Status:
UNKNOWN
VentFree: A Novel Abdominal Stimulator to Assist With Ventilator Weaning
Lead Sponsor:
Edward Hines Jr. VA Hospital
Collaborating Sponsors:
RML Specialty Hospital
Conditions:
COPD
Weaning Failure
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT02224352
Start Date
July 1 2014
End Date
March 1 2022
Last Update
August 17 2021
Active Locations (2)
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1
Edward G. Hines Jr., VA Hospital
Hines, Illinois, United States, 60141
2
RML Specialty Hospital
Hinsdale, Illinois, United States, 60521