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

Terminated

Conditions: Respiration, Artificial
Ventilator Weaning
Electric Stimulation

Interventions: Device: Sham breath synchronized abdominal NMES
Device: Breath synchronized abdominal NMES

Registration Number: NCT03019107

Lead Sponsor: Liberate Medical

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 2

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Stimulation	Sham breath synchronized abdominal NMES	Sham breath synchronized abdominal NMES
VentFree Stimulation	Breath synchronized abdominal NMES	Breath synchronized abdominal NMES

Primary Outcome Measures

Name	Time	Method
Change in Maximum Inspiratory Pressure From Baseline to Extubation	Change from baseline to first extubation, an expected average of 4 weeks	Maximum inspiratory pressure was measured from end expiratory lung volume.
Change in Maximum Expiratory Pressure From Baseline to Extubation	Change from baseline to first extubation, an expected average of 4 weeks	Maximum expiratory pressure was measured from total lung capacity

Secondary Outcome Measures

Name	Time	Method
Thickness of the Rectus Abdominis Muscle	Change from baseline to first extubation, an expected average of 4 weeks	Thickness of the rectus abdominis muscle as measured by ultrasound
Number of Days Taken to Wean	The earlier of 6 weeks or first extubation, an expected average of 4 weeks
Thickness of the Diaphragm	Change from baseline to first extubation, an expected average of 4 weeks	Thickness of the diaphragm as measured by ultrasound
Weaning Success	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
Change in Cough Peak Flow From Baseline to Extubation	Change from baseline to first extubation, an expected average of 4 weeks	Cough peak flow was measured from total lung capacity
Change in Spontaneous Respiratory Rate From Baseline to Final Study Visit	Change from baseline to final study visit, an expected average of 4 weeks
Change in Thickness of the Transverse Abdominis Muscle From Baseline to Extubation	Change from baseline to first extubation, an expected average of 4 weeks	Thickness of transverse abdominis muscle as measured by ultrasound
Change in Thickness of the External Oblique Muscle From Baseline to Extubation	Change from baseline to first extubation, an expected average of 4 weeks	Thickness of the external oblique muscle as measured by ultrasound
Change in Thickness of the Internal Oblique Muscle From Baseline to Extubation	Change from baseline to first extubation, an expected average of 4 weeks	Thickness of the internal oblique muscle as measured by ultrasound
Change in Spontaneous Tidal Volume From Baseline to Final Visit or First Extubation	Change from baseline to final study visit or first extubation, an expected average of 4 weeks
Change in Spontaneous Minute Ventilation From Baseline to Final Study Visit	Change from baseline to final study visit, an expected average of 4 weeks
Number of Adverse Events That Are Related to Treatment	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.
Maximum Sensation of Stimulation Experienced by Patient	Through study completion, an expected average of 4 weeks	Measured using the behavioral pain scale