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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VentFree Stimulation | Experimental | Breath synchronized abdominal NMES |
|
| Sham Stimulation | Sham Comparator | Sham breath synchronized abdominal NMES |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breath synchronized abdominal NMES | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Thickness of the External Oblique Muscle From Baseline to Extubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kindred Hospital | Louisville | Kentucky | 40204 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | VentFree Stimulation | Breath synchronized abdominal NMES Breath synchronized abdominal NMES: 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. |
| FG001 | Sham Stimulation | Sham breath synchronized abdominal NMES Sham breath synchronized abdominal NMES: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No participants were enrolled in the control group as the trial was terminated after the first patient was enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | VentFree Stimulation | Breath synchronized abdominal NMES Breath synchronized abdominal NMES: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Maximum Expiratory Pressure From Baseline to Extubation | Maximum expiratory pressure was measured from total lung capacity | No patients were enrolled in the sham arm | Posted | Number | cmH2O | Change from baseline to first extubation, an expected average of 4 weeks |
|
6 weeks
Adverse events were reviewed during every study intervention session
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VentFree Stimulation | Breath synchronized abdominal NMES Breath synchronized abdominal NMES: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mean arterial pressure | Cardiac disorders | Systematic Assessment | Mean arterial pressure was elevated to 128 mmHg prior to initiation of treatment. Adverse event was assessed with Moderate severity, no relationship with study device, and was resolved with no sequel. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angus Mclachlan | Liberate Medical | +1 (833) 203-4663 | info@liberatemedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2016 | Oct 11, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
|
| Sham breath synchronized abdominal NMES | Device | 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. |
|
Thickness of the external oblique muscle as measured by ultrasound |
| 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 | 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 | Change from baseline to first extubation, an expected average of 4 weeks |
| Thickness of the Diaphragm | Thickness of the diaphragm as measured by ultrasound | 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 | The earlier of 6 weeks or first extubation, an expected average of 4 weeks |
| Number of Days Taken to Wean | 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 | 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 | 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 | Change from baseline to final study visit, an expected average of 4 weeks |
| Change in Spontaneous Minute Ventilation From Baseline to Final Study Visit | 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 | 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. | Though study completion, an expected average of 4 weeks |
| BG001 | Sham Stimulation | Sham breath synchronized abdominal NMES Sham breath synchronized abdominal NMES: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Duration of mechanical ventilation at enrollment | Number | Days |
|
| Primary reason for mechanical ventilation | Count of Participants | Participants |
|
| Cause of acute respiratory failure | Count of Participants | Participants |
|
| Acute Physiology and Chronic Health Evaluation II (APACHE II) score | The APACHE II score is a widely used ICU prognostic scale that is a measurement of patient disease severity and strongly correlates with patient outcomes. The APACHE II is an integer score from 0 to 71; higher scores correspond to more severe disease and a higher risk of death. | Number | units on a scale |
|
| Tracheostomized | Count of Participants | Participants |
|
| OG001 | Sham Stimulation | Sham breath synchronized abdominal NMES Sham breath synchronized abdominal NMES: 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. |
|
|
| Primary | Change in Maximum Inspiratory Pressure From Baseline to Extubation | Maximum inspiratory pressure was measured from end expiratory lung volume. | No patients were enrolled in the sham arm | Posted | Number | cmH2O | 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 | This measurement was not collected due to equipment problems. | Posted | 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 | This measurement was not collected due to equipment problems. | Posted | 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 | This measurement was not collected due to equipment problems. | Posted | 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 | This measurement was not collected due to equipment problems. | Posted | 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 | This measurement was not collected due to equipment problems. | Posted | 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 | No participants were enrolled in the sham group | Posted | Count of Participants | Participants | The earlier of 6 weeks or first extubation, an expected average of 4 weeks |
|
|
|
| Secondary | Number of Days Taken to Wean | No patients in the treatment group were successfully extubated from the ventilator. No patients were enrolled in the sham group | Posted | 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 | No participants were enrolled in the sham group | Posted | Number | Liters per minute | 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 | No participants were enrolled in the sham stimulation group. | Posted | Number | milliliters | Change from baseline to final study visit or first extubation, an expected average of 4 weeks |
|
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|
| Secondary | Change in Spontaneous Respiratory Rate From Baseline to Final Study Visit | No participant were enrolled in the sham group | Posted | Number | breaths per minute | Change from baseline to final study visit, an expected average of 4 weeks |
|
|
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| Secondary | Change in Spontaneous Minute Ventilation From Baseline to Final Study Visit | No participants were enrolled in the sham group | Posted | Number | liters per minute | 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 | This measurement was not recorded. | Posted | 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. | No participants enrolled in sham group | Posted | Number | events | Though study completion, an expected average of 4 weeks |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Sham Stimulation | Sham breath synchronized abdominal NMES Sham breath synchronized abdominal NMES: 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. | 0 | 0 | 0 | 0 | 0 | 0 |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Adverse event was assessed with Moderate severity and unrelated to study intervention. Resolved with no sequel. |
|
| Abdominal muscle soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Adverse event was rated with Mild severity and Definitely related to study intervention. Resolved with no sequel |
|
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