Trial Outcomes & Findings for Breath Synchronized Abdominal Muscle Stimulation to Facilitate Ventilator Weaning: a Pilot Study (NCT NCT03019107)

NCT ID: NCT03019107

Last Updated: 2021-11-08

Results Overview

Maximum expiratory pressure was measured from total lung capacity

Recruitment status

TERMINATED

Target enrollment

2 participants

Primary outcome timeframe

Change from baseline to first extubation, an expected average of 4 weeks

Results posted on

2021-11-08

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Breath Synchronized Abdominal Muscle Stimulation to Facilitate Ventilator Weaning: a Pilot Study

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Change from baseline to first extubation, an expected average of 4 weeks

Population: No patients were enrolled in the sham arm

Maximum expiratory pressure was measured from total lung capacity

Outcome measures

Outcome measures
Measure	VentFree Stimulation n=1 Participants 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.	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.
Change in Maximum Expiratory Pressure From Baseline to Extubation	2 cmH2O	—

PRIMARY outcome

Timeframe: Change from baseline to first extubation, an expected average of 4 weeks

Population: No patients were enrolled in the sham arm

Maximum inspiratory pressure was measured from end expiratory lung volume.

Outcome measures

Outcome measures
Measure	VentFree Stimulation n=1 Participants 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.	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.
Change in Maximum Inspiratory Pressure From Baseline to Extubation	8 cmH2O	—

SECONDARY outcome

Timeframe: Change from baseline to first extubation, an expected average of 4 weeks

Population: This measurement was not collected due to equipment problems.

Thickness of transverse abdominis muscle as measured by ultrasound

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to first extubation, an expected average of 4 weeks

Population: This measurement was not collected due to equipment problems.

Thickness of the external oblique muscle as measured by ultrasound

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to first extubation, an expected average of 4 weeks

Population: This measurement was not collected due to equipment problems.

Thickness of the internal oblique muscle as measured by ultrasound

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to first extubation, an expected average of 4 weeks

Population: This measurement was not collected due to equipment problems.

Thickness of the rectus abdominis muscle as measured by ultrasound

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to first extubation, an expected average of 4 weeks

Population: This measurement was not collected due to equipment problems.

Thickness of the diaphragm as measured by ultrasound

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: The earlier of 6 weeks or first extubation, an expected average of 4 weeks

Population: No participants were enrolled in the sham group

Defined as free from ventilator support for more than 72 hours

Outcome measures

Outcome measures
Measure	VentFree Stimulation n=1 Participants 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.	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.
Weaning Success	0 Participants	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to first extubation, an expected average of 4 weeks

Population: No participants were enrolled in the sham group

Cough peak flow was measured from total lung capacity

Outcome measures

Outcome measures
Measure	VentFree Stimulation n=1 Participants 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.	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.
Change in Cough Peak Flow From Baseline to Extubation	21 Liters per minute	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	VentFree Stimulation n=1 Participants 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.	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.
Change in Spontaneous Tidal Volume From Baseline to Final Visit or First Extubation	150 milliliters	—

SECONDARY outcome

Timeframe: Change from baseline to final study visit, an expected average of 4 weeks

Population: No participant were enrolled in the sham group

Outcome measures

Outcome measures
Measure	VentFree Stimulation n=1 Participants 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.	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.
Change in Spontaneous Respiratory Rate From Baseline to Final Study Visit	-5 breaths per minute	—

SECONDARY outcome

Timeframe: Change from baseline to final study visit, an expected average of 4 weeks

Population: No participants were enrolled in the sham group

Outcome measures

Outcome measures
Measure	VentFree Stimulation n=1 Participants 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.	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.
Change in Spontaneous Minute Ventilation From Baseline to Final Study Visit	-1.2 liters per minute	—

SECONDARY outcome

Timeframe: Through study completion, an expected average of 4 weeks

Population: This measurement was not recorded.

Measured using the behavioral pain scale

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Though study completion, an expected average of 4 weeks

Population: No participants enrolled in sham group

This includes any adverse event that was graded as having a possible, probable or definite relationship to the study intervention.

Outcome measures

Outcome measures
Measure	VentFree Stimulation n=1 Participants 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.	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.
Number of Adverse Events That Are Related to Treatment	1 events	—

Adverse Events

VentFree Stimulation

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sham Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	VentFree Stimulation n=1 participants at risk 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.	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.
Cardiac disorders Mean arterial pressure	100.0% 1/1 • Number of events 1 • 6 weeks Adverse events were reviewed during every study intervention session	— 0/0 • 6 weeks Adverse events were reviewed during every study intervention session
Respiratory, thoracic and mediastinal disorders Dyspnea	100.0% 1/1 • Number of events 1 • 6 weeks Adverse events were reviewed during every study intervention session	— 0/0 • 6 weeks Adverse events were reviewed during every study intervention session
Musculoskeletal and connective tissue disorders Abdominal muscle soreness	100.0% 1/1 • Number of events 1 • 6 weeks Adverse events were reviewed during every study intervention session	— 0/0 • 6 weeks Adverse events were reviewed during every study intervention session

Additional Information

Angus Mclachlan

Liberate Medical

Phone: +1 (833) 203-4663

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	VentFree Stimulation n=1 Participants 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.	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.	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Duration of mechanical ventilation at enrollment	18 Days n=5 Participants	—	18 Days n=5 Participants
Primary reason for mechanical ventilation Acute Respiratory Failure	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Primary reason for mechanical ventilation Coma	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Primary reason for mechanical ventilation COPD	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Primary reason for mechanical ventilation Asthma	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Primary reason for mechanical ventilation Neuromuscular Disease	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Cause of acute respiratory failure Pneumonia	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Cause of acute respiratory failure Other	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Acute Physiology and Chronic Health Evaluation II (APACHE II) score	13 units on a scale n=5 Participants	—	13 units on a scale n=5 Participants
Tracheostomized Tracheostomized	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Tracheostomized Not Tracheostomized	0 Participants n=5 Participants	—	0 Participants n=5 Participants