Pharyngeal Electrical Stimulation Treatment of Critically Ill Intensive Care Tracheostomized Patients Presenting with Severe Neurogenic Dysphagia: A Case Series

Case Series

Austin J Pulm Respir Med. 2022; 9(1): 1088.

Pharyngeal Electrical Stimulation Treatment of Critically Ill Intensive Care Tracheostomized Patients Presenting with Severe Neurogenic Dysphagia: A Case Series

Traugott MT*, Hoepler W, Kelani H, Schatzl M, Friese E and Neuhold S

¹Department with Infectious Diseases and Tropical Medicine, Klinik Favoriten, Austria

*Corresponding author: Marianna Theresia Traugott, Fourth Medical Department with Infectious Diseases and Tropical Medicine, Klinik Favoriten, KundratstraΒe 3, 1100 Vienna, Austria

Received: June 16, 2022; Accepted: July 20, 2022; Published: July 26, 2022

Abstract

Purpose: To assess the benefits of Pharyngeal Electrical Stimulation (PES) in critically ill tracheostomized patients with severe neurogenic dysphagia.

Methods: A retrospective outcome analysis of tracheostomized patients weaned from mechanical ventilation and treated with PES in a medical ICU.

Results: Nineteen patients (mean age: 64 years), admitted to the ICU mainly because of severe acute infections, were treated with PES whilst still tracheostomized (mean duration of intubation prior to tracheostomy: 12 days). Following the start of PES, 15/19 patients were successfully decannulated during their hospital stay (mean time to decannulation: 13 days); 11 of the 15 surviving patients experienced a complete restoration of swallowing function. Among patients with available data, the mean time to improved feeding status from “nil by mouth” was three days with thickened fluids and ten days with thin oral fluid. The mean length of stay was eleven days in the ICU and 56 days in the hospital. PES treated tracheostomized patients had a shorter mean LOS in the ICU (47 vs 58 days) and in the hospital (109 vs 125 days) compared to non- PES treated ones. No serious adverse events related to PES treatment were observed, and no patients required recannulation.

Conclusions: In this mixed population, PES led to improved swallowing function resulting in successful decannulation of 15/19 patients and return to normal oral intake at hospital discharge in 11/15 patients with severe neurogenic swallowing disorders and tracheostomy.

Keywords: Neurogenic dysphagia; Swallowing disorders; Intensive and critical care; Pharyngeal electrical stimulation; Tracheostomy; Prolonged mechanical ventilation

Introduction

Swallowing disorders (dysphagia) are associated with an increased risk of delayed decannulation and prolonged Intensive Care Unit (ICU) stay. Outside the ICU-setting, dysphagia can lead to dehydration, malnutrition, and death [1]. The use of analgesic and sedative drugs may also contribute to dysphagia [1]. Critically ill ICU patients often require endotracheal intubation and sometimes tracheostomy after prolonged mechanical ventilation. Following tracheostomy, a dysphagia incidence of 11 to 93% has been reported [2]. Patients with persistent and severe dysphagia fail to be decannulated until hospital discharge, which can contribute to mortality [3]. Nevertheless, in most ICUs, dysphagia screening is not systematically performed [4]. One of the largest studies to date implementing systematic dysphagia screening in the ICU (DYnAMICS), identified post-extubation swallowing disorders at ICU discharge in 10% of cases, and in 60% of dysphagia cases, swallowing disorders persisted until hospital discharge [5]. Behavioral swallowing interventions, which include compensatory strategies, rehabilitative exercises, and manoeuvers, generally have limited scientific evidence and appear to be only moderately effective in patients presenting with severe neurogenic dysphagia [6]; in addition, these interventions require active patient participation. In critically ill ICU patients, active engagement is frequently not possible.

Pharyngeal Electrical Stimulation (PES) is a novel and innovative treatment for restoring neurological control of swallowing [7]. It was first validated in non-ventilated stroke patients with dysphagia [8,9] and later in tracheostomized stroke patients with severe dysphagia [10-12]. A meta-analysis including three RCTs concluded that PES treatment was associated with less aspiration and less dysphagia in patients with poststroke dysphagia [13]. Muhle et al. reported on 23 tracheostomized stroke patients who could not be decannulated due to severe and persisting dysphagia; after PES treatment, decannulation was successful in 79% of patients [11]. In the prospective, single-blinded, randomized PHAST-TRAC trial, PES enabled earlier decannulation of tracheostomized patients presenting with severe neurogenic dysphagia after stroke [10]. In the prospective single-arm observational cohort PHADER study, 245 patients with neurogenic dysphagia following stroke or traumatic brain injury, with and without mechanical ventilation and tracheostomy, as well as non-stroke ventilated patients, were treated with PES showing a significant improvement in airway safety and diet advancement [14]. Moreover, PES has been shown to be effective and safe in the treatment of dysphagia associated with several other pathologies: Guillain-Barré syndrome [15], multiple sclerosis [16], COVID-19 infection [17,18] and critical illness polyneuropathy [19].

In this retrospective outcome analysis study, we aimed to determine the benefits of PES treatment in critically ill, tracheostomized patients from an internal medicine ICU with severe swallowing impairment following prolonged mechanical ventilation.

Methods

Patients

This case series describes 19 critically ill ICU patients with severe neurogenic dysphagia following prolonged mechanical ventilation who were treated with PES while tracheostomized in a public hospital in Vienna (Austria) between October 2017 and January 2020. A retrospective analysis of the patients’ health data was performed to gain improved understanding of PES treatment outcomes. Disease severity at ICU admission was categorized using the APACHE II disease severity score [20,21]. Patients underwent dysphagia screening by nursing staff and clinical swallowing evaluations by a Speech and Language Therapist (SLT) in the ICU. Patients were followed-up until hospital discharge for critical outcomes related to dysphagia (tracheostomy decannulation, swallowing and feeding status) and general outcome parameters (Length Of Stay (LOS) in ICU and hospital, discharge destination, and mortality). Data on the occurrence of device deficiencies and serious adverse events related to PES-treatment or the device were also collected. Feeding status was evaluated using functional swallowing outcome measures including the Dysphagia Severity Rating Scale (DSRS, 12 being the worst score) [22] and Functional Oral Intake Scale (FOIS, 1 being the worst score) [23].

PES Treatment

PES treatments were applied using the commercially available Phagenyx® system (Phagenesis Ltd, Manchester, UK). This medical device received CE certification in 2012 and consists of a base station and a specially designed, single-patient use nasogastric catheter with built-in electrodes. The electrodes of the PES-catheter are positioned in a specific location within the pharynx and used to deliver trains (200 μs pulses at 5 Hz) of pharyngeal electrical simulation for ten minutes per day for three consecutive days (=one cycle) and repeated in a second cycle of three consecutive treatment days if required. The current intensity (mA) of PES is optimized to the patient based upon their individualized sensory capacity prior to every treatment session, as reported previously [10,19] The Phagenyx® catheter can also be used as a nasogastric tube for enteral feeding.

Data collection and Statistical Analysis

The following data were extracted from available medical records, anonymized, and analyzed: i) patients’ demographics and clinical characteristics (age, gender, disease severity, diagnoses, comorbidities, cause of death) at ICU admission; ii) duration of intubation, sedation, and time from intubation until tracheostomy; iii) dysphagia assessments; iv) PES treatment parameters (threshold, tolerance, and stimulation intensities in mA); and v) PES treatment outcomes (decannulation status, as well as swallowing and feeding status).

Ethical Considerations

This retrospective case series analysis was conducted in accordance with the principles of Good Clinical Practice and following the Declaration of Helsinki. Study participants’ privacy and confidentiality was guaranteed according to Austrian law (Austrian Data Protection Act, version: 25 May 2018; BGBl. I Nr. 165/1999).

Statistical Analysis

All anonymized data were centrally collected and analyzed at our medical department using descriptive statistics. Descriptive and categorical data are expressed as frequencies and proportions, while continuous data are reported as mean and range.

Results

Description of Cases

A total of 19 critically ill, internal medicine patients admitted to ICU were treated with PES for severe neurogenic dysphagia following prolonged endotracheal intubation and subsequent tracheostomy between October 2017 and January 2020. Baseline patient characteristics are described in (Table 1). Overall, patients were predominantly male (68%), with a mean age of 64 years (range: 44-81), 63% being 61 years old or older. At ICU admission, the mean disease severity score (APACHE II) was 20 (range: 4-29), with ten out of 19 patients (53%) presenting with a high mortality probability (APACHE II score: 20-29). Most frequent reasons for ICU admission were acute infections (n=17, 89%), pneumonia (n=9, 47%), sepsis or septic shock (n=7, 37%), acute renal failure (n=6, 32%), and acute exacerbation of chronic obstructive pulmonary disease (COPD) (n=6, 32%). Some patients were admitted with several of the above cited diagnoses. All patients presented with comorbidities; the most frequent were hypertension (n=15, 79%), diabetes mellitus type II (n=9, 47%), nicotine abuse (n=8, 42%), COPD (n=7, 37%), coronary heart diseases (n=7, 37%), infectious diseases (n=6, 32%), chronic renal insufficiency (n=5, 26%), hypothyroidism (n=5, 26%), hyperlipidemia (n=5, 26%), chronic respiratory insufficiency (n=3, 16%) or obesity (n=2, 11%).