late during a weaning trial. The knowledge that (a) expiratory muscle recruitment
can assist inspiration, (b) the recruitment of the expiratory muscles is delayed during
weaning, and (c) that the respiratory muscles in patients requiring mechanical ventilation
are in a catabolic state raises the possibility that strategies designed to produce an early
recruitment, and improve the strength, of the expiratory muscles could improve weaning
outcomes in difficult to wean patients.
The current investigation, which will be conducted in healthy subjects and in ambulatory
patients with chronic obstructive pulmonary disease (COPD) at Edward Hines Jr. VAH (Aims 1
and 2), and in patients who are difficult to wean from mechanical ventilation at RML
Specialty Hospital, Hinsdale, IL (Aim 3), has been designed to develop and assess a novel
triggering algorithm (VentFree), that controls the delivery of non-invasive neuro muscular
electrical stimulation (NMES) to the abdominal-wall muscles during exhalation, and to study
the physiological (respiratory) responses to such stimulation in assisting respiration in
healthy subjects, in ambulatory patients with COPD and in patients requiring pronged
mechanical ventilation.
ventilation every year, and approximately 300,000 of them fail attempts at weaning. The
morbidity and mortality of these patients is greater than in patients who are successfully
weaned. It follows that treatments aimed at reducing the duration of mechanical ventilation
have the potential to benefit society both in terms of human suffering and cost.
Patients who fail attempts at weaning assist their inspiratory muscles during inhalation by
recruiting their expiratory muscles during exhalation. Unfortunately, this recruitment occurs
relatively late during a weaning trial. The knowledge that (a) expiratory muscle recruitment
can assist inspiration, (b) the recruitment of the expiratory muscles is delayed during
weaning, and (c) that the respiratory muscles in patients requiring mechanical ventilation
are in a catabolic state raises the possibility that strategies designed to produce an early
recruitment, and improve the strength, of the expiratory muscles could improve weaning
outcomes in difficult to wean patients.
The current investigation, which will be conducted in healthy subjects and in ambulatory
patients with chronic obstructive pulmonary disease (COPD) at Edward Hines Jr. VAH (Aims 1
and 2), and in patients who are difficult to wean from mechanical ventilation at RML
Specialty Hospital, Hinsdale, IL (Aim 3), has been designed to develop and assess a novel
triggering algorithm (VentFree), that controls the delivery of non-invasive neuro muscular
electrical stimulation (NMES) to the abdominal-wall muscles during exhalation, and to study
the physiological (respiratory) responses to such stimulation in assisting respiration in
healthy subjects, in ambulatory patients with COPD and in patients requiring pronged
mechanical ventilation.
Aim 1 and Aim 2:Healthy Subjects and Ambulatory COPD Patients Studied at Hines VAH
Healthy subjects (Hines VAH), Inclusion criteria:
- Age ≥ 18 years
- No history of acute or chronic respiratory disease, cardiac or neuromuscular disease.
Ambulatory COPD patients (Hines VAH), Inclusion criteria:
- Age ≥ 18 years
- Chronic airway obstruction defined as forced expiratory volume in one second (FEV1) of
70% predicted or less, ratio of forced expiratory volume in one second to forced vital
capacity (FEV1/FVC) of 0.7 or less
- Stable clinical condition without an exacerbation during the preceding four weeks
Aim 3: Patients being weaned from prolonged mechanical ventilation (RML Specialty
Hospital), Inclusion criteria:
- Age ≥ 18 years
- History of neuromuscular disease
- Body mass index > 35 kg/m2
- Patients who have received mechanical ventilation for at least 14 days and the primary
physician judges the patient is ready to start weaning
- Able to breathe spontaneously for more than 5 minutes and less than 12 hours
- Clinically stable: oxygen saturation > 90% with a fractional inspired oxygen ≤ 0.40,
external PEEP ≤ 5 cm H2O, temperature ranging from 35.5 to 38.5Co, no intravenous
administration of vasoactive agents.
Additional inclusion/exclusion criteria for all potential participants
- Subjects with implanted electronic devices - such as cardiac pacemakers,
defibrillators and intrathecal pumps - will be excluded because NMES could cause
malfunction of those devices.
- Only subjects with intact abdominal-wall skin will be enrolled because NMES can cause
discomfort when applied over skin that is irritated or on open wounds.
- Pregnancy will be a contraindication to participate in the study because it is unknown
whether the application of NMES to the abdominal or lumbar area during pregnancy may
produce adverse effects.
- Unable to comprehend and interact in English.
We found this trial at
2
sites
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Hines, Illinois 60141
Principal Investigator: Franco Laghi, MD
Phone: 708-202-2705
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