Electric Stimulation, Respiration, Artificial, Ventilator Weaning
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBreath 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.
DEVICESham 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.
Sponsors
Liberate Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Maximum Expiratory Pressure From Baseline to Extubation | Change from baseline to first extubation, an expected average of 4 weeks | Maximum expiratory pressure was measured from total lung capacity |
| Change in Maximum Inspiratory Pressure From Baseline to Extubation | Change from baseline to first extubation, an expected average of 4 weeks | Maximum inspiratory pressure was measured from end expiratory lung volume. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Thickness of the Internal Oblique Muscle From Baseline to Extubation | Change from baseline to first extubation, an expected average of 4 weeks | Thickness of the internal oblique muscle as measured by ultrasound |
| Thickness of the Rectus Abdominis Muscle | Change from baseline to first extubation, an expected average of 4 weeks | Thickness of the rectus abdominis muscle as measured by ultrasound |
| Thickness of the Diaphragm | Change from baseline to first extubation, an expected average of 4 weeks | Thickness of the diaphragm as measured by ultrasound |
| Weaning Success | The earlier of 6 weeks or first extubation, an expected average of 4 weeks | Defined as free from ventilator support for more than 72 hours |
| Number of Days Taken to Wean | The earlier of 6 weeks or first extubation, an expected average of 4 weeks | — |
| Change in Thickness of the Transverse Abdominis Muscle From Baseline to Extubation | Change from baseline to first extubation, an expected average of 4 weeks | Thickness of transverse abdominis muscle as measured by ultrasound |
| 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 | Through study completion, an expected average of 4 weeks | Measured using the behavioral pain scale |
| Number of Adverse Events That Are Related to Treatment | Though study completion, an expected average of 4 weeks | This includes any adverse event that was graded as having a possible, probable or definite relationship to the study intervention. |
| Change in Cough Peak Flow From Baseline to Extubation | Change from baseline to first extubation, an expected average of 4 weeks | Cough peak flow was measured from total lung capacity |
| Change in Thickness of the External Oblique Muscle From Baseline to Extubation | Change from baseline to first extubation, an expected average of 4 weeks | Thickness of the external oblique muscle as measured by ultrasound |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| 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 |
| Total | 1 |
Baseline characteristics
| Characteristic | VentFree Stimulation | Total |
|---|---|---|
| Acute Physiology and Chronic Health Evaluation II (APACHE II) score | 13 units on a scale | 13 units on a scale |
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants |
| Cause of acute respiratory failure Other | 0 Participants | 0 Participants |
| Cause of acute respiratory failure Pneumonia | 1 Participants | 1 Participants |
| Duration of mechanical ventilation at enrollment | 18 Days | 18 Days |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Primary reason for mechanical ventilation Acute Respiratory Failure | 1 Participants | 1 Participants |
| Primary reason for mechanical ventilation Asthma | 0 Participants | 0 Participants |
| Primary reason for mechanical ventilation Coma | 0 Participants | 0 Participants |
| Primary reason for mechanical ventilation COPD | 0 Participants | 0 Participants |
| Primary reason for mechanical ventilation Neuromuscular Disease | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
| Tracheostomized Not Tracheostomized | 0 Participants | 0 Participants |
| Tracheostomized Tracheostomized | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 1 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
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
Population: No patients were enrolled in the sham arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VentFree Stimulation | Change in Maximum Expiratory Pressure From Baseline to Extubation | 2 cmH2O |
Primary
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
Population: No patients were enrolled in the sham arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VentFree Stimulation | Change in Maximum Inspiratory Pressure From Baseline to Extubation | 8 cmH2O |
Secondary
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
Population: No participants were enrolled in the sham group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VentFree Stimulation | Change in Cough Peak Flow From Baseline to Extubation | 21 Liters per minute |
Secondary
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
Population: No participants were enrolled in the sham group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VentFree Stimulation | Change in Spontaneous Minute Ventilation From Baseline to Final Study Visit | -1.2 liters per minute |
Secondary
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
Population: No participant were enrolled in the sham group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VentFree Stimulation | Change in Spontaneous Respiratory Rate From Baseline to Final Study Visit | -5 breaths per minute |
Secondary
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
Population: No participants were enrolled in the sham stimulation group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VentFree Stimulation | Change in Spontaneous Tidal Volume From Baseline to Final Visit or First Extubation | 150 milliliters |
Secondary
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
Population: This measurement was not collected due to equipment problems.
Secondary
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
Population: This measurement was not collected due to equipment problems.
Secondary
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
Population: This measurement was not collected due to equipment problems.
Secondary
Maximum Sensation of Stimulation Experienced by Patient
Measured using the behavioral pain scale
Time frame: Through study completion, an expected average of 4 weeks
Population: This measurement was not recorded.
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.
Time frame: Though study completion, an expected average of 4 weeks
Population: No participants enrolled in sham group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VentFree Stimulation | Number of Adverse Events That Are Related to Treatment | 1 events |
Secondary
Number of Days Taken to Wean
Time frame: The earlier of 6 weeks or first extubation, an expected average of 4 weeks
Population: No patients in the treatment group were successfully extubated from the ventilator. No patients were enrolled in the sham group
Secondary
Thickness of the Diaphragm
Thickness of the diaphragm as measured by ultrasound
Time frame: Change from baseline to first extubation, an expected average of 4 weeks
Population: This measurement was not collected due to equipment problems.
Secondary
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
Population: This measurement was not collected due to equipment problems.
Secondary
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
Population: No participants were enrolled in the sham group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VentFree Stimulation | Weaning Success | 0 Participants |