Diaphragm Pacing
Conditions
Brief summary
Feasibility study to advance the development of NeuRx Diaphragm Pacing System (DPS) for the intended use of stimulating the diaphragm to provide respiratory assistance in patients at risk of prolonged mechanical ventilation in the Intensive Care Unit (ICU).
Detailed description
This is a prospective, open-label, single-center study to examine the feasibility of the TransLoc DPS electrode placement and removal. Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes) and will be followed until electrode removal up to seven days post-procedure. Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures.
Interventions
DEVICETransLoc electrode
Patients will have 2 electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
Sponsors
Synapse Biomedical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is undergoing a surgical procedure with expected admission to the hospital. * Patient is undergoing a laparoscopic, open abdominal, or open chest surgical procedure that allows access to the diaphragm. * Negative pregnancy test if the patient is a female of child-bearing potential. * Patient is at least 18 years of age. * Informed consent has been obtained from the patient or designated representative.
Exclusion criteria
* Patient has an implanted cardiac defibrillator. * Patient is pregnant or breastfeeding. * The patient is involved in another clinical study that could influence the safety or outcome measures of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Experienced Complete Removal of Entire TransLoc Electrode | Postop Day 1 through hospital discharge or Day 7, whichever comes first | Number of study participants in which TransLoc electrodes were removed intact without device fragmentation or the occurrence of device or procedure related adverse events. Removal was performed by the healthcare provider by pulling electrodes from the percutaneous entry point. This was done in a similar fashion as a temporary cardiac pacing wire with a slow steady pull in a straight non oblique line. |
| Device Stimulation Using Four Electrodes Will Achieve the Predicted Tidal Volume for Study Participants | Postoperatively Day 1 | Ability of device stimulation using four electrodes to achieve or exceed the percent of predicted tidal volume for all study participant. |
| Number of Study Participants in Which Daily Diaphragm EMG Was Successfully Measured. | Postop Day 1 through hospital discharge or Day 7, whichever comes first | Ability to use the implanted electrodes to measure diaphragm EMG activity of both hemi-diaphragms for all study participants. |
| Number of Study Participants in Which TransLoc Electrodes Remained in the Diaphragm Until Removed. | Postop Day 1 through hospital discharge or 7 days, whichever comes first | Electrode stability was determined by using the electrodes to record tracings of the diaphragm EMG daily for at least a 10 minute period. The tracings were reviewed to determine diaphragm activity including characterization of diaphragm burst activity, breathing patterns and identification of apneic events, if any. The recordings also confirmed electrode stability (non-displacement and electrical integrity) during the period of temporary implantation. |
| Number of Participant That Experience Adverse Procedure and/or Device Effects | Implantation through hospital discharge or Day 7, whichever comes first. | All participants were monitored for adverse device effects (procedure and device related adverse events) from implantation of the TransLoc electrodes through electrode removal. |
| Number of Study Participants That Experience Successful Placement of Two Electrodes in Each Hemi-diaphragm | Postoperatively on Day 1 | Successful placement of two TransLoc electrodes in each hemi-diaphragm of the study participants during the operative procedure. Success was the ability to perform stimulation postoperatively using the implanted electrodes to effectively stimulate the patients for ventilation as evidenced by the ability to successfully achieve the predicted tidal volume. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Achieve a Tidal Volume of at Least 6cc/kg of Predicted Body Weight (PBW) | Postop Day 1 | Number of participants in which stimulation successfully achieves acceptable tidal volumes of at least 6cc/kg of predicted body weight (PBW). This predicted tidal volume measurement is based on the NIH NHLBI ARDS Clinical Network (ARDSnet) MV protocol criteria for Acute Respiratory Lung Syndrome (ARDS) protection resulting from the ALVELOI study. |
| Number of Participants With Successful Measurement and Characterization of Diaphragm Activity. | Postop Day 1 through hospital discharge or Day 7, whichever comes first | Characterization of diaphragm activity including characterization of diaphragm burst activity, breathing patterns and identification of apneic events, if any for each study participant. |
| Comparison of Percentage of Predicted Tidal Volumes Measured. | Postop Day 1 | Achieved percent of predicted tidal volume when stimulated using two-electrodes per hemi-diaphragm. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TransLoc Electrode Electrode placement
TransLoc electrode: Patients will have 2 electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | TransLoc Electrode | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 8 Participants | — |
| Age, Categorical Between 18 and 65 years | 4 Participants | — |
| Age, Continuous | 67.6 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 12 participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Device Stimulation Using Four Electrodes Will Achieve the Predicted Tidal Volume for Study Participants
Ability of device stimulation using four electrodes to achieve or exceed the percent of predicted tidal volume for all study participant.
Time frame: Postoperatively Day 1
Population: Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes). Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures. Four subjects in each surgical category will be studied.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Device Stimulation Using Four Electrodes Will Achieve the Predicted Tidal Volume for Study Participants | 137 Percentage of predicted tidal volume | Standard Deviation 30 |
Primary
Number of Participants That Experienced Complete Removal of Entire TransLoc Electrode
Number of study participants in which TransLoc electrodes were removed intact without device fragmentation or the occurrence of device or procedure related adverse events. Removal was performed by the healthcare provider by pulling electrodes from the percutaneous entry point. This was done in a similar fashion as a temporary cardiac pacing wire with a slow steady pull in a straight non oblique line.
Time frame: Postop Day 1 through hospital discharge or Day 7, whichever comes first
Population: Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes). Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures. Four subjects in each surgical category will be studied.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants That Experienced Complete Removal of Entire TransLoc Electrode | 12 Participants |
Primary
Number of Participant That Experience Adverse Procedure and/or Device Effects
All participants were monitored for adverse device effects (procedure and device related adverse events) from implantation of the TransLoc electrodes through electrode removal.
Time frame: Implantation through hospital discharge or Day 7, whichever comes first.
Population: Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes). Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures. Four subjects in each surgical category will be studied.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Number of Participant That Experience Adverse Procedure and/or Device Effects | 0 Events |
Primary
Number of Study Participants in Which Daily Diaphragm EMG Was Successfully Measured.
Ability to use the implanted electrodes to measure diaphragm EMG activity of both hemi-diaphragms for all study participants.
Time frame: Postop Day 1 through hospital discharge or Day 7, whichever comes first
Population: Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes). Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures. Four subjects in each surgical category will be studied.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Study Participants in Which Daily Diaphragm EMG Was Successfully Measured. | 12 Participants |
Primary
Number of Study Participants in Which TransLoc Electrodes Remained in the Diaphragm Until Removed.
Electrode stability was determined by using the electrodes to record tracings of the diaphragm EMG daily for at least a 10 minute period. The tracings were reviewed to determine diaphragm activity including characterization of diaphragm burst activity, breathing patterns and identification of apneic events, if any. The recordings also confirmed electrode stability (non-displacement and electrical integrity) during the period of temporary implantation.
Time frame: Postop Day 1 through hospital discharge or 7 days, whichever comes first
Population: Four subjects were enrolled into each of the following surgical procedural groups: laparoscopic, open abdominal and open chest.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Study Participants in Which TransLoc Electrodes Remained in the Diaphragm Until Removed. | 12 Participants |
Primary
Number of Study Participants That Experience Successful Placement of Two Electrodes in Each Hemi-diaphragm
Successful placement of two TransLoc electrodes in each hemi-diaphragm of the study participants during the operative procedure. Success was the ability to perform stimulation postoperatively using the implanted electrodes to effectively stimulate the patients for ventilation as evidenced by the ability to successfully achieve the predicted tidal volume.
Time frame: Postoperatively on Day 1
Population: Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes). Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures. Four subjects in each surgical category will be studied.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Study Participants That Experience Successful Placement of Two Electrodes in Each Hemi-diaphragm | 12 Participants |
Secondary
Comparison of Percentage of Predicted Tidal Volumes Measured.
Achieved percent of predicted tidal volume when stimulated using two-electrodes per hemi-diaphragm.
Time frame: Postop Day 1
Population: Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes). Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures. Four subjects in each surgical category will be studied.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Comparison of Percentage of Predicted Tidal Volumes Measured. | 107 percentage of predicted tidal volume | Standard Deviation 35 |
Secondary
Number of Participants That Achieve a Tidal Volume of at Least 6cc/kg of Predicted Body Weight (PBW)
Number of participants in which stimulation successfully achieves acceptable tidal volumes of at least 6cc/kg of predicted body weight (PBW). This predicted tidal volume measurement is based on the NIH NHLBI ARDS Clinical Network (ARDSnet) MV protocol criteria for Acute Respiratory Lung Syndrome (ARDS) protection resulting from the ALVELOI study.
Time frame: Postop Day 1
Population: Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes). Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures. Four subjects in each surgical category will be studied.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants That Achieve a Tidal Volume of at Least 6cc/kg of Predicted Body Weight (PBW) | 12 Participants |
Secondary
Number of Participants With Successful Measurement and Characterization of Diaphragm Activity.
Characterization of diaphragm activity including characterization of diaphragm burst activity, breathing patterns and identification of apneic events, if any for each study participant.
Time frame: Postop Day 1 through hospital discharge or Day 7, whichever comes first
Population: Twelve (12) subjects undergoing a surgical procedure will receive the device (four electrodes). Subjects will be selected from surgical candidates undergoing laparoscopic, open abdominal, and open thoracic procedures. Four subjects in each surgical category will be studied.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Participants With Successful Measurement and Characterization of Diaphragm Activity. | 12 Participants |