Respiration, Artificial Clinical Trial
Official title:
Breath Synchronized Abdominal Muscle Stimulation to Facilitate Ventilator Weaning: a Pilot
Verified date | October 2021 |
Source | Liberate Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 2 |
Est. completion date | April 6, 2017 |
Est. primary completion date | April 6, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients who have been mechanically ventilated for at least fourteen days. - Clinically stable: oxygen saturation > 90% with a fractional inspired oxygen = 0.40, external positive end expiratory pressure = 5 centimeters water, temperature ranging from 35.5 to 38.5 degrees celsius, no intravenous administration of vasoactive agents. Exclusion Criteria: - Patients in whom Neuromuscular Electrical Stimulation (NMES) does not elicit a palpable contraction of the abdominal muscles. - Patients with broken or irritated skin on the abdominal wall - Patients with a history of neuromuscular disease - Body Mass Index (BMI) > 35 kg/m2 - Patients who are not medically stable - Patients with a pacemaker - Female patients who are pregnant - Patients under the age of 18 - Patients who are expected to die within four weeks - Patients who are unable to follow verbal instructions - Patients with epilepsy - Patients with an abdominal wall hernia - Patients with anoxic encephalopathy - Patients with history of, or active, substance abuse |
Country | Name | City | State |
---|---|---|---|
United States | Kindred Hospital | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Liberate Medical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Maximum Expiratory Pressure From Baseline to Extubation | Maximum expiratory pressure was measured from total lung capacity | Change from baseline to first extubation, an expected average of 4 weeks | |
Primary | Change in Maximum Inspiratory Pressure From Baseline to Extubation | Maximum inspiratory pressure was measured from end expiratory lung volume. | Change from baseline to first extubation, an expected average of 4 weeks | |
Secondary | Change in Thickness of the Transverse Abdominis Muscle From Baseline to Extubation | Thickness of transverse abdominis muscle as measured by ultrasound | Change from baseline to first extubation, an expected average of 4 weeks | |
Secondary | Change in Thickness of the External Oblique Muscle From Baseline to Extubation | Thickness of the external oblique muscle as measured by ultrasound | Change from baseline to first extubation, an expected average of 4 weeks | |
Secondary | Change in Thickness of the Internal Oblique Muscle From Baseline to Extubation | Thickness of the internal oblique muscle as measured by ultrasound | Change from baseline to first extubation, an expected average of 4 weeks | |
Secondary | Thickness of the Rectus Abdominis Muscle | Thickness of the rectus abdominis muscle as measured by ultrasound | Change from baseline to first extubation, an expected average of 4 weeks | |
Secondary | Thickness of the Diaphragm | Thickness of the diaphragm as measured by ultrasound | Change from baseline to first extubation, an expected average of 4 weeks | |
Secondary | Weaning Success | Defined as free from ventilator support for more than 72 hours | The earlier of 6 weeks or first extubation, an expected average of 4 weeks | |
Secondary | Number of Days Taken to Wean | The earlier of 6 weeks or first extubation, an expected average of 4 weeks | ||
Secondary | Change in Cough Peak Flow From Baseline to Extubation | Cough peak flow was measured from total lung capacity | Change from baseline to first extubation, an expected average of 4 weeks | |
Secondary | Change in Spontaneous Tidal Volume From Baseline to Final Visit or First Extubation | Change from baseline to final study visit or first extubation, an expected average of 4 weeks | ||
Secondary | Change in Spontaneous Respiratory Rate From Baseline to Final Study Visit | Change from baseline to final study visit, an expected average of 4 weeks | ||
Secondary | Change in Spontaneous Minute Ventilation From Baseline to Final Study Visit | Change from baseline to final study visit, an expected average of 4 weeks | ||
Secondary | Maximum Sensation of Stimulation Experienced by Patient | Measured using the behavioral pain scale | Through study completion, an expected average of 4 weeks | |
Secondary | 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. | Though study completion, an expected average of 4 weeks |
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