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

Respiration, Artificial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03019107
• Other study ID #: LM-KINDRED-01
• Status: Terminated
• Start date: February 22, 2017
• Est. completion date: April 6, 2017

Study information

• Verified date: October 2021
• Source: Liberate Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 6, 2017
• Est. primary completion date: April 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Electric Stimulation
• Respiration, Artificial
• Ventilator Weaning

Intervention

Device:
• Breath synchronized abdominal NMES
VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.
• Sham breath synchronized abdominal NMES
Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.

Locations

Country	Name	City	State
United States	Kindred Hospital	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Liberate Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Maximum Expiratory Pressure From Baseline to Extubation	Maximum expiratory pressure was measured from total lung capacity	Change from baseline to first extubation, an expected average of 4 weeks
Primary	Change in Maximum Inspiratory Pressure From Baseline to Extubation	Maximum inspiratory pressure was measured from end expiratory lung volume.	Change from baseline to first extubation, an expected average of 4 weeks
Secondary	Change in Thickness of the Transverse Abdominis Muscle From Baseline to Extubation	Thickness of transverse abdominis muscle as measured by ultrasound	Change from baseline to first extubation, an expected average of 4 weeks
Secondary	Change in Thickness of the External Oblique Muscle From Baseline to Extubation	Thickness of the external oblique muscle as measured by ultrasound	Change from baseline to first extubation, an expected average of 4 weeks
Secondary	Change in Thickness of the Internal Oblique Muscle From Baseline to Extubation	Thickness of the internal oblique muscle as measured by ultrasound	Change from baseline to first extubation, an expected average of 4 weeks
Secondary	Thickness of the Rectus Abdominis Muscle	Thickness of the rectus abdominis muscle as measured by ultrasound	Change from baseline to first extubation, an expected average of 4 weeks
Secondary	Thickness of the Diaphragm	Thickness of the diaphragm as measured by ultrasound	Change from baseline to first extubation, an expected average of 4 weeks
Secondary	Weaning Success	Defined as free from ventilator support for more than 72 hours	The earlier of 6 weeks or first extubation, an expected average of 4 weeks
Secondary	Number of Days Taken to Wean		The earlier of 6 weeks or first extubation, an expected average of 4 weeks
Secondary	Change in Cough Peak Flow From Baseline to Extubation	Cough peak flow was measured from total lung capacity	Change from baseline to first extubation, an expected average of 4 weeks
Secondary	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
Secondary	Change in Spontaneous Respiratory Rate From Baseline to Final Study Visit		Change from baseline to final study visit, an expected average of 4 weeks
Secondary	Change in Spontaneous Minute Ventilation From Baseline to Final Study Visit		Change from baseline to final study visit, an expected average of 4 weeks
Secondary	Maximum Sensation of Stimulation Experienced by Patient	Measured using the behavioral pain scale	Through study completion, an expected average of 4 weeks
Secondary	Number of Adverse Events That Are Related to Treatment	This includes any adverse event that was graded as having a possible, probable or definite relationship to the study intervention.	Though study completion, an expected average of 4 weeks