Clinical trial NCT03019107: Breath Synchronized Abdominal Muscle Stimulation to Facilitate Ventilator Weaning: a Pilot Study
Official title: Breath Synchronized Abdominal Muscle Stimulation to Facilitate Ventilator Weaning: a Pilot
Study type: INTERVENTIONAL
Overall status: TERMINATED
Conditions: Electric Stimulation
Respiration, Artificial
Ventilator Weaning
Lead sponsor: Liberate Medical
Sponsor class: INDUSTRY
First posted: 2017-01-12
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Maximum Expiratory Pressure From Baseline to Extubation
timeFrame: Change from baseline to first extubation, an expected average of 4 weeks
measure: Change in Maximum Inspiratory Pressure From Baseline to Extubation
timeFrame: Change from baseline to first extubation, an expected average of 4 weeks
Secondary outcomes:
measure: Change in Thickness of the Transverse Abdominis Muscle From Baseline to Extubation
timeFrame: Change from baseline to first extubation, an expected average of 4 weeks
measure: Change in Thickness of the External Oblique Muscle From Baseline to Extubation
timeFrame: Change from baseline to first extubation, an expected average of 4 weeks
measure: Change in Thickness of the Internal Oblique Muscle From Baseline to Extubation
timeFrame: Change from baseline to first extubation, an expected average of 4 weeks
measure: Thickness of the Rectus Abdominis Muscle
timeFrame: Change from baseline to first extubation, an expected average of 4 weeks
measure: Thickness of the Diaphragm
timeFrame: Change from baseline to first extubation, an expected average of 4 weeks
measure: Weaning Success
timeFrame: The earlier of 6 weeks or first extubation, an expected average of 4 weeks
measure: Number of Days Taken to Wean
timeFrame: The earlier of 6 weeks or first extubation, an expected average of 4 weeks
measure: Change in Cough Peak Flow From Baseline to Extubation
timeFrame: Change from baseline to first extubation, an expected average of 4 weeks
measure: Change in Spontaneous Tidal Volume From Baseline to Final Visit or First Extubation
timeFrame: Change from baseline to final study visit or first extubation, an expected average of 4 weeks
measure: Change in Spontaneous Respiratory Rate From Baseline to Final Study Visit
timeFrame: Change from baseline to final study visit, an expected average of 4 weeks
measure: Change in Spontaneous Minute Ventilation From Baseline to Final Study Visit
timeFrame: Change from baseline to final study visit, an expected average of 4 weeks
measure: Maximum Sensation of Stimulation Experienced by Patient
timeFrame: Through study completion, an expected average of 4 weeks
measure: Number of Adverse Events That Are Related to Treatment
timeFrame: Though study completion, an expected average of 4 weeks
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kindred Hospital
state: Kentucky
Study officials:
References: