COPDNCT02224352
VentFree: A Novel Abdominal Stimulator to Assist With Ventilator Weaning
A study testing Functional neuromuscular electrical stimulation in people with COPD and Weaning Failure, run by Edward Hines Jr. VA Hospital at 2 sites in United States.
Trial summary
Background: Over one million patients in the US are estimated to undergo mechanical ventilation every year, and approximately 300,000 of them fail attempts at weaning. The morbidity and mortality of these patients is greater than in patients who are successfully weaned. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD, Weaning Failure
- What is being tested?
- Functional neuromuscular electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Aim 1 and Aim 2:Healthy Subjects and Ambulatory COPD Patients Studied at Hines VAH
Healthy subjects (Hines VAH), Inclusion criteria:
- Age ≥ 18 years
- No history of acute or chronic respiratory disease, cardiac or neuromuscular disease.
Ambulatory COPD patients (Hines VAH), Inclusion criteria:
- Age ≥ 18 years
- Chronic airway obstruction defined as forced expiratory volume in one second (FEV1) of 70% predicted or less, ratio of forced expiratory volume in one second to forced vital capacity (FEV1/FVC) of 0.7 or less
- Stable clinical condition without an exacerbation during the preceding four weeks
Aim 3: Patients being weaned from prolonged mechanical ventilation (RML Specialty Hospital), Inclusion criteria:
- Age ≥ 18 years
- History of neuromuscular disease
- Body mass index > 35 kg/m2
- Patients who have received mechanical ventilation for at least 14 days and the primary physician judges the patient is ready to start weaning
- Able to breathe spontaneously for more than 5 minutes and less than 12 hours
- Clinically stable: oxygen saturation > 90% with a fractional inspired oxygen ≤ 0.40, external PEEP ≤ 5 cm H2O, temperature ranging from 35.5 to 38.5Co, no intravenous administration of vasoactive agents.
Additional inclusion/exclusion criteria for all potential participants
- Subjects with implanted electronic devices - such as cardiac pacemakers, defibrillators and intrathecal pumps - will be excluded because NMES could cause malfunction of those devices.
- Only subjects with intact abdominal-wall skin will be enrolled because NMES can cause discomfort when applied over skin that is irritated or on open wounds.
- Pregnancy will be a contraindication to participate in the study because it is unknown whether the application of NMES to the abdominal or lumbar area during pregnancy may produce adverse effects.
- Unable to comprehend and interact in English.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Edward G. Hines Jr., VA Hospital
Hines, Illinois, 60141
Franco Laghi, MD, 708-202-2705, Franco.Laghi@va.gov
Susan O'Connell, RN,MHA, 708/202-7218, Susan.Oconnell@va.gov
- Recruiting
RML Specialty Hospital
Hinsdale, Illinois, 60521
Franco Laghi, MD
Hameeda Shaikh, MD
About this study
Background: Over one million patients in the US are estimated to undergo mechanical ventilation every year, and approximately 300,000 of them fail attempts at weaning. The morbidity and mortality of these patients is greater than in patients who are successfully weaned. It follows that treatments aimed at reducing the duration of mechanical ventilation have the potential to benefit society both in terms of human suffering and cost.
Patients who fail attempts at weaning assist their inspiratory muscles during inhalation by recruiting their expiratory muscles during exhalation. Unfortunately, this recruitment occurs relatively late during a weaning trial. The knowledge that (a) expiratory muscle recruitment can assist inspiration, (b) the recruitment of the expiratory muscles is delayed during weaning, and (c) that the respiratory muscles in patients requiring mechanical ventilation are in a catabolic state raises the possibility that strategies designed to produce an early recruitment, and improve the strength, of the expiratory muscles could improve weaning outcomes in difficult to wean patients.
The current investigation, which will be conducted in healthy subjects and in ambulatory patients with chronic obstructive pulmonary disease (COPD) at Edward Hines Jr. VAH (Aims 1 and 2), and in patients who are difficult to wean from mechanical ventilation at RML Specialty Hospital, Hinsdale, IL (Aim 3), has been designed to develop and assess a novel triggering algorithm (VentFree), that controls the delivery of non-invasive neuro muscular electrical stimulation (NMES) to the abdominal-wall muscles during exhalation, and to study the physiological (respiratory) responses to such stimulation in assisting respiration in healthy subjects, in ambulatory patients with COPD and in patients requiring pronged mechanical ventilation.
- Conditions
- COPD, Weaning Failure
- Being tested
- Functional neuromuscular electrical stimulation
- Keywords
- Electric Stimulation, Respiration, Abdominal wall, Lung Diseases, Respiratory Tract Diseases, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration, Lung Diseases, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional neuromuscular electrical stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm Study | Experimental | Functional neuromuscular electrical stimulation of abdominal-wall muscles triggered by an airway pressure signal Receives: Device: Functional neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Number of breaths that are correctly stimulated during exhalation over the total number of breaths taken.
Measured: 10 minutes of resting breathing
Error rate
Number of false positive stimulation triggers over the total number of breaths taken.
Measured: 10 minutes of resting breathing
Secondary outcomes (7)
Tidal volume
Measured: 10 minutes of resting breathing
Respiratory rate
Measured: 10 minutes of resting breathing
Minute ventilation
Measured: 10 minutes of resting breathing
Esophageal pressure time product
Measured: 10 minutes of resting breathing
Trans diaphragmatic pressure time product
Measured: 10 minutes of resting breathing
Tension time index of the diaphragm
Measured: 10 minutes of resting breathing
Ratio of tidal change in Pga to tidal change in Pes
Measured: 10 minutes of resting breathing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edward Hines Jr. VA Hospital
- Sponsor type
- US federal agency
- Collaborators
- RML Specialty Hospital
- Responsible party
- Principal investigator, Franco Laghi, MD, Edward Hines Jr. VA Hospital
- Investigators
- Franco Laghi, MD, Principal investigator, Staff Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224352
- Sponsor's protocol ID
- NSF-1417104
- Status last verified
- Aug 2021
- First submitted
- 21 Aug 2014
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VentFree: A Novel Abdominal Stimulator to Assist With Ventilator Weaning
- ClinicalTrials.gov ID
- NCT02224352
- Acronym / sponsor ID
- NSF-1417104
- Conditions
- COPD, Weaning Failure
- Keywords
- Electric Stimulation, Respiration, Abdominal wall, Lung Diseases, Respiratory Tract Diseases, COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Edward Hines Jr. VA HospitalUS federal agency
- Collaborators
- RML Specialty Hospital
- Study start
- Jul 2014
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Over one million patients in the US are estimated to undergo mechanical ventilation every year, and approximately 300,000 of them fail attempts at weaning. The morbidity and mortality of these patients is greater than in patients who are successfully weaned. It follows that treatments aimed at reducing the duration of mechanical ventilation have the potential to benefit society both in terms of human suffering and cost.
Patients who fail attempts at weaning assist their inspiratory muscles during inhalation by recruiting their expiratory muscles during exhalation. Unfortunately, this recruitment occurs relatively late during a weaning trial. The knowledge that (a) expiratory muscle recruitment can assist inspiration, (b) the recruitment of the expiratory muscles is delayed during weaning, and (c) that the respiratory muscles in patients requiring mechanical ventilation are in a catabolic state raises the possibility that strategies designed to produce an early recruitment, and improve the strength, of the expiratory muscles could improve weaning outcomes in difficult to wean patients.
The current investigation, which will be conducted in healthy subjects and in ambulatory patients with chronic obstructive pulmonary disease (COPD) at Edward Hines Jr. VAH (Aims 1 and 2), and in patients who are difficult to wean from mechanical ventilation at RML Specialty Hospital, Hinsdale, IL (Aim 3), has been designed to develop and assess a novel triggering algorithm (VentFree), that controls the delivery of non-invasive neuro muscular electrical stimulation (NMES) to the abdominal-wall muscles during exhalation, and to study the physiological (respiratory) responses to such stimulation in assisting respiration in healthy subjects, in ambulatory patients with COPD and in patients requiring pronged mechanical ventilation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm Study | Experimental | Device: Functional neuromuscular electrical stimulationFunctional neuromuscular electrical stimulation of abdominal-wall muscles triggered by an airway pressure signal |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Functional neuromuscular electrical stimulation | Device | Single-Arm Study |
Primary outcome
Sensitivity
Time frame: 10 minutes of resting breathing
Number of breaths that are correctly stimulated during exhalation over the total number of breaths taken.
Error rate
Time frame: 10 minutes of resting breathing
Number of false positive stimulation triggers over the total number of breaths taken.
7 secondary outcomes
Tidal volume
Time frame: 10 minutes of resting breathing
Respiratory rate
Time frame: 10 minutes of resting breathing
Minute ventilation
Time frame: 10 minutes of resting breathing
Esophageal pressure time product
Time frame: 10 minutes of resting breathing
Trans diaphragmatic pressure time product
Time frame: 10 minutes of resting breathing
Tension time index of the diaphragm
Time frame: 10 minutes of resting breathing
Ratio of tidal change in Pga to tidal change in Pes
Time frame: 10 minutes of resting breathing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
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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.
Franco Laghi, MD principal investigator
Staff Physician
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional neuromuscular electrical stimulation in people with COPD and Weaning Failure, run by Edward Hines Jr. VA Hospital at 2 sites 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?
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: status not confirmed, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Franco Laghi, MD (708/202-2705, Franco.Laghi@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 10 minutes of resting breathing). 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 17 Aug 2021.