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

Liberate Medical

Status

Terminated

Conditions

Ventilator Weaning

Respiration, Artificial

Electric Stimulation

Treatments

Device: Sham breath synchronized abdominal NMES

Device: Breath synchronized abdominal NMES

Study type

Interventional

Funder types

Industry

Identifiers

NCT03019107

LM-KINDRED-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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