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

NCT03019107 | Terminated Results

• 1 other identifier: LM-KINDRED-01
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Electric Stimulation; Respiration, Artificial; Ventilator Weaning

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (13)

• Change in Thickness of the Transverse Abdominis Muscle From Baseline to Extubation

  Change from baseline to first extubation, an expected average of 4 weeks

• Change in Thickness of the External Oblique Muscle From Baseline to Extubation

  Change from baseline to first extubation, an expected average of 4 weeks

• 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 Rectus Abdominis Muscle

  Change from baseline to first extubation, an expected average of 4 weeks

• Thickness of the Diaphragm

  Change from baseline to first extubation, an expected average of 4 weeks

Study Arms (2)

VentFree Stimulation

EXPERIMENTAL

Breath synchronized abdominal NMES

Device: Breath synchronized abdominal NMES

Sham Stimulation

SHAM COMPARATOR

Sham breath synchronized abdominal NMES

Device: Sham breath synchronized abdominal NMES

Interventions

Breath synchronized abdominal NMES DEVICE

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.

Also known as: VentFree

VentFree Stimulation

Sham breath synchronized abdominal NMES DEVICE

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.

Sham Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Liberate Medical: lead

Study Sites (1)

Kindred Hospital

Louisville, Kentucky, 40204, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Angus Mclachlan
• Organization: Liberate Medical

info@liberatemedical.com

+1 (833) 203-4663

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: January 12, 2017
• Study Start: February 22, 2017
• Primary Completion: April 6, 2017
• Study Completion: April 6, 2017
• Last Updated: November 8, 2021
• Results First Posted: November 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)