Back to resultsSpinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients
Primary Purpose
Respiratory Distress Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous Biopac Electrical Stimulator
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Distress Syndrome focused on measuring Respiratory Distress Syndrome
Eligibility Criteria
Inclusion Criteria: Male or female 18-85 years; Intubated with confirmed diagnosis of ARDS (by Berlin Criteria: acute onset within one week of known insult, bilateral airspace opacities not fully explained by pleural effusions, atelectasis, and/or nodules, respiratory failure not explained by heart failure or fluid overload, PaO2/FiO2 ratio < 300); or identified as a patient admitted to the intensive care unit (ICU) after non-cardiac surgery; Able to provide informed consent or available next of kin able to provide informed consent; Have intact chest/lung, upper and lower extremity anatomy; The neuromuscular connections between the spinal cord, diaphragm, and intercostal muscles are intact; Enrollment of subject within 48 hours of intubation; Able to induce evoked response of diaphragm muscle by spinal cord TES. Exclusion Criteria: Phrenic nerve or diaphragm pacer; History of seizure disorder or on anti-epileptic medication for the treatment of seizures; Compromised skin in back (neck, upper and lower back); Pregnancy; Implanted devices: cardiac pacemakers, implanted defibrillators, implanted neurostimulators, phrenic nerve pacers; BMI greater than or equal to 35; Pharmacological paralysis/neuromuscular blockade*.
Sites / Locations
- University of California, Los AngelesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ARDS cohort
Surgery Cohort (Active)
Arm Description
Patient diagnosed with ARDS. Treated daily for 60 minutes with transcutaneous cervical and/or thoracic spinal stimulation
Patient undergoing inpatient non-cardiac surgery admitted to the intensive care unit (ICU) after surgery. Treated daily for 60 minutes with transcutaneous cervical and/or thoracic spinal stimulation
Outcomes
Primary Outcome Measures
Recording of significant stimulation-induced adverse events (AE)
Although unlikely, we will record and monitor the number of stimulation-induced adverse events per case and per cohort. Our goal is to have an overall AE rate of less than 10% per cohort.
Secondary Outcome Measures
Recording of total ventilation time
The total time that patient is ventilated will be recorded to determine if stimulation reduces total intubation time
Measurement of diaphragm thickness
Evidence of maintenance of diaphragm muscle thickness (in mm) by ultrasound
Assessment of diaphragm and respiratory muscle EMG amplitudes
EMG amplitudes of diaphragm and other muscles involved in respiration (intercostals, trapezius, abdominal) will be measured at a couple time points throughout the study period to determine if stimulation can maintain muscle response.
Measurement of respiratory pressure
Peak Inspiratory and Expiratory pressure measurements (in mm Hg) will be recorded from ventilation units to determine if stimulation maintains or improves respiratory airway pressure.
Assessment of respiratory tidal volume
Respiratory Tidal Volume (voluntary and resting) will be recorded (in mL) to determine if stimulation assists in maintaining or improving lung capacity.
Measurement of ventilator weaning time
Measurements of ventilator weaning time will be recorded to determine if stimulation assists in decreasing the total time from complete intubation to complete extubation.
Full Information
NCT ID
NCT05928052
First Posted
May 23, 2023
Last Updated
June 22, 2023
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT05928052
Brief Title
Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients
Official Title
Transcutaneous Spinal Cord Stimulation to Improve Respiratory Function and Shorten Ventilator Dependence in Patients With ARDS
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2022 (Actual)
Primary Completion Date
January 6, 2027 (Anticipated)
Study Completion Date
January 6, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is an early phase, proof-of-concept clinical trial assessing the safety and feasibility of non-invasive spinal cord stimulation to prevent respiratory muscle atrophy in mechanically ventilated ARDS patients. The investigators will recruit 10 elective surgery patients (surgery cohort) and 10 ARDS patients (ARDS cohort) for this study. A non-invasive, alpha-prototype Restore Technology stimulator using hydrogel surface electrodes will be used to stimulate the spinal cord at the cervical or thoracic level.
Detailed Description
Stimulation will be conducted in closed-loop fashion at the start of inspiratory cycle. Signal from a chest belt will be used to synchronize stimulation with ventilator and prevent interference with ventilator (see Protection of Human Subjects). Prior to treatment stimulation, mapping will be conducted at 1 Hz with electrodes placed in locations identified to be optimal in the surgery cohort. Assessment of evoked EMG responses from respiratory muscles will be conducted. Once this electrode configuration is confirmed as effective (capable of evoking EMG activity), stimulation with this configuration will be applied for treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
Keywords
Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ARDS cohort
Arm Type
Experimental
Arm Description
Patient diagnosed with ARDS. Treated daily for 60 minutes with transcutaneous cervical and/or thoracic spinal stimulation
Arm Title
Surgery Cohort (Active)
Arm Type
Experimental
Arm Description
Patient undergoing inpatient non-cardiac surgery admitted to the intensive care unit (ICU) after surgery. Treated daily for 60 minutes with transcutaneous cervical and/or thoracic spinal stimulation
Intervention Type
Device
Intervention Name(s)
Transcutaneous Biopac Electrical Stimulator
Intervention Description
A transcutaneous electrical stimulator sends low levels of electrical current through surface hydrogel electrodes directly to the spinal cord to improve function.
Primary Outcome Measure Information:
Title
Recording of significant stimulation-induced adverse events (AE)
Description
Although unlikely, we will record and monitor the number of stimulation-induced adverse events per case and per cohort. Our goal is to have an overall AE rate of less than 10% per cohort.
Time Frame
1-48 months
Secondary Outcome Measure Information:
Title
Recording of total ventilation time
Description
The total time that patient is ventilated will be recorded to determine if stimulation reduces total intubation time
Time Frame
1-48 months
Title
Measurement of diaphragm thickness
Description
Evidence of maintenance of diaphragm muscle thickness (in mm) by ultrasound
Time Frame
1-48 months
Title
Assessment of diaphragm and respiratory muscle EMG amplitudes
Description
EMG amplitudes of diaphragm and other muscles involved in respiration (intercostals, trapezius, abdominal) will be measured at a couple time points throughout the study period to determine if stimulation can maintain muscle response.
Time Frame
1-48 months
Title
Measurement of respiratory pressure
Description
Peak Inspiratory and Expiratory pressure measurements (in mm Hg) will be recorded from ventilation units to determine if stimulation maintains or improves respiratory airway pressure.
Time Frame
1-48 months
Title
Assessment of respiratory tidal volume
Description
Respiratory Tidal Volume (voluntary and resting) will be recorded (in mL) to determine if stimulation assists in maintaining or improving lung capacity.
Time Frame
1-48 months
Title
Measurement of ventilator weaning time
Description
Measurements of ventilator weaning time will be recorded to determine if stimulation assists in decreasing the total time from complete intubation to complete extubation.
Time Frame
1-48 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female 18-85 years;
Intubated with confirmed diagnosis of ARDS (by Berlin Criteria: acute onset within one week of known insult, bilateral airspace opacities not fully explained by pleural effusions, atelectasis, and/or nodules, respiratory failure not explained by heart failure or fluid overload, PaO2/FiO2 ratio < 300); or identified as a patient admitted to the intensive care unit (ICU) after non-cardiac surgery;
Able to provide informed consent or available next of kin able to provide informed consent;
Have intact chest/lung, upper and lower extremity anatomy;
The neuromuscular connections between the spinal cord, diaphragm, and intercostal muscles are intact;
Enrollment of subject within 48 hours of intubation;
Able to induce evoked response of diaphragm muscle by spinal cord TES.
Exclusion Criteria:
Phrenic nerve or diaphragm pacer;
History of seizure disorder or on anti-epileptic medication for the treatment of seizures;
Compromised skin in back (neck, upper and lower back);
Pregnancy;
Implanted devices: cardiac pacemakers, implanted defibrillators, implanted neurostimulators, phrenic nerve pacers;
BMI greater than or equal to 35;
Pharmacological paralysis/neuromuscular blockade*.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Lu, MD, PhD
Phone
310-825-4321
Email
dclu@mednet.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
James C Leiter, MD
Phone
603-650-6130
Email
jleiter@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Lu, MD, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel C Lu, MD, PhD
Phone
310-267-2975
Email
dclu@mednet.ucla.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.uclahealth.org/clinical-trials
Description
UCLA Clinical Trials
Learn more about this trial
Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients
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