VentFree: A Novel Abdominal Stimulator to Assist With Ventilator Weaning

Not Applicable

• Conditions: COPD; Weaning Failure
• Interventions: Device: Functional neuromuscular electrical stimulation

• Registration Number: NCT02224352
• Lead Sponsor: Edward Hines Jr. VA Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-21
• Study First Submitted QC: 2014-08-21
• Study First Posted: 2014-08-25
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-17
• Primary Completion: 2022-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-Arm Study	Functional neuromuscular electrical stimulation	Functional neuromuscular electrical stimulation of abdominal-wall muscles triggered by an airway pressure signal

Primary Outcome Measures

Name	Time	Method
Sensitivity	10 minutes of resting breathing	Number of breaths that are correctly stimulated during exhalation over the total number of breaths taken.
Error rate	10 minutes of resting breathing	Number of false positive stimulation triggers over the total number of breaths taken.

Secondary Outcome Measures

Name	Time	Method
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
Tension time index of the diaphragm	10 minutes of resting breathing
Ratio of tidal change in Pga to tidal change in Pes	10 minutes of resting breathing
Trans diaphragmatic pressure time product	10 minutes of resting breathing

Trial Locations

Locations (2)

Edward G. Hines Jr., VA Hospital; 🇺🇸 Hines, Illinois, United States

RML Specialty Hospital; 🇺🇸 Hinsdale, Illinois, United States