Recent Advances in Interfaces For Non-Invasive Ventilation: From Bench Studies To Practical Issues

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COPYRIGHT 2012 EDIZIONI MINERVA MEDICA
E X PE RT O P I N I O N
Recent advances in interfaces for non-invasive ventilation: from bench studies to practical issues
G. F. SFERRAZZA PAPA
1Intensive
1, 2 ,
F. DI MARCO 2, E. AKOUMIANAKI
1, 3 ,
L. BROCHARD
1, 4
Care Department, University Hospital, Geneva, Switzerland; 2Clinica di Malattie dellApparato Respiratorio, Ospedale San Paolo, Universit degli Studi di Milano, Milano, Italia; 3Department of Intensive Care Medicine, University Hospital of Heraklion, Heraklion, Crete, Greece; 4University of Geneva, Geneva, Switzerland
ABSTRACT
The interface is the defining element of non-invasive ventilation (NIV). Nowadays different types of interfaces, which differ in terms of shape, mechanical properties and comfort, are available, and their choice and fitting is a key element of NIV success. In the last decade, larger masks covering the entire face and specifically designed helmets have been developed for delivering NIV, theoretically improving comfort and patient tolerance. Recent studies have shown that, despite marked heterogeneity in mask internal volume and compliance, the dynamic dead space and, above all, the clinical efficacy of different masks is on average very similar. Thus, with the exception of the nasal mask and the mouthpiece, a variety of interfaces for NIV can be used in the acute care setting. However, prevention and monitoring of interfaces related side-effects and evaluation of patient tolerance are crucial to avoid NIV failure. To optimize effectiveness and costs, an interface strategy for NIV in acute respiratory failure could be convenient in clinical practice. (Minerva Anestesiol 2012;78:1146-53) Key words: Positive-pressure respiration - Masks - Respiratory insufficiency.
on-invasive ventilation (NIV) is a form of delivering ventilatory support without the use of endotracheal or tracheostomy tube. Several prospective randomized controlled trials have shown that NIV reduces the need for intubation and in-hospital mortality of patients with acute exacerbation of chronic obstructive pulmonary disease and acute cardiogenic pulmonary edema, in such a way that NIV is nowadays the firstline treatment for hypercapnic acute respiratory failure (ARF).1, 2 NIV proved its effectiveness also after surgery, as support during fiberoptic bronchoscopy, for the prevention of respiratory failure after extubation, and in selected patients with ARF.3-7 Apart from clinical trials, there has been also a progressively increased use of NIV in clinical practice.8-10 Notably, in patients treated with
NIV outside trials, clinical outcomes are roughly the same as in clinical studies, meaning that this technique is well mastered by caregivers.10 The growing interest on NIV has led to research interest in developing technical components of NIV,11-18 particularly the interfaces which could affect the outcome, as shown by Navalesi et al.19 The interface is an essential component since it differentiates NIV from invasive mechanical ventilation. Great attention has been paid to the improvement of NIV related side effects,20 with special regard for patient comfort, user-friendliness, and safety. Nevertheless, it still fails in about one third of patients.10 Even if causes of treatment failure are not entirely clear, patient selection, and the role of the interface seem to be key issues.21-23 After an overview of different interfaces for
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This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this Article. It is not permitted to make additional copies (either sporadically or systematically, either printed or electronic) of the Article for any purpose. It is not permitted to distribute the electronic copy of the article through online internet and/or intranet file sharing systems, electronic mailing or any other means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame or use framing techniques to enclose any trademark, logo, or other proprietary information of the Publisher.

recent advances in interfaces for non-invasive ventilation SFERRAZZA PAPA
NIV, this paper will briefly review the most recent selected contributions providing new findings on interfaces for NIV, focusing mainly on the acute care setting. General features of interfaces for NIV Nowadays a variety of interfaces is available (Figures 1-3). A first distinction, of crucial importance, concerns leaky masks for single-circuit ventilators versus masks without intentional leaks for double-circuit or for a single circuit equipped with an expiratory valve. Beside commercially available masks, custom-fabricated also exist. The latter is directly molded on patient face, but the fabrication needs additional time of up to 30 minutes for a skilled operator, complicating the use in the acute care setting.22, 24 Even if masks formed by a unique piece of material still exist, interfaces are generally made
Figure 3.The helmet.
of two or more parts hooked or glued together: a frame made of stiff trasparent material and a cushion of soft material to seal the frame against patient face.2, 22 Improvements have been realized by using different cushions with new materials (such as hydrogel), and in the fixing system with particular attention to skin and eyes care. The increase in the number of the attachment points permits a more uniform distribution of pressure, resulting in a major tolerance and in reduced leaks. Larger frames covering the entire face and specifically designed helmets have been proposed for NIV.3 The role of these new devices has been the subject of dedicated bench and physiological studies.11-13, 15, 18 The oronasal mask All interfaces for NIV deliver positive pressure either through the mouth, the nose or both. The oronasal mask (Figure 1) is the most widely used in the ICU, since patients with ARF often have a high respiratory drive and are generally mouth-breathers probably to overcome nasal resistance.8, 10, 23 These masks are disposable and are available in different sizes and shapes to fit better at patient face. The full-face mask
Figure 1.The oronasal (on the left) and the full-face mask (on the right).
Figure 2.Nasal and oral interfaces.
The full-face, or total face mask covers the entire face including the eyes (Figure 1).25 This
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SFERRAZZA PAPA recent advances in interfaces for non-invasive ventilation
interface has a large inner volume and it is fixed with a soft seal around the face. Through its large perimeter it avoids pressure over the nasal bridge, which is frequently exposed to pressure sores as the skin is thin and directly upon the bone. Total face mask is designed as one size which should fit most patients, making theoretically easier mask fitting in acute patients. A recent study found no difference on this issue in comparison with oronasal mask, having both the same level of perceived comfort, and similar application time.15 However, the limitation of this study is its shortterm nature, whereas differences in tolerance may be clinically relevant over longer periods. Noteworthy, this type of mask is generally more expensive than oronasal masks, and it is single use, for this reason it is often suggested as a second line intervention (Figure 4).22 Nasal interfaces There are two existing types of nasal interfaces: nasal masks, designed to cover either the full nose or the nares only, and nasal pillows
directly inserted into the nostril.2 The nasal interfaces have the obvious limitation of nonintentional leaks if patient breathe through the mouth, which is frequent for patients exhibiting a high ventilatory demand. Furthermore, it cannot be used in case of nasal obstruction or congestion. On the other hand, this kind of interface permits patients to eat, talk, cough, and causes less claustrophobia. Therefore, it is mostly used for chronic NIV, while in acute setting the improvement in gas tension appears to be slower compared to face masks. The use of a nasal mask in the ICU is clearly not recommended since it leads to mask failure in more than 70% of the patients.26 Oral interfaces Oral interfaces, such as the mouthpiece, are placed between patient lips delivering pressure directly into the mouth, thus nasal clips are sometimes used to avoid nasal leaks. Different shapes and sizes of this interface exist and it is used particularly for neuromuscular disorders
Figure 4.An interface strategy for non-invasive ventilation in the acute care setting. Non leaky masks with intensive care unit ventilator. # If patient non adapted verify also settings, leaks and asynchronies. NIV: non-invasive ventilation.
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requiring long-term ventilation. Since there is no contact with the nasal bridge, some centers propose the alternate use of oral and nasal interfaces for patients who need nearly continuous ventilatory assistance.2, 27 In the ICU, it is however associated with significantly more leaks and asynchrony and requires a very cooperative patient.13 The helmet The helmet, originally used to deliver the desired oxygen fraction during hyperbaric oxygen therapy, was first proposed for delivery continuous positive airway pressure (CPAP), and subsequently for NIV.3, 28 It holds the entire head of the patient by means of a transparent hood fixed softly around the neck or the shoulders (Figure 3). The helmet, available in different sizes, is connected to the ventilator with two tubes, for the inspiratory and expiratory circuits. Noteworthy there are dedicated helmets for CPAP, provided with a pipe-connector for the PEEP valve (e.g. spring-loaded, or water-seal), which need only a high flow air-oxygen source. Since it has no contact with the face, the helmet allows patient to cough, see and talk, with supposedly a better comfort and tolerance of the patient, even if specific problems may arise as the possible occurrence of axillary decubitus.3, 28 Several studies, mainly with short-term outcomes, found conflicting results on these issues.3, 29-33 The helmet should be used only with high flow to avoid important rebreathing and it exposes patients to a high level of noise, reason why most of them are now provided with ear plugs. For NIV this interface should be used by an experienced team due to the lack of volume monitoring, and the risk of asphyxia.7, 22, 28, 34, 35 Bench studies Proper functioning of the interface, leaks management and effectiveness of NIV are directly linked. Air leaks can reduce delivered volumes, represent a discomfort for the patients and affect patient-ventilator synchronization.9, 36 In general, leaks should be minimized but NIV, by definition, has to work in the presence of gas
leaks. Recent bench studies reproducing leaks focused on this topic. Louis et al. compared the leak levels of several masks on the performance of four single circuit NIV ventilators with an exhalation port in the mask, also referred to as intentional leaks.37 The leak level affected substantially ventilator performance and patientventilator synchronization. The mask with the largest leak was associated with auto-triggering and/or a decreased inspiratory-trigger sensitivity. At the opposite, the interfaces with the smallest leak were associated with important rebreathing. A physiological study on four volunteers confirmed the main results of the study.37 The risks of low levels of intentional leaks due to low positive end-expiratory pressure (PEEP) levels have been studied.38 Borel et al. showed the effects of mask leaks on efficacy of NIV with an active lung simulator.39 With the settings tested (respiratory rate 15 cycles/min, inspiratory and expiratory pressure of 14 and 4 cmH2O, and different compliance and resistance levels) they confirmed that intentional leaks higher than 40 L/min had an impact on the capacity to reach the set inspiratory pressure and thus in delivering the target tidal volume. A compromise in terms of leaks intensity has to be found depending on the risk of rebreathing versus the need for delivering high pressures. The various types of interfaces are characterized by marked heterogeneity in mask internal volume, compliance and mechanical properties. A general concern over the new interfaces having a large internal volume is the risk of rebreathing. Fodil et al. specifically studied this risk by using numerical simulations (using computational fluid dynamic) in four types of NIV interfaces, two oronasal masks, a total face mask and a helmet.12, 14 In this in vitro study, the authors showed a large difference between the internal volume of mask (which is about 10 L for the helmet) and the dynamic effective dead space, which can be much smaller due to the streaming effect of gases.12 These results, in line with the physiological findings described below,11, 13 suggested that new masks should be tested in terms of functional dead space 40 and that internal volume itself should not be a priori a limiting factor for mask selection.
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Physiological and clinical studies Fraticelli et al. studied the effect of four interfaces a mouthpiece, a facial mask, and two oronasal interface (with small and large internal volume) on minute ventilation, gas exchange and work of breathing of patients with ARF.13 Despite heterogeneity in the internal volume of the devices, the authors found no difference in short-term physiological parameter in terms of indexes of respiratory effort (pressure-time product, PTP), arterial blood gases and breathing pattern. The only exception was the mouthpiece being less tolerated. Another recent study supported the hypothesis that different types of masks are largely interchangeable.11 In 34 acute patients with acute hypercapnic respiratory failure, Cuvelier et al. compared the clinical efficacy of full-face vs. oronasal mask. They found no difference in the effectiveness of NIV delivered with these two masks (the main outcome was pH 24 hours after NIV start) despite marked differences in the inner volume of the masks. A specifically conceived helmet has been described for NIV.3 This interface is characterized by a large internal volume reflecting an ancient idea of pressurisation inside a bubble.41 Due to high compliance, the helmet can be less efficient in reducing inspiratory effort, and promoting patient-ventilator synchrony than the oro-nasal mask, as indicated by higher triggering and cycling-off time delays by the larger number of ineffective efforts.34 This problem can be solved or minimized by using specific settings, i.e., higher pressures. Vargas et al. compared pressure-support ventilation delivered with a facemask and two helmets, one with the same ventilatory settings of the mask and the other with 50% higher pressure support and PEEP. The study was performed in eleven patients requiring NIV after extubation for high risk of respiratory distress.18 When using the same settings, the helmet resulted in higher PTP, which reflects a less effectiveness in unloading the inspiratory muscle; however, using higher settings this difference was abolished. Synchrony, tolerance and comfort in NIV: the role of the interface During NIV, both the patient and the venti-
lator contribute to generate a pressure gradient, thus optimal patient-ventilator synchronization is extremely important. Vignaux et al. found in 60 patients with ARF ventilated with an oronasal mask a high prevalence of severe asynchronies (43% of patients with a global asynchrony index >10%).36 In this observational study, ineffective efforts and the severity of delayed cycles were linked with the amount of leaks. Moreover, a multivariate analysis showed that patient comfort scale was higher if the asynchrony index was less than 10%. However, whether all kind of asynchronies have the same clinical impact is unclear, and there was no correlation between asynchronies and clinical outcome. Larger masks are designed to improve comfort and easy-to-use. In 60 patients with ARF, Ozsancak et al. tested the hypothesis of the theoretical superiority of the total face vs. the oronasal mask on patient comfort and rapidity of application by caregivers.15 In a randomized controlled trial, they found that both interfaces were perceived as similarly comfortable by patients and required roughly the same time for mask fitting (median 3.5 vs. 5 min, P>0.05.). Contrary to the study hypothesis, the total face mask resulted in a strong trend towards a more early discontinuation due to interface intolerance (39% vs. 16%). The beginning of NIV plays a pivotal role in the success of treatment. In 90 patients with hypercapnic ARF, Girault et al. studied the role of the initial mask choice (nasal vs. oronasal mask) on clinical effectiveness and tolerance of NIV.26 Although an improvement in respiratory parameters was similar in the two groups, leaks with the nasal mask resulted in a considerably higher rate of treatment failure, and the need to change interface when compared to oronasal mask. The mouthpiece has been proposed to deliver NIV, but its use in the acute care setting is difficult because of the mandatory need for cooperation and the impossibility of breathing through the nose in patients with high ventilatory needs.27, 42, 43 Moreover, a recent study showed a significant increase in asynchronies, non-intentional leaks and poor comfort with the oral interface, suggesting that this device is probably more suitable for chronic patients.13 In the previously described study by Vargas et
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al., patient-ventilator synchronization was better with the facemask than with the helmet due to longer delay in triggering and cycling-off with the second (P<0.05) but an increase of PEEP and pressure support resulted in a significant shortening of the triggering delay. In those patients, no difference in tolerance was shown.18 In post-abdominal surgery delivering CPAP with a helmet was well tolerated and reduced the incidence of endotracheal intubation in hypoxemic ARF.44 Moreover, a recent study on 40 patients with hematologic malignancy has shown interesting results with the use of the helmet for prevention of acute lung injury; however, it is not clear if this effect is specific of this interface or due to early CPAP therapy.45 Neurally adjusted ventilatory assist (NAVA) is a mode of ventilatory assistance in which the ventilator is driven by electromyography of the diaphragm recorded through an esophageal catheter.46 This new mode is not dependent on the amount of non-intentional leaks and, being neurally driven, is theoretically the best mode in terms of synchronization. Preliminary data suggest a possible role of NAVA in delivering NIV. Cammarota et al. found that, in ten hypoxemic patients after extubation, NAVA delivered by helmet improved patient-ventilator interaction and synchrony compared to PSV.47 Even if NAVA theoretically could overcome some of the helmet problems, nowadays there is a lack of clinical data concerning long-term outcomes. Moreover, the need for an esophageal catheter represents a limit for a large diffusion of this technique. Practical issues In the light of the studies previously discussed we propose a simple flow-chart approach for the choice of the interface in the acute setting (Figure 4), and some practical suggestions in Table I.48 The oronasal mask appears to be the most convenient first choice interface. The mouthpiece has been demonstrated to be less effective; the nasal mask, even if comfortable, does not offer a favorable outcome in patients with respiratory distress usually breathing through the mouth. The total/full-face mask failed to dem-
Table I.Practical issues in non-invasive ventilation in the acute care setting.

Use ventilator/interfaces familiar to the staff and adapted to patient morphology (Figure 4) Use devices as tube adapter, comfort flaps, chin strap 22 Apply the mask at first with hands and then fix it Pay attention to adapt securing system Monitor leaks on the ventilator, try to reduce them but tolerate a small amount of leaks Evaluate curves 49 and, if necessary, reduce PEEP and/or PS 48
PEEP: positive end-expiratory pressure; PS: pressure support.
onstrate a clear superiority to oronasal mask in terms of clinical effectiveness and tolerability. The helmet has unfavorable mechanical properties (high compliance); moreover it does not allow a proper evaluation of ventilator pressure and flow waveforms that are important factors for NIV success in patients suffering from acute exacerbation of chronic obstructive pulmonary disease.49 The helmet can be used as a first line interface in experienced hands and for some indications like pulmonary edema. The first minutes of NIV application are crucial for its success. A general suggestion is to hold the mask gently on the patients face and progressively increase ventilator pressure, with the head of the bed elevated. Skin, eyes and mask hygiene should be evaluated periodically, with pressure points inspection (mainly the nose bridge for masks and axillary region for the helmet). In case of NIV failure due to the interface a different model of oronasal mask or a full-face mask can be used, with the choice being made in light of interfaces availability and team experience (Figure 4). To prevent nose bridge or axillary skin pressure sores, the most common approach is the application of hydrocolloids. To date there is not an ideal NIV interface for all patients in all circumstances, thus many interfaces should be available at the bedside. After the initial choice a periodical new evaluation of patient comfort and patient-ventilator synchronization is needed. When clinical stability is reached, a practical approach to reduce the risk of skin lesions can be to rotate various types of interfaces, which are characterized by different shapes and pressure points on the face.
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Conclusions The interface is of paramount importance for adherence to NIV therapy and consequently for NIV success. The choice of this device should be done with special care to meet patients demand and needs, considering the treatment timing and settings, and by preferring masks which deliver positive pressure through both the mouth and the nose in patients with high ventilatory drive.50 Bench and physiological studies on new interfaces suggests that the internal volume and the dynamic effective dead space of masks are not so closely related. Thus, with few exceptions (such as the nasal mask and the mouthpiece), interfaces are largely interchangeable in the acute care setting. To improve patient comfort, and minimize leaks, it is advisable to have multiple types and sizes of interfaces and to apply a well defined protocol adjusted to the caregiver expertise. Moreover, special focus should be put on the improvement of patient-ventilator synchrony, patient comfort and tolerance. Key messages Recent studies proved that most interfaces for NIV are interchangeable in the acute care setting with the exception of the nasal mask and the mouthpiece. Elements of key importance in providing NIV are also patient-ventilator synchrony, patient comfort and tolerance. A wide choice of interfaces types and sizes is advisable, integrated in a well defined protocol tailored on the caregiver expertise. References
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Corresponding author: L. Brochard, Intensive Care Unit, Hpitaux Universitaires de Genve, Rue Gabrielle-Perret-Gentil 4, 1211 Genve 14, Switzerland. E-mail: laurent.brochard@hcuge.ch Received on February 14, 2012 - Accepted for publication on June 22, 2012. This article is freely available at www.minervamedica.it
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Recent Advances in Interfaces For Non-Invasive Ventilation: From Bench Studies To Practical Issues

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Recent Advances in Interfaces For Non-Invasive Ventilation: From Bench Studies To Practical Issues

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COPYRIGHT 2012 EDIZIONI MINERVA MEDICA

COPYRIGHT 2012 EDIZIONI MINERVA MEDICA

Figure 3.The helmet.

Figure 2.Nasal and oral interfaces.

COPYRIGHT 2012 EDIZIONI MINERVA MEDICA

COPYRIGHT 2012 EDIZIONI MINERVA MEDICA

COPYRIGHT 2012 EDIZIONI MINERVA MEDICA

COPYRIGHT 2012 EDIZIONI MINERVA MEDICA

Table I.Practical issues in non-invasive ventilation in the acute care setting.

COPYRIGHT 2012 EDIZIONI MINERVA MEDICA

COPYRIGHT 2012 EDIZIONI MINERVA MEDICA

24. 25. 26.

40. 41. 42. 43.

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