VentFree: A Novel Abdominal Stimulator to Assist With Ventilator Weaning

NCT02224352 | Unknown FDA Device

• 1 other identifier: NSF-1417104
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief 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. 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

Keywords

Electric Stimulation; Respiration; Abdominal wall; Lung Diseases; Respiratory Tract Diseases; COPD

Outcome Measures

Primary Outcomes (2)

• Sensitivity

  Number of breaths that are correctly stimulated during exhalation over the total number of breaths taken.

  10 minutes of resting breathing

• Error rate

  Number of false positive stimulation triggers over the total number of breaths taken.

  10 minutes of resting breathing

Secondary Outcomes (7)

• Tidal volume

  10 minutes of resting breathing

• Respiratory rate

  10 minutes of resting breathing

• Minute ventilation

  10 minutes of resting breathing

• Esophageal pressure time product

  10 minutes of resting breathing

• Trans diaphragmatic pressure time product

  10 minutes of resting breathing

Study Arms (1)

Single-Arm Study

EXPERIMENTAL

Functional neuromuscular electrical stimulation of abdominal-wall muscles triggered by an airway pressure signal

Device: Functional neuromuscular electrical stimulation

Interventions

Functional neuromuscular electrical stimulation DEVICE

Single-Arm Study

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• No history of acute or chronic respiratory disease, cardiac or neuromuscular disease.
• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edward Hines Jr. VA Hospital: lead
• RML Specialty Hospital: collaborator

Study Sites (2)

Edward G. Hines Jr., VA Hospital

Hines, Illinois, 60141, United States

RECRUITING

RML Specialty Hospital

Hinsdale, Illinois, 60521, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration; Lung Diseases; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Study Officials

• Franco Laghi, MD

  Staff Physician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Franco Laghi, MD

CONTACT

708/202-2705; Franco.Laghi@va.gov

Hameeda Shaikh, MD

CONTACT

708/202-2705; Hameeda.Shaikh@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 25, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: August 17, 2021

Record last verified: 2021-08

Locations

US (2)