Electric StimulationNCT03019107
Breath Synchronized Abdominal Muscle Stimulation to Facilitate Ventilator Weaning: a Pilot Study
A study testing Breath synchronized abdominal NMES in people with Electric Stimulation and Respiration, Artificial, run by Liberate Medical at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electric Stimulation, Respiration, Artificial, Ventilator Weaning
- What is being tested?
- Breath synchronized abdominal NMES
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2017to 6 Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breath Synchronized Abdominal Muscle Stimulation to Facilitate Ventilator Weaning: a Pilot
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.
Read the 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.
- Being tested
- Breath synchronized abdominal NMES, Sham breath synchronized abdominal NMES
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath synchronized abdominal NMESDevice
Also called VentFree
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 breath synchronized abdominal NMESDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| VentFree Stimulation | Experimental | Breath synchronized abdominal NMES Receives: Device: Breath synchronized abdominal NMES |
| Sham Stimulation | Sham comparator | Sham breath synchronized abdominal NMES Receives: Device: Sham breath synchronized abdominal NMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximum Expiratory Pressure From Baseline to Extubation
Maximum expiratory pressure was measured from total lung capacity
Measured: 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.
Measured: Change from baseline to first extubation, an expected average of 4 weeks
Secondary outcomes (13)
Change in Thickness of the Transverse Abdominis Muscle From Baseline to Extubation
Thickness of transverse abdominis muscle as measured by ultrasound
Measured: Change from baseline to first extubation, an expected average of 4 weeks
Change in Thickness of the External Oblique Muscle From Baseline to Extubation
Thickness of the external oblique muscle as measured by ultrasound
Measured: 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
Measured: 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
Measured: Change from baseline to first extubation, an expected average of 4 weeks
Thickness of the Diaphragm
Thickness of the diaphragm as measured by ultrasound
Measured: 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
Measured: The earlier of 6 weeks or first extubation, an expected average of 4 weeks
Number of Days Taken to Wean
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline to final study visit, an expected average of 4 weeks
Change in Spontaneous Minute Ventilation From Baseline to Final Study Visit
Measured: 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
Measured: 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.
Measured: Though study completion, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study start22 Feb 2017
- Primary completion6 Apr 2017
- Study completion6 Apr 2017
Why it stopped: Unable to meet enrollment goal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Electric StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liberate Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019107
- Sponsor's protocol ID
- LM-KINDRED-01
- Status last verified
- Oct 2021
- First submitted
- 13 Dec 2016
- Last updated
- 8 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breath Synchronized Abdominal Muscle Stimulation to Facilitate Ventilator Weaning: a Pilot
- ClinicalTrials.gov ID
- NCT03019107
- Acronym / sponsor ID
- LM-KINDRED-01
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to meet enrollment goal
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Liberate MedicalIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 6 Apr 2017 (actual)
- Study completion
- 6 Apr 2017 (actual)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Posted 8 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VentFree Stimulation | Experimental | Device: Breath synchronized abdominal NMESBreath synchronized abdominal NMES |
| Sham Stimulation | Sham comparator | Device: Sham breath synchronized abdominal NMESSham breath synchronized abdominal NMES |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath synchronized abdominal NMESAlso: VentFreeVentFree 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. | Device | VentFree Stimulation |
| Sham breath synchronized abdominal NMESModified 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. | Device | Sham Stimulation |
Primary outcome
Change in Maximum Expiratory Pressure From Baseline to Extubation
Time frame: 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
Time frame: Change from baseline to first extubation, an expected average of 4 weeks
Maximum inspiratory pressure was measured from end expiratory lung volume.
13 secondary outcomes
Change in Thickness of the Transverse Abdominis Muscle From Baseline to Extubation
Time frame: Change from baseline to first extubation, an expected average of 4 weeks
Change in Thickness of the External Oblique Muscle From Baseline to Extubation
Time frame: Change from baseline to first extubation, an expected average of 4 weeks
Change in Thickness of the Internal Oblique Muscle From Baseline to Extubation
Time frame: Change from baseline to first extubation, an expected average of 4 weeks
Thickness of the Rectus Abdominis Muscle
Time frame: Change from baseline to first extubation, an expected average of 4 weeks
Thickness of the Diaphragm
Time frame: Change from baseline to first extubation, an expected average of 4 weeks
Weaning Success
Time frame: The earlier of 6 weeks or first extubation, an expected average of 4 weeks
Number of Days Taken to Wean
Time frame: The earlier of 6 weeks or first extubation, an expected average of 4 weeks
Change in Cough Peak Flow From Baseline to Extubation
Time frame: 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
Time frame: 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
Time frame: Change from baseline to final study visit, an expected average of 4 weeks
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
Maximum Sensation of Stimulation Experienced by Patient
Time frame: Through study completion, an expected average of 4 weeks
Number of Adverse Events That Are Related to Treatment
Time frame: Though study completion, an expected average of 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath synchronized abdominal NMES in people with Electric Stimulation and Respiration, Artificial, run by Liberate Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maximum Expiratory Pressure From Baseline to Extubation (time frame: Change from baseline to first extubation, an expected average of 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.