VentFree: A Novel Abdominal Stimulator to Assist With Ventilator Weaning

NCT ID: NCT02224352

Last Updated: 2021-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2022-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Single-Arm Study

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

Group Type: EXPERIMENTAL

Functional neuromuscular electrical stimulation

Intervention Type: DEVICE

Interventions

Functional neuromuscular electrical stimulation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RML Specialty Hospital

OTHER

Sponsor Role: collaborator

Edward Hines Jr. VA Hospital

FED

Sponsor Role: lead

Responsible Party

Franco Laghi, MD

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Franco Laghi, MD

Role: PRINCIPAL_INVESTIGATOR

Staff Physician

Locations

Edward G. Hines Jr., VA Hospital

Hines, Illinois, United States

Site Status: RECRUITING

RML Specialty Hospital

Hinsdale, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Franco Laghi, MD

Role: CONTACT

Franco.Laghi@va.gov

708/202-2705

Hameeda Shaikh, MD

Role: CONTACT

Hameeda.Shaikh@va.gov

708/202-2705

Facility Contacts

Franco Laghi, MD

Role: primary

Franco.Laghi@va.gov

708-202-2705

Susan O'Connell, RN,MHA

Role: backup

Susan.Oconnell@va.gov

708/202-7218

Other Identifiers

NSF-1417104

Identifier Type: -

Identifier Source: org_study_id