Eur Arch Otorhinolaryngol DOI 10.1007/s00405-013-2398-z

RHINOLOGY

Nasal douches for diseases of the nose and the paranasal sinuses—a comparative in vitro investigation Janna Campos • Werner Heppt • Rainer Weber

Received: 3 October 2012 / Accepted: 5 February 2013  Springer-Verlag Berlin Heidelberg 2013

Abstract Nasal douches are applied in great number of diseases of the nose and the paranasal sinuses. For this purpose, many different kinds of nasal douching systems have been introduced into the market. The aim of this study was to examine the irrigation characteristics of the current nasal douching systems. In this context, 26 nasal douching systems were compared regarding irrigation volume, irrigation duration, flow rate and pressure and course of the irrigation stream. The following procedure was applied: First, the spontaneous flow through the nasal douche was measured, then the flow under compression. Finally, these procedures were repeated using a nose model. Furthermore, we asked the manufacturers for information concerning possible cleaning and disinfection techniques. Douching period and flow rate highly depend on physical parameters: distance between liquid column and outlet (hydrostatic pressure) and form and size of the outlet (energy loss because of friction/turbulence). A weak irrigation stream was found in spontaneous release of the douching system when both douching pressure and flow rate offered low values. The douching of the nose model showed that the incompressible nasal douches only reached the lower nasal Parts of the manuscript were presented at the occasion of the 94th annual meeting of the Association of South-West Germany ENT Specialists from September 17–18, 2010, at Kloster Eberbach, Eltville, Germany. J. Campos (&)
W. Heppt ENT Department, Hospital of Karlsruhe, Moltkestr. 90, 76133 Karlsruhe, Germany e-mail: [email protected] R. Weber Rhinology Center, ENT Department, Philipps-University of Marburg, UKGM, Marburg, Germany e-mail: [email protected]

passage. Only the compressible nasal douching systems led to a diffuse moisturization as well as to a perfusion of the entire nasal cavity. Systematic evaluation of the different recommended cleaning and disinfection methods of the nasal douching systems is still missing. Nasal douches are often recommended in many diseases of the nose and the paranasal sinuses. In this comparative in vitro study, physical parameters and material properties of the nasal douching systems were examined for the first time. For irrigation of the whole nasal cavity and paranasal sinuses, compressible douching systems are recommended which have a minimum output pressure of 120 mbar, a good connection of the outlet to the nostril with a possible insertion into the nasal vestibule and an irrigation stream which is directed upwards (45). The material should be transparent, easy to clean and disinfect and should not contain harmful elements. Keywords Nasal douche
Nasal irrigation
Rhinosinusitis
Allergic rhinitis
Dry nose
Endonasal sinus surgery
Postoperative care

Background Nasal douches are recommended for a high number of diseases of the nose and paranasal sinuses [1–5]. So they are applied, for example, as additional therapy for chronic rhinosinusitis (CRS) (evidence grade A; SORT evidence rating system, http://www.aafp.org/afpsort.xml) [6], in allergic rhinitis (evidence grade A) [7], in the follow-up treatment of surgery of the paranasal sinus surgery (evidence grade B) [3] and for the therapy of acute rhinosinusitis in adults (recommendation grade A). Further, nasal douches are applied for additional treatment of acute

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rhinosinusitis in children (recommendation grade A), for prevention in case of susceptibility to infection (recommendation grade B) [8], for treatment of rhinitis gravidic rhinitis, nasal sarcoidosis, and Morbus Wegener (recommendation grade C) [3] as well as dry nose [9]. The assumed mechanism of action is the improved mucosal function by: •

• •

direct physical cleaning due to the irrigation of doughy mucus, crusts, debris, allergens, air pollutants, etc. [10– 12], removal of inflammation mediators [13] and improving the mucociliary clearance by improvement of the ciliary beating rate [14, 15].

Because of the frequency of diseases where nasal douches might be indicated, this subject is of high relevance. For nasal irrigation, a high number of irrigation systems and methods are offered [16]. The question if some irrigation systems are generally better than others or if there are more or less appropriate systems with regard to the clinical indication is not sufficiently clarified. Only regarding the effectiveness of postoperative irrigation, comparative studies have been performed [17–20]. Up to now, comparative investigations have not been published with regard to physical irrigation parameters and material properties. For the highest effect, a possibly extensive irrigation of the whole nasal cavity and paranasal sinuses is desirable. The indication of rhinitis/rhinosinusitis/dry nose usually concerns the whole mucosa. So based on this aspect, an appropriate rinsing has to efficiently irrigate the whole nasal space. The general physical parameters have to be suitable to allow such irrigation. The aim of the present investigation was to evaluate nasal douches/nasal irrigation systems regarding their physical rinsing parameters.

•

course of the irrigation stream, first the spontaneous flow and then the flow under compression as well as applied in a nasal model.

For evaluation of the irrigation duration, each nasal douche was filled with the maximal volume of water recommended by the manufacturer and the time was measured that water needed to pass the nasal douche by tilting the douche. This irrigation procedure was repeated three times and the mean value was calculated. For calculation of the volume flow rate, the irrigation volume was divided by the irrigation duration. The pressure was measured in each irrigation system at the maximal volume, at 2/3, and at 1/3 of the maximal volume as well as at maximal compression of the compressible nasal douches. For this purpose, a manometer (Wika Manometer AG) with a scaling of 0.005 bar and a maximal measurable pressure of 0.6 bar was used. The water was tinted in blue for recording of the irrigation stream. The irrigation stream was recorded with and without the nasal model, for compressible douches further with compression. For the investigation with the nasal model, we used a transparent nasal cast model of a maximally decongested cadaver nose made of synthetic resin. In this lateral model, the nasal septum was replaced by a Plexiglas plate so that the lateral nasal wall and the nasal cavity were visible (the authors want to thank Prof. Dr. G. Mlynski and Dr. A. Beule of the ENT Department of the University of Greifswald, Germany, for the courtesy of granting the nasal model). Further, we asked the manufacturers of the nasal irrigation systems for a statement regarding the durability of the nasal douches, the presence of a certificate of non-objection regarding the material as well as possible cleaning and disinfection procedures. In particular, we asked if the nasal irrigation systems are appropriate for microwave use.

Results Materials and methods In order to determine the nasal douches and nasal irrigation systems that are available on the German market, a systematic analysis via internet (google) with the key words ‘‘Nasenspu¨lung’’ (nasal irrigation) and ‘‘Nasendusche’’ (nasal douches) was performed (status of May 2010). The models that were found were purchased and submitted to a comparative in vitro investigation. In this context, the following parameters were evaluated for every irrigation system. • • • •

rinsing volume, duration of irrigation, volume flow, pressure, and

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A total of 26 different nasal douches/nasal irrigation systems/irrigation cans were found that are offered and used for nasal irrigation (Table 1). The term of ‘‘nasal douche’’ for very different irrigation systems and the unclear distinction to nasal irrigation cans show that there are no clear definitions. Further, it is not defined when a liquid brought into the nose may be called nasal irrigation (e.g., regarding quantity, duration, volume flow, type of application). Apparently, it is nasal irrigation when larger volumes of irrigation liquid are applied continuously from a can or when larger quantities are discontinuously applied via pump systems. However, the question of when pump spray application aiming at wetting and moistening turns into irrigation that has further effects on the nasal mucosa is not

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answered. The nasal irrigation systems vary regarding their design and their characteristics. Those are: •

plastic cans with an inlet located at the upper part and an outlet at the lower part of the system. In addition, a differentiation may be performed according to the following materials: –

–

–

–

• •

•

•

The outlet can be closed by tilting or turning. Thus, the irrigation procedure can be deliberately started or interrupted. An accidental loss of liquid at the beginning of irrigation is avoided. The inlet is closed with a lid. In this lid, a small opening is found that can be covered by a finger to achieve a similar effect as described above. The elasticity of the material determines if the irrigation system is compressible. So the nasal irrigation can be adapted to the individual requirements. For example, the volume flow or the pressure can be increased despite higher resistance. The irrigation system may be transparent or opaque. A transparent system allows the control regarding the type and quantity of the liquid that is in the irrigation system. Impurification of the container or the irrigation liquid can be identified in time.

glass containers. the so-called ‘‘squeeze bottle’’ with unscrewable lid and internally located nozzle so that the inlet opening corresponds to the outlet. nasal syringes. Their application is difficult to standardize because little variation of the application of the syringe leads to important differences regarding the effect. pump spray variants that release an irrigation liquid from a hyperbaric container.

The filling volume of the nasal irrigation systems varies between 30 and 500 ml. Today, most of the irrigation systems contain a quantity of 200–250 ml that is currently considered as useful for postoperative irrigation.

Irrigation with/without compression Duration and volume flow of the irrigation depend largely on the physical parameters: the maximal distance between the head of the liquid and the outlet (hydrostatic pressure) and the shape and size of the outlet (energy loss because of friction/turbulence). For durations between 6 and 54 s, the volume flow rates amounted to between 3.9 and 27.2 ml/s. Without compression, pressures were measured between 0–10 mbar. Under compression, pressure values between 100 and 400 mbar were achieved. The nasal syringe with a maximal

pressure of 600 mbar must be considered as a distinct system. The less the friction, the stronger was the output of the nasal irrigation system and the lower was the volume remaining in the nasal douche. Without compression, a relatively strong irrigation stream could be seen with a maximal filling and a minimum pressure of 5 mbar. Limit values regarding the pressure seem to be 5 mbar at maximal filling, 3 mbar at 2/3 filling, and 1 mbar at 1/3 filling volume. Below those values, only a weak irrigation stream resulted in most of the cases. However, it must be considered that those values were in the lowest measuring range of the manometer where the scaling did not allow a desirably more distinct differentiation of the values. Regarding the volume flow it became obvious that at a value\5 ml/s the irrigation stream was usually weak while the shape of the outlet additionally played a major role. When the irrigation pressure and the volume flow showed low values each, a generally weak irrigation stream was found for spontaneous emptying of the irrigation system.

Irrigation performed in the nasal model (Figs. 1–6) Irrigation performed in the nasal model with non-compressible nasal douches or nasal irrigation cans only reached the inferior nasal meatus (Figs. 1, 2 and 3). Only the compressible nasal douches reached the middle and superior nasal meatus beside the middle meatus (Figs. 4, 5 and 6). With a minimal pressure of 120 mbar, the whole nasal space could be irrigated. An advantage became obvious for slightly compressible nasal douches, i.e., the nasal irrigation system with walls that could be squeezed easily with two fingers. This was well possible for compressible nasal irrigation containers such as ‘‘sinus rinse’’ and ‘‘RhinoDouche’’. With 250 and 400 mbar, respectively, the possible pressure that could be achieved with those nasal irrigation systems was significantly higher than for other compressible system. Considering the irrigation in the nasal model, an application angle of the outlet of the nasal douche of about 45 turned out to be appropriate to reach a possibly large surface of the interior nasal space. More exact details could not be evaluated in this model investigation. It became obvious that the distribution of the liquid in the nose depended clearly on the positioning of the outlet at the nasal entrance of the model. Parameters leading to a better irrigation, reduced loss of liquid, and resulting in irrigation also of the middle and superior meatus were: • • •

good connection of the outlet to the nostril, possibly insertion into the nasal vestibule and an irrigation stream directed upwards (45).

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123 250 6 4 1 200 34 7.4

Without cap: 1 250 10 4 2 120 33 7.7

2, 3, 4, 5

1 1 Indefinite 1 or 200x

1 1 1

250 5 3 1 140 54 4.7

1, 3, 5 ([50), 6 0

1,5

1

1 1 1

200 9 3 1 120 25 8.1

1 1

1 1

Flushing with warm water Flushing with hot water Boiling Autoclaving (121 C, 20 min) Dishwasher Steam-steriliser for baby bottles, sterilising solution Vinegar solution Milton solution H2O2

250 10 4 2 120 43 5.8

0

1 1 Indefinite 1 or 200x

1 1

Suitable for microwaves (0 = no, 1 = yes)

1 1 1

1 1

1, 5, 6

Filling volume (ml) Pressure at 3/3 (mbar) Pressure at 2/3 (mbar) Pressure at 1/3 (mbar) Pressure under compression (mbar) Rinsing time (s) Flow rate (ml/s) Cleaning and disinfection methods 1 2 3 4 5 6 7 8 9

Nasal Spa

PARI Montesol

Sinus Rinse

Rhino Douche

Das Gesunde Plus (dm)

250 5 3 1 150 51 4.9

1

1 1

500

400 X X

250 (24) (9,8)

1, 6, 9

2 1 10 y. 10

1 1 1

240

2 1

1 1

250 2 1 0 150 18 13,9

5, 6, 7; not [100 C 0

2 1 Perishable 1/2 or 100x

1 1 1

15 13

200 5 3 1

0

1 or 200x 2

2

1 0 1

30 8,3

250 5 2 0

0

1

1

1 1

1 0 1

Nd St. Benedikt (Aldi)

Incompressible Inqua

Fitne

Emser

Bu¨ttnerFrank PVC Emcur

Compressible

Plastic nasal douches

Cleaning and disinfection methods

Examiner’s evaluation Material (1 = plastic, 2 = glass, 3 = china) Transparency (0 = no, 1 = yes) Harmlessness of material according to the producer (0 = no, 1 = yes) Lockable outlet (1 = yes; 2 = no) Removable cap (1 = yes; 2 = no) Durability Replacement recommendation (in years)

Table 1 Nasal douching systems

44 4,5

200 1 0 0

0

2, 5

2

2 1

1 0 1

Sensecare (Otto)

22 9,1

200 1 0 0

2 1

1 0

Omnisan Penny = NV

28 8,9

250 0 0 0

1

2 2 2 1

1 1 1

Optisana Lidl = NV

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0

Transparency (0 = no, 1 = yes)

1

440

440

10

3

1

Suitable for microwaves (0 = no, 1 = yes)

Filling volume (ml)

Pressure at 3/3 (mbar)

Pressure at 2/3 (mbar)

Pressure at 1/3 (mbar)

33

0

1

25

0

1

4

180

2

2

1

2

7

0

0

0

30

2

2

1

1

2

24

0

1

5

130

2

2

1

1

2

6

0

0

0

100

1

3, 5, 7

At breakdown

Indefinite

2

2

1

0

3

0

2

4

100

0

1, 3, 4, 5, 6

1 or 200x

Indefinite

1

1

1

1

1

24

20

0

1

4

130

5

Indefinite

2

2

1

1

2

Rinsing time (s)

10

0

1

5

500

2

2

1

2

100

16

2

3

3

250

2

2

1

2

Pressure under compression (mbar)

27

1, 3, 5 (until 65 C), 7, 8

Cleaning and disinfection methods

10

Long 1–2

Replacement recommendation (in years)

2

2

Removable cap (1 = yes; 2 = no)

Durability

2

2

1

1

1

Lockable outlet (1 = yes; 2 = no)

Harmlessness of material according to the producer (0 = no, 1 = yes)

1

Material (1 = plastic, 2 = glass, 3 = china)

Examiner’s evaluation

18

0

2

5

300

2

2

0

1

GEK Kindernasendusche

Incompressible

Nasanita Junior

Nd Harke (Dr. Junghans Med.)

Compressible

Nd Fra¨nkel (Dr. Junghans Med.)

Nasenspu¨lka¨nnchen aus Porzellan

Nd Harke (Bu¨ttnerFrank)

China Nasenspu¨ler Harke

Nasenspu¨lkanne GEK

Nasenspu¨lkanne LOTA 500

Glass Nasenspu¨lkanne LOTA 250

Plastic Nasenspu¨lkanne JALA NETI

Nasal douches for children

Rinsing cans

Table 1 continued

(11)

600

60

0

1

1/3

4 months

2

2

1

1

1

Spritze Michael Renka (Nasaline)

Syringe

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4,2 16,7 5,5

Discussion

16,7 4,1 7,2 3,9

•

•

25,4

•

Flushing with warm water

Flushing with hot water

Boiling

Autoclaving (121 C, 20 min)

Dishwasher

Steam-steriliser for baby bottles, sterilising solution

Vinegar solution

Milton solution

H2O2

2

3

4

5

6

7

8

9

• •

1

Cleaning and disinfection methods

24,2 27,2 16,5

Incompressible Glass

The following properties seemed to be good or appropriate for nasal irrigation systems: •

Flow rate (ml/s)

Nasenspu¨lkanne GEK

Plastic

Nasenspu¨lkanne JALA NETI

Nasenspu¨lkanne LOTA 250

Nasenspu¨lkanne LOTA 500

Nasenspu¨ler Harke

Nd Harke (Bu¨ttnerFrank)

Nd Fra¨nkel (Dr. Junghans Med.)

Nd Harke (Dr. Junghans Med.)

GEK Kindernasendusche

Syringe Nasal douches for children Rinsing cans

Table 1 continued

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(5,5)

Nasanita Junior Nasenspu¨lka¨nnchen aus Porzellan

From the 26 manufacturers that were contacted with the question of durability, material properties as well as possible cleaning procedures of their nasal irrigation systems, only 16 replied. According to their replies, the majority of the nasal douches have very long and even life-long durability. The shortest durability of a nasal irrigation system was given with 4 months. The recommendation to change the system varied between 4 months and 10 years while the majority of the manufacturers recommended a change after 1 or 2 years. A certificate of non-objection regarding the material was given in every nasal irrigation system. Regarding the cleaning and disinfection procedures, generally scouring with warm or hot water was recommended, sometimes even cleaning in a dishwasher. Many nasal irrigation systems could also be cleaned by putting them into an autoclave or a vaporiser for baby bottles. Only three nasal irrigation systems seemed to be suitable for microwave.

Spritze Michael Renka (Nasaline) Compressible China

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• •

transparency of the material so that the content and the interior of the irrigation system could be verified visually (hygienic reasons), closure of the outlet so that the liquid does not discharge in an uncontrolled way at the beginning of the irrigation and the procedure can be started and interrupted deliberately, an additional small opening with removable lid to control the irrigation, compressible irrigation container so that the irrigation can be adapted individually to the needs of the patient demountable for better cleaning and disinfection, rupture safety of the material (glass or chinaware must be considered as critical), high-quality plastic to avoid pollution and ability to achieve a volume flow of at least 5 ml/s or preferably even pressure of 120 mbar.

If suitability for microwave is useful for easy and efficient disinfection of the nasal douche, still has to be confirmed by microbiological examinations. This investigation is the first to show pressure values and volume flow values of nasal irrigation. Optimal values with this regard are not known up to now. As revealed by video analysis, parallel low values of volume flow (\5 ml/s) and pressure (\5 mbar) and insufficient docking of the nasal douche to the nasal entrance are unfavorable. The nasal entrance, nasal valve, septal

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Fig. 1 Macroscopic view from medially onto model of a right nasal cavity and the right lateral nasal wall. The nasal septum is replaced by a transparent Plexiglas plate moderate to weak irrigation of the inferior nasal meatus (no compression), exterior liquid loss because of poor docking (nasal douche of St. Benedict, Aldi Company, Germany)

Fig. 2 Macroscopic view from medially onto model of a right nasal cavity and the right lateral nasal wall. The nasal septum is replaced by a transparent Plexiglas plate moderal irrigation only of the inferior nasal meatus (no compression), exterior liquid loss because of poor docking (nasal irrigation can, GEK, Germany)

deviations and the head of the inferior turbinate are mechanical obstacles stopping the irrigation flow, reducing its energy and this may lead to reflux and ends up as a weak irrigation stream into the nose that only partially reaches the nasal cavity. Only compressible nasal douches can establish an optionally higher pressure with at least 120 mbar which is appropriate to wash out the whole nasal cavity and optionally the paranasal sinuses. When nasal irrigation should be applied to scour the whole nasal cavity for moistening, cleaning, and perhaps also washing out of crusts/mucous after surgery, our

Fig. 3 Macroscopic view from medially onto model of a right nasal cavity and the right lateral nasal wall. The nasal septum is replaced by a transparent Plexiglas plate good irrigation only of the inferior nasal meatus (no compression) (nasal douche of Fitne, Germany)

Fig. 4 Macroscopic view from medially onto model of a right nasal cavity and the right lateral nasal wall. The nasal septum is replaced by a transparent Plexiglas plate strong irrigation of the whole nasal cavity during compression (250 mbar) (Squeeze bottle Sinus rinse, Neilmed, Santarosa, CA, USA)

in vitro investigation showed that only the compressible nasal douches manufactured by Bu¨ttner Frank PVC, Emcur, Emser, Nasal Spa, Sinus Rinse, Rhinodouche, Das Gesunde Plus, Nasanita junior (for children) have reached this objective. For the postoperative follow-up, the application of the sinus rinse squeeze bottle (Fig. 4) or the RhinoDouche seems to be useful. However, hygienic objection must be made because the secretion or tissue of the nose can pass over to the bottle and lead to contamination. In this context, the application of syringes cannot be considered as suitable because of the pressure that cannot be easily controlled and a continuous application is not possible.

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Fig. 5 Macroscopic view from medially onto model of a right nasal cavity and the right lateral nasal wall. The nasal septum is replaced by a transparent Plexiglas plate good irrigation of the whole nasal cavity during compression (150 mbar) (nasal douche of Das Gesunde Plus, dm Company, Germany)

Fig. 6 Macroscopic view from medially onto model of a right nasal cavity and the right lateral nasal wall. The nasal septum is replaced by a transparent Plexiglas plate good irrigation of the whole nasal cavity during compression (120 mbar) (nasal douche of Emser, Germany)

Because of the missing compressibility, glass systems are only applicable when a diffuse irrigation and moistining of the inferior, in some cases, also the middle meatus is desired. The authors think that they should not be recommended because of safety objections. Since lately, two systems are available that are suitable for children that have a reduced irrigation volume. The nasal douche Nasanita junior is compressible, the insertion device can be moved and closed and the nasal douche can be fully demounted. The GEK nasal douche for children is rigid with a long outlet. It cannot be closed. In cases of maximal or extensive congestion, a general liquid tailback occurs in the nasal cavity because the

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affluent is higher than the effluent flow so that a passive filling results. This favors the diffuse moistening; however, on the other hand, it complicates a direct mechanical washing up effect, e.g., at the entrance of the paranasal sinuses after endonasal sinus surgery. Other important factors for the quality of nasal irrigations systems are the stability and the storage. The safety itself depends on the material properties. Over time, nasal douches can be contaminated bacterially without evidence that there is a clinical correlation to proven contamination [21, 22]. So, a regular cleaning and/ or disinfection and an exchange of the irrigation systems are recommended. With regard to cleaning and sterilisation, different procedures are suggested by the manufacturers: scouring with warm or hot water, decocting, putting it into the dishwasher or a vaporiser for baby bottles, vinegar solution, and Milton solution. Scientific investigations reporting on the value of those procedures could not be found in the literature. The sole rinsing with warm water is certainly not sufficient to eliminate contamination. There are current investigations showing that disinfection of nasal douches is possible with microwave [21, 23]. They still need to be further proven and confirmed for products available in Germany. Studies are missing after what time a nasal douche should be exchanged. The limitations of this study consist in the fact that different degrees of mucosal congestion could not be considered. The investigations only refer to the maximal degree of decongestion of the mucosa. The in vivo situation, however, consists in a continuous change of maximal congestion and decongestion (nasal cycle) which could not be simulated with the available models. The anatomy of the nasal valve and the nasal septum could not be simulated in the various standard situations. Also in this context, changes of the physical space lead to changes of the irrigation effect. This seems to be an appropriate application for computer simulated analysis. Generally, irrigation systems that build up pressure seem to be more suitable, also with regard to constrictions in the anterior part of the nose because an increased pressure may compensate the declining pressure behind the constriction. In order to refine the pressure measurements, a barometer should be used allowing a more differentiated scaling for lower pressures between 0 and 10 mbar. The pressure values achieved during compression seemed to be less relevant.

Conclusion Nasal irrigations are often recommended for multiple diseases of the nose and the paranasal sinuses and so they have a high practical relevance. This comparative

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investigation is the first to evaluate physical parameters and material characteristics of nasal douches. For irrigation of the whole nasal cavity and paranasal sinuses, compressible douching systems are recommended which have a minimum output pressure of 120 mbar, a good connection of the outlet to the nostril with a possible insertion into the nasal vestibule and an irrigation stream which is directed upwards (45). The material should be transparent, easy to clean and disinfect and should not contain harmful elements. Conflict of interest The authors declare that they do not have a financial relationship with any organization that sponsored the research.

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