Initial Assessment of the Percutaneous Electrical Phrenic Nerve Stimulation System in Patients on Mechanical Ventilation

James O'Rourke, Michal Soták, Gerard F Curley, Aoife Doolan, Tomáš Henlín, Gerard Mullins, Tomáš Tyll, William Omlie, Marco V Ranieri, James O'Rourke, Michal Soták, Gerard F Curley, Aoife Doolan, Tomáš Henlín, Gerard Mullins, Tomáš Tyll, William Omlie, Marco V Ranieri

Abstract

Objectives: Maintaining diaphragm work using electrical stimulation during mechanical ventilation has been proposed to attenuate ventilator-induced diaphragm dysfunction. This study assessed the safety and feasibility of temporary percutaneous electrical phrenic nerve stimulation on user-specified inspiratory breaths while on mechanical ventilation.

Design: Two-center, nonblinded, nonrandomized study.

Setting: Hospital ICU.

Patients: Twelve patients mechanically ventilated from 48 hours to an expected 7 days.

Interventions: Leads were inserted to lie close to the phrenic nerve in the neck region using ultrasound guidance. Two initial patients had left-sided placement only with remaining patients undergoing bilateral lead placement. Percutaneous electrical phrenic nerve stimulation was used for six 2-hour sessions at 8-hour intervals over 48 hours.

Measurements and main results: Data collected included lead deployment success, nerve conduction, ventilation variables, work of breathing, electrical stimulation variables, stimulation breath synchrony, and diaphragm thickness measured by ultrasound at baseline, 24, and 48 hours. Primary endpoints included ability to capture the left and/or right phrenic nerves and maintenance of work of breathing within defined limits for 80% of stimulated breaths. Lead insertion was successful in 21 of 22 attempts (95.5%). Analysis of 36,059 stimulated breaths from 10 patients with attempted bilateral lead placement demonstrated a mean inspiratory lag for phrenic nerve stimulation of 23.7 ms (p < 0.001 vs null hypothesis of <88ms). Work of breathing was maintained between 0.2 and 2.0 joules/L 96.8% of the time, exceeding the 80% target. Mean diaphragm thickness increased from baseline by 7.8% at 24 hours (p = 0.022) and 15.0% at 48 hours (p = 0.0001) for patients receiving bilateral stimulation after excluding one patient with pleural effusion. No serious device/procedure-related adverse events were reported.

Conclusions: The present study demonstrated the ability to safely and successfully place percutaneous electrical phrenic nerve stimulation leads in patients on mechanical ventilation and the feasibility of using this approach to synchronize electrical stimulation with inspiration while maintaining work of breathing within defined limits.

Conflict of interest statement

Drs. O’Rourke, Soták, Doolan, Henlín, Mullins, and Tyll’s institutions received funding from Stimdia Medical. Drs. O’Rourke, Doolan, and Ranieri disclosed off-label product use of pdSTIM 4300 Leads and Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Console. Dr. Ranieri disclosed work for hire. Drs. Omlie and Ranieri were members of the PEPNS Study Clinical Events Committee.

Figures

Figure 1.
Figure 1.
Percutaneous electrical phrenic nerve stimulation (PEPNS) system setup. A, Illustration showing PEPNS console setup connected to two L4300 pdSTIM leads in patients’ neck and a wye flow sensor. PEPNS console analog outputs connected to data acquisition system. Electrical stimulation through the L4300 leads is delivered at a user-specified inspiratory count. B, Diagram showing pdSTIM L4300 lead positioned between sternocleidomastoid muscle (SCM) and anterior scalene muscle (ASM) muscles in the patient’s neck such that the lead passes over the phrenic nerve. ETT = endotracheal tube, WOB = work of breathing.
Figure 2.
Figure 2.
Data graphical display. Data collected from P0702 Stim Session no 3. A, Qwye in red (flow at the patient wye, in liters per minute); Trigger Flow in grey (User specified inspiratory trigger, in liters per minute [Lpm]). B, Pwye in green (measured pressure at the patient wye, in centimeters of water [cm H2O]); PwyePred in blue (predicted wye pressure based upon the equation of motion, in cm H2O); Pmus in red (diaphragm pressure as a result of the electrical stimulation and/or patient effort, in cm H2O); Stim On in yellow (diaphragmatic stimulation active, where –12 = on and 0 = off); inspiratory expiratory (IE) signal in orange (where –10 = inspiration and 0 = exhalation). C, Work of breathing (WOB) in black, updated at the end of each inspiration cycle for both stimulated and unstimulated breath in joules per liter (J/L).

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