Peak Expiratory Flow During Mechanical Insufflation-Exsufflation: Endotracheal Tube Versus Facemask

doi:10.21203/rs.3.rs-229447/v1

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Peak Expiratory Flow During Mechanical Insufflation-Exsufflation: Endotracheal Tube Versus Facemask

https://doi.org/10.21203/rs.3.rs-229447/v1

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Background: Mechanical insufflation-exsufflation (MI-E) applied through the endotracheal tube (ET) can effectively eliminate airway secretions in intubated patients. However, the effect of the interface (ET vs. facemask) on expiratory airflow generated by MI-E has not been investigated. This study aimed to investigate the effect of the ET on peak expiratory flow (PEF), along with other associated factors that could influence PEF generated by MI-E.

Methods: Intubated participants received two sessions of MI-E via ET therapy per day for two consecutive days. One MI-E session consisted of five sets of either constant (+40/-40 cmH₂O) or incremental (+30/-30 to +50/-50 cmH₂O) pressure applications. Following extubation, MI-E sessions were repeated using facemask. Expiratory airflow during MI-E therapy was measured, and repetitive PEF measurements during each session were analysed using linear mixed-effect and generalised linear mixed models.

Results: A total of 12 participants (9 [75.0%] men; mean [SD] age, 74.0 [10.2] years) completed all MI-E sessions with both ET and facemask interfaces. The PEF generated during MI-E treatment was influenced by the pressure gradient, number of session repetitions, and interface (ET vs. facemask). Adjusted mean PEF values for MI-E via ET and facemask at +40/-40 cmH₂O were -2.521 and -3.114 L/s, respectively, and -2.956 and -3.364 L/s at +50/-50 cmH₂O, respectively. At a pressure gradient of +40/-40 cmH₂O, only 172 of 528 MI-E trials via ET (32.6%) achieved a PEF faster than -2.7 L/s, whereas 304 of 343 MI-E trials via facemask (88.6%) exceeded the PEF cut-off value.

Conclusions: MI-E via ET generated slower PEF than via facemask, suggesting that a higher-pressure protocol should be prescribed for intubated patients. An insufflation-exsufflation pressure of at least +50/-50 cmH₂O should be considered to produce a PEF faster than 2.7 L/s, and the applications were safe and feasible for patients under invasive mechanically ventilation.

Critical Care & Emergency Medicine

mechanical insufflation-exsufflation

cough

endotracheal tube

mechanical ventilation

respiratory therapy

Patients in the intensive care unit (ICU)^{receiving mechanical ventilation (MV) often require frequent removal of airway secretions. Accumulated mucus, without timely removal, aggravates airway obstruction that can induce hypoxaemia, hypoventilation, pulmonary atelectasis, and ventilator−associated pneumonia[1]. Acute pulmonary infections and impaired mucociliary transport due to prolonged immobility, in addition to the use of sedatives, worsen the accumulation of large amounts of airway secretions[2]}.Endotracheal suction through the endotracheal tube (ET) has been commonly applied to maintain airway hygiene in the ICU. However, only the secretions from the larger proximal airways can be cleared using endotracheal suctioning, because negative pressure can only be directly applied within a limited area of the bronchial tree[2, 3]. Mechanical insufflation-exsufflation (MI-E) inflates the lungs using positive pressure and then abruptly shifts to negative pressure across all airways to simulate the physiologic cough, which facilitates the movement of secretions from the peripheral to the central airways[4]. Application of MI-E in the ICU could be another strategy to effectively remove secretions in intubated patients[5–7]; however, there is insufficient evidence regarding the efficiency of sputum removal using MI-E compared with conventional endotracheal suctioning or physiotherapy. Previous studies have used different outcome measures and have drawn inconsistent conclusions about the effectiveness of MI-E in the ICU[8, 9]. Additionally, the applied insufflation-exsufflation pressures ranged from + 30/-30 cmH₂O to + 50/-50 cmH₂O with no consensus regarding the optimal pressure settings[3, 10–12]. These differences in protocol hinder current research on the effectiveness of MI-E during critical care.

The ET interface can reduce the diameter of the main bronchi and increase the total airway resistance, which might result in slower expiratory airway flow compared with the facemask (FM) interface[13]. However, the effect of the ET on expiratory airflow during MI-E therapy has not yet been examined. In this study, we compared peak expiratory flow (PEF) during MI-E therapy via ET before extubation, and via FM after extubation, in the same participants. Through these comparisons, we investigated the effect of the ET on PEF, along with other associated factors that could influence PEF generated by MI-E. The results of this study are expected to provide evidence upon which to base future protocols for MI-E therapy in intubated patients.

Study participants

We recruited patients receiving MV in the ICUs of a single tertiary centre hospital who require MI-E therapy owing to large amount of secretions. From June 2019 to July 2020, a total of 452 patients were consulted for ICU rehabilitation treatment, and only intubated patients on any mode of ventilation without requiring extubation within 24 hours were recruited for MI-E therapy through ET (n = 210). Patients deemed too unstable for MI-E therapy initiation (positive end-expiratory pressure [PEEP] > 8 cmH₂O, ratio of arterial oxygen partial pressure to fractional inspired oxygen < 150 mmHg, respiratory rate (RR) > 35/min, heart rate (HR) > 130 bpm, systolic blood pressure < 90 or > 160 mmHg, and diastolic blood pressure < 50 or > 110 mmHg) (n = 64); patients with contraindications to MI-E such as active communicable respiratory infections, barotrauma, or pneumothorax within 1 month (n = 52); and patients who declined or were unable to participate (n = 73) were excluded from the study[10, 14, 15]. A total of 21 patients were enrolled as participants in the study to receive MI-E therapy through ET and FM. The Institutional Review Board (IRB) of the Ethical Committee of Seoul National University Hospital approved and monitored the study in accordance with the Declaration of Helsinki (IRB No. 1907-114-104).

MI-E protocol

After obtaining informed consent from the participants or their legal guardians, each participant was scheduled for two MI-E sessions via ET therapy per day for two consecutive days. Since the timing of extubation varied according to individual medical conditions, the total number of of MI-E sessions via ET also varied up to a maximum of four.

The participants were divided into two groups, as shown in Fig. 1. In Group I, the pressure was increased from + 30/-30 to + 50/-50 cmH₂O in the first MI-E session; in Group II, a constant pressure of + 40/-40 cmH₂O was used for the entire first session. For the second session on day one, the pressure settings were reversed for each group in order to evaluate the effect in the same participants of different pressure application strategies (constant vs. incremental) on airflow generated through the ET (Fig. 1a). The same pressure settings as those used in the first session on day one were applied for both sessions on day two to evaluate the effects of the number of MI-E treatment sessions on airflow (Fig. 1b). After extubation, MI-E via FM with the same pressure protocols as those used on day one were employed to investigate the effect of the interface (ET vs. FM) on airflow (Fig. 1c).

One cough cycle comprised 3 s of insufflation, 2 s of exsufflation, and 2 s of pause, with a total of five consecutive coughs (repetitions) within one set. All patients received a total of five sets per treatment session with a rest period of < 2 min between each set. Longer insufflation followed by shorter exsufflation was chosen based on previous results from the lung-model analysis to simulate the physiology of a cough[16–18].

Measurements

The Cough Assist E70™ (Phillips-Resperonics, USA) was serially connected to a flowmeter (Citrex™ H4 Gas Flow Analyser, IMT Analytics AG, Switzerland), a single-use antibacterial filter, and either the ET or FM interface (Fig. 2). The flowmeter was calibrated and validated annually by IMT Analytics, wherein the confirmed maximal uncertainty error was ≤ 0.75% for all measurements. Insufflation-exsufflation airflow was measured every 0.001 s during the entire treatment session. The primary outcome was PEF (in L/s): the lowest value of airflow measured during exsufflation since the value was measured and analysed with negative signs.

The secondary outcomes were the feasibility and safety of MI-E therapy when using ET and FM interfaces with pressures ranging from + 30/-30 to + 50/-50 cmH₂O. These outcomes were evaluated using the percentage of session completion and the number of adverse events that occurred during the application of MI-E therapy. Adverse events were defined as systolic blood pressure increase > 20%, mean arterial pressure decrease > 15% from baseline, HR ≥ 140 bpm or increased > 20% from baseline, peripheral oxygen saturation < 85% even after oxygen administered for a maximum of 2 min, RR increase > 50% from baseline, and/or RR > 35/min. Participants were also asked to report any discomfort (e.g., dyspnoea, dizziness, nausea, worsening of gastro-oesophageal reflux, chest or abdominal discomfort) during or after MI-E therapy[4, 14], and to report their satisfaction with the treatment using a 5-point Likert scale: from 1 = ‘very dissatisfied’ to 5 = ‘very satisfied’ if they were able to respond to the questions (Richmond Agitation-Sedation Scale[19] score between − 1 and + 1). Simple chest radiographs were evaluated daily until the day after the completion of the MI-E therapy sessions to confirm that no complications, such as pneumothorax or pneumomediastinum, had occurred[15].

Demographic characteristics (age, sex, body mass index), ICU admission type, reasons for ICU admission, severity measured by the Acute Physiology and Chronic Health Evaluation score[20], ET diameter, and MV duration were gathered from medical records.

Statistical analysis

As repeated measurements from the same patient were correlated, a linear mixed-effect model (LMM) was used with PEF as the dependent variable[21]. The model included applied pressure, number of MI-E treatment sessions, number of coughs (repetitions) within each set, assigned group (Group I or II), interface (ET vs. FM), and any relevant interactions between a given pressure gradient and interface or number of sessions on PEF. The variabilities between participants were included as random effects. Additionally, a generalised linear mixed model (GLM) of binary logistic regression was applied to evaluate the variables related to effective exsufflation flow through MI-E treatment, defined as PEF <-2.7 L/s. The cut-off value of -2.7 L/s for PEF was chosen based on the study from JR Bach[22], which suggests that peak cough flow of 160 L/min (2.7 L/s), whether assisted or not, is the minimum expiratory airflow required to sufficiently clear secretions in patients with artificial airways[13, 22]. Other clinical and demographic characteristics were analysed using descriptive analyses. Statistical analysis was performed using SPSS version 25 (SPSS, Inc., Chicago, IL), and a p-value < 0.05 was considered statistically significant.

Demographics of participants

Of the 21 participants recruited, two were excluded because they could not cooperate with the insufflation-exsufflation cycle of MI-E therapy. That is, they could not coordinate their inspiration with 3 s of insufflation, and they coughed too early during this phase, such that no air remained to effectively cough out during the exsufflation phase.

The remaining 19 participants completed the MI-E therapy via ET. However, three participants (two from group I and one from group II) declined additional MI-E treatment via FM because they did not have substantial secretions after extubation. Four participants (two from group I and two from group II) could not receive MI-E therapy via FM because they underwent planned tracheostomy immediately after extubation. A total of 12 participants (six from each group) completed all the MI-E sessions with both ET and FM interfaces. The participants’ characteristics are presented in Table 1.

Table 1
Characteristics of the participants.
Characteristics	Study Population (n = 12)
Age (years)	74.0 ± 10.2
Female	3 (25.0%)
BMI	21.1 ± 3.16
APACHE II (at ICU admission)	19.5 ± 9.35
ICU type
Medical	3 (25.0%)
Cardiovascular	7 (58.3%)
Surgical	2 (16.7%)
Main cause for ICU admission
ARDS	5 (41.7%)
After thoracic surgery	7 (58.3%)
P/F ratio (mmHg)	286.14 ± 76.73
PEEP	5.42 ± 1.24
ET size (mm); internal diameter
6.5	1 (8.3%)
7.0	4 (33.3%)
7.5	6 (50.0%)
8.0	1 (8.3%)
Intubation period	6.83 ± 3.69
*Numbers are presented as mean ± standard deviation or number(percentage)
*BMI: body mass index, APACHE: Acute Physiology and Chronic Health Evaluation, ICU: Intensive Care Unit, ARDS: Acute Respiratory Distress Syndrome, P/F ratio: ratio of arterial oxygen partial pressure(PaO2) to fractional inspired oxygen(FiO2), PEEP: positive end-expiratory pressure, ET: endotracheal tube.

Feasibility and safety of MI-E application through ET

No adverse events with respect to haemodynamic instability were reported during or after the application of MI-E at all pressure stages to + 50/-50 cmH₂O. None of the participants rejected the completion of the incremental pressure protocols via both ET and FM. Among the eight participants who were able to answer the questions, no treatment-related discomfort was reported; however, one participant reported nausea after MI-E through the ET, which resolved within five minutes. Eight out of the twelve participants provided their responses for the Likert scale of satisfaction; average scores of 3.6 and 3.9 were reported for MI-E via ET and FM, respectively. When asked which interface they found more comfortable, four participants preferred ET, three preferred FM, and one considered both interfaces to be similarly comfortable.

Determinants of PEF during MI-E use

The LMM analysis demonstrated that the interface (ET vs. FM), pressure, and number of treatment sessions were factors associated with PEF (Table 2). Compared with PEF generated at + 30/-30 cmH₂O, the increasing pressure gradient generated faster PEF (negative number of effect estimates for PEF difference represents faster velocity). Compared to MI-E with FM, MI-E through ET resulted in slower PEF (positive number of effect estimates for PEF difference represents slower velocity). However, the assigned pressure setting protocol (Group I or II) was not associated with the velocity of the PEF.

Table 2
Linear mixed-effect model analysis for peak expiratory flow (PEF).
Predictor	p-value	Effect estimates for PEF difference (L/s) [95% Confidence Interval]
Pressure setting protocol (constant vs. incremental)	0.542
Number of treatment session	< 0.001^*
Repetitions within set	0.057
Pressure	< 0.001^*	+ 30/-30 cmH₂O (reference)
	+ 30/-40 cmH₂O	-0.365 [-0.578 ~ -0.153]†
	+ 40/-40 cmH₂O	-0.500 [-0.666 ~ -0.334]
	+ 40/-50 cmH₂O	-0.715 [-0.928 ~ -0.502]
	+ 50/-50 cmH₂O	-0.852 [-1.065 ~ -0.639]
Interface (Endotracheal tube vs. Facemask)	< 0.001^*	Facemask (reference)
	Endotracheal tube	+ 0.480 [0.358–0.602]‡
Interaction
Interface *Pressure	0.023^*
Number of treatment session *Pressure	< 0.001^*
^*p-value < 0.05.
† Negative number of effect estimate for PEF difference represents faster velocity.
‡ Positive number of effect estimate for PEF difference represents slower velocity.

In the analysis of the GLM, the factors related to whether PEF exceeded the cut-off value of -2.7 L/s were number of treatment sessions, interface (ET vs. FM), and pressure—the same factors reported from the LMM analysis (Table 4).

Table 4
Generalized linear mixed model analysis for predicting whether peak expiratory flow reaches 2.7L/s.
Predictor	p-value	odds ratio [95% Confidence Interval]
Pressure setting protocol (Constant vs. Increasing)	0.718
Number of treatment sessions	< 0.001^*
Repetitions within set	0.306
Pressure	< 0.001^*	+ 30/-30 cmH2O (reference)
	+ 30/-40	5.856 [1.883–18.211]
	+ 40/-40	58.426 [22.728–150.193]
	+ 40/-50	187.002 [54.270–644.371]
	+ 50/-50	862.923 [235.437–3,162.784]
Interface	< 0.001^*	Face mask (reference)
	Endotracheal tube	0.006 [0.003–0.014]
^*p-value < 0.05.

PEF differences according to interfaces: ET vs. FM

Both pressure and the interaction between interface type and pressure were correlated with PEF (Table 2). Therefore, the amount of increase in PEF because of the increase in the pressure gradient was different depending on the interface. Adjusted mean PEF was calculated assuming that the covariables other than the pressure gradient (i.e., number of treatment sessions, assigned group for pressure setting protocol, and number of coughs within a set) were fixed to the average values. For each pressure gradient, PEF via ET was always slower than that generated via FM. The PEF increased continuously with higher pressure when using ET, whereas no more increase of PEF was obvious from + 40/-50 to + 50/-50 cmH₂O with FM (Table 3).

Table 3
Comparison of peak expiratory flow during mechanical insufflation-exsufflation according to the interfaces: endotracheal tube vs. facemask.
Pressure(cmH₂O)	PEF via endotracheal tube (L/s)	PEF via facemask (L/s)
+ 30/-30	-2.181 [-2.372, -1.991]	-2.661 [-2.850, -2.472]
+ 30/-40	-2.369 [-2.559, -2.179]	-2.995 [-3.184, -2.807]
+ 40/-40	-2.521 [-2.700, -2.341]	-3.114 [-3.293, -2.935]
+ 40/-50	-2.731 [-2.921, -2.541]	-3.326 [-3.515, -3.137]
+ 50/-50	-2.956 [-3.146, -2.766]	-3.364 [-3.552, -3.175]
Numbers are adjusted mean peak expiratory flow(PEF) [95% confidence interval].
Adjusted mean PEF were calculated using other covariables (number of treatment session, assigned group for pressure setting protocol, and number of coughs with a set) assumed to be fixed as constant average values.

The Fig. 3 shows that the PEF generated with each application of MI-E became faster as a higher pressure gradient was applied via ET or FM. When a pressure gradient of + 40/-40 cmH₂O was applied, only 172 of 528 MI-E trials via ET (32.6%) achieved a PEF faster than the − 2.7 L/s cut-off value, whereas 304 of 343 MI-E trials via FM (88.6%) exceeded the PEF cut-off value. Even at + 50/-50 cmH₂O of pressure gradient, 66 of 85 MI-E via ET trials (77.6%) reached a PEF <-2.7 L/s, whereas 55 of 60 MI-E via FM trials (91.7%) reached the cut-off value.

This study reveals that the PEF generated during MI-E treatment was influenced by the pressure gradient, number of session repetitions, and interface. When applying MI-E via the ET interface, a higher pressure gradient is recommended to obtain a PEF equivalent to that when using the FM interface.

Although several studies still selected a pressure of + 40/-40 cmH₂O for MI-E through ET[3, 23, 24], more recent studies have reported the feasibility and safety of MI-E use via ET with pressures up to + 50/-50 cmH₂O[10, 11]. Additionally, our study reported that a pressure of + 50/-50 cmH₂O was more beneficial in generating faster PEF and was safe and feasible for all participants. These results are in line with previous bench studies with a lung model, which recommended pressure higher than + 40/-40 or + 50/-50 cmH₂O in patients with artificial airways or higher airway resistance[13, 25].

Non-physiologic high peak inspiratory pressure applied during MV support may cause lung function deterioration[26, 27]. Prolonged application of high inspiratory pressure can increase transthoracic hydrostatic pressure, causing ventilator-induced oedema and subsequently disturbing pulmonary epithelial or endothelial permeability. Therefore, low tidal volume and low plateau pressure are conventionally preferred to prevent ventilator-induced lung injury (VILI). An inspiratory pressure lower than 30 cmH₂O is usually recommended in intubated patients[28]. However, there has been little evidence for inducing VILI from intermittent short durations of high inspiratory pressure, such as in MI-E treatment. Meanwhile, many studies that applied MI-E using a pressure of up to + 50/-50 cmH₂O reported improved lung conditions immediately after the treatment[10, 29].

In terms of exsufflation, -50 cmH₂O is less negative pressure than that physiologically produced by a cough or negative pressure delivered through endotracheal suctioning (~-80 cmH₂O). Although the Cough Assist E70™ can produce negative pressures of up to -70 cmH₂O, only pressures up to -50 cmH₂O were used in this study following previously reported protocols for patients admitted to the ICU. As shown in Table 3, when applying MI-E via ET, even when using a pressure of + 50/-50 cmH₂O, the PEF was slower than when using a pressure of + 40/-40 cmH₂O via FM. For effective elimination of airway secretions, a negative pressure below − 50 cmH₂O might be required. However, safety issues, such as atelectasis, when applying further negative pressure via ET in patients receiving MV, especially with the PEEP setting, remain to be investigated.

By analysing the physiology of a cough, a PEF range of 160–180 L/min has been proposed as the cut-off value to achieve effective secretion elimination[14, 22, 30, 31]. Therefore, a PEF of 2.7 L/s was regarded as the minimum PEF generation for successful secretion elimination during MI-E therapy in this study (Table 4). Rather than PEF, Volpe et al. reported that the difference between PEF and peak inspiratory flow was better correlated with mucus displacement in their lung model study simulating a patient on MV[18]. However, they did not suggest any cut-off value for this parameter for effective elimination of secretions. Expiratory cough volume (ECV) is another parameter for evaluating MI-E efficiency because PEF and ECV may not correlate with each other[32]. Gómez-Merino et al. reported different levels of ECV according to the insufflation-exsufflation time ratio despite equivalent levels of exsufflation flow in their bench study using a lung model with an artificial airway[16]. Additionally, if an upper airway collapse occurs during MI-E implementation, PEF can be maintained, whereas ECV is significantly reduced[33].

In this study, PEF was measured as the primary outcome, representing the effective utilisation of MI-E. However, theoretically, the linear velocity of the airstream, which cannot be measured in the human body, is an index with a better correlation with sputum removal. This is determined by the cross-sectional area of the airways as well as airflow (linear velocity = flow/cross-sectional area). Therefore, the efficiency of the elimination of secretions can be improved by increasing the linear velocity, even at a relatively slow PEF, at least around non-cartilaginous airways[34].

The airways collapse during a real cough with forced expiration when extraluminal pressure exceeds intraluminal pressure. Therefore, the collapse point in the non-cartilaginous airway when coughing may be the most advantageous point for removing sputum by reducing the cross-sectional area and increasing the linear velocity. In this case, not only PEF but also insufflation time and volume, which cause different intraluminal pressures, can affect the efficiency of sputum elimination. In contrast, PEF could better reflect the effect on secretion removal in cartilaginous airways when using MI-E than in non-cartilaginous airways because airway collapse does not occur during coughing in the cartilaginous airways. Therefore, depending on the target location for sputum removal, the strategy for MI-E use may be different.

A limitation of this study is the lack of information regarding the amount of airway secretions eliminated and the clinical benefits such as changes in SpO₂ levels after MI-E application, which should be included in future studies. Also, MI-E application strategies other than pressure gradients were not included in this study. For example, the insufflation time affects the insufflation-exsufflation volumes and eventually the efficiency of sputum removal. However, in this study, the insufflation time was fixed at 3 s.

The use of MI-E via ET generated slower PEF than did the use of MI-E via FM, suggesting that a higher-pressure protocol should be considered for intubated patients. An insufflation-exsufflation pressure of at least + 50/-50 cmH₂O was necessary to produce a PEF faster than 2.7 L/s, and the applications were safe and feasible. The factors related to PEF generation by MI-E were pressure gradient, interface, and number of session repetitions.

ECV: Expiratory cough volume, ET: Endotracheal tube, FM: Facemask, GLM: Generalised linear mixed model, ICU: Intensive care unit, LMM: Linear mixed-effect model, MV: Mechanical ventilation, MI-E: mechanical insufflation-exsufflation, PEEP: Positive end-expiratory pressure, PEF: Peak expiratory flow, VILI: Ventilator-induced lung injury

Ethics approval and consent to participate

The study was approved by the Institutional Review Board (IRB) of the Ethical Committee of Seoul National University Hospital and monitored in accordance with the Declaration of Helsinki (IRB No. 1907-114-104). Since some participants were lacking the capacity to provide consent while mechanically ventilated, written informed consent was provided by the legal guardians who were substitute decision-makers.

Consent for Publication

Not applicable.

Availability of data and materials

Any datasets and protocols used and analysed during this study are available from the corresponding author on reasonable request.

Competing interests

All authors declare that they have no competing interests with respect to the authorship, research, and publication of this article.

Funding

This study was an investigator-initiated study. This work was supported by the Seoul National University Hospital research fund (grant no. 04-2019-0380) and Korea Workers’ Compensation and Welfare Service.

Authors’ contributions

Conceptualization: Hyun SE, Shin HI. Project administration: Shin HI. Methodology and formal analysis: Hyun SE. Writing-original draft: Hyun SE, Shin HI. Writing-review & editing: Lee SM. Approval of final manuscript: all authors.

Conceptualization; Hyun SE and Shin HI,

Conceptualization: Hyun SE, Shin HI. Methodology and formal analysis: all authors. Writing

Acknowledgements

Authors appreciate the Medical Research Collaborating Centre at Seoul National University Hospital for their statistical contribution.

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Peak Expiratory Flow During Mechanical Insufflation-Exsufflation: Endotracheal Tube Versus Facemask

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Abstract

Figures

Introduction

Materials And Methods

Study participants

MI-E protocol

Measurements

Statistical analysis

Results

Demographics of participants

Feasibility and safety of MI-E application through ET

Determinants of PEF during MI-E use

PEF differences according to interfaces: ET vs. FM

Discussion

Conclusions

Abbreviations

Declarations

References

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