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

October 11, 2021 updated by: Liberate Medical

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40204
        • Kindred Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VentFree Stimulation
Breath synchronized abdominal NMES
Device: 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.
Other Names:
  • VentFree
Sham Comparator: Sham Stimulation
Sham breath synchronized abdominal NMES
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 from baseline to first extubation, an expected average of 4 weeks
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.
Change from baseline to first extubation, an expected average of 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Change from baseline to first extubation, an expected average of 4 weeks
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
Time Frame: Change from baseline to first extubation, an expected average of 4 weeks
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
Time Frame: Change from baseline to first extubation, an expected average of 4 weeks
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
Time Frame: Change from baseline to first extubation, an expected average of 4 weeks
Thickness of the diaphragm as measured by ultrasound
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
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
Time Frame: The earlier of 6 weeks or first extubation, an expected average of 4 weeks
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
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
Time Frame: Change from baseline to final study visit or first extubation, an expected average of 4 weeks
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 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
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
Measured using the behavioral pain scale
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Liberate Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 6, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 6, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LM-KINDRED-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiration, Artificial

Clinical Trials on Breath synchronized abdominal NMES

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings