An alternative delivery device in nasal irrigation after sinus surgery.
Paranasal sinuses are a group of air containing spaces around the nasal cavity. Mucosal secretion and air conditioning are primary functions of sinuses which is maintained properly by the mucociliary clearance of cilia present in the sinus. Any dysfunction in clearance leads to stasis of mucosal secretion and subsequently causes acute inflammation of the sinuses. The motto of the surgery is to widen the outflow tracts of sinuses.
Functional endoscopic sinus surgery helps to improve sinus ventilation and retain mucociliary clearance. The goal is to maintain the patency and mucociliary clearance after surgery. Nasal douching is one such manoeuvre to fulfil the requirement. Here, the challenge lies in selecting the ideal solution and ideal delivery device. Isotonic saline solution, hypertonic saline,  sea water  and baby shampoo  were tried in various studies. Otolaryngologists observed that saline irrigation after surgery reduced the risk of postoperative mucosal adhesions and enhanced mucosal healing rather than just clearing secretions, debris and crusts.  Universally accepted ideal recipe for douching is salt and sodium bicarbonate in water.
The ideal delivery system should be comfortable to use, easy to clean, and inexpensive. Two varieties of device already exist in the market namely "Negative pressure delivery device" and "Positive pressure delivery device". Solution being drawn into the nose, i.e. sniffed from a bottle or snorted from a cupped hand is called negative pressure delivery. Positive pressure devices actively deliver the solution into the nose, either by gravity (neti pot), hand-generated pressure (bulb syringe, squeeze bottle).
Red rubber bulb syringe is the preferred delivery device in many hospitals all over the world. It satisfies two criteria i.e. comfortable to use and inexpensive but difficult to clean. Cleaning and sterilisation can be done by placing in hot water, which subsequently leads to spoilage of rubber. In case of replacement especially for patients residing in rural areas, he/she needs to commute to nearby hospitals to avail or buy the red rubber bulb. This ultimately leads to discontinuation of nasal douching.
To solve this problem, this paper discusses on an alternative delivery device which uses 20 mL disposable plastic syringe which is comfortable to use, inexpensive and also readily available in all pharmacies. This study had a valid reason of selecting 20 mL syringe because of easy availability which makes it replaceable without difficulty instead of repeated sterilisation.
MATERIALS AND METHODS
Around 120 functional endoscopic sinus surgeries with or without septoplasty for sinusitis and sinonasal polyposis in MAPIMS were carried out between the years 2013-2015. Importance was given to post-operative nasal cleaning to maintain sinus drainage naturally. The routine alkaline douche recipe was not changed, whereas alternative nasal delivery device (i.e.) 20 mL disposable plastic syringe was used instead of routine red rubber bulb. The study group was divided in to two groups by simple random sampling.
The inclusion criteria incorporated the following - (a) Age above 22 years, (b) Endoscopic sinus surgery patients for sinusitis and sinonasal polyposis, (c) Patient's acceptance and consent for study.
The exclusion criteria had the following - (a) Patients who doesn't turn up for regular review (at least once in a month for six months or totally 6 visits in 6 months), (b) Patients who haven't used nasal douching method.
Alkaline douche solution is prepared by adding 2 tablespoons of common salt and 1 tablespoon of baking powder in one litre of lukewarm water. Patients were advised to use half litre of solution three times daily. Douche solution is sucked into the nasal delivery device (red rubber bulb and 20 mL plastic syringe) and the crusts in the post-operative nasal cavity were flushed out by inserting tip of the device in to anterior naris. Patients were cautioned that initial use of nasal douching may cause tickling sensation of the nose and sometimes mild spot bleeding can be noticed in the discharged douche solution.
The findings were made in 120 patients, out of which only 88 of them had satisfied both inclusion and exclusion criteria. 47 were male (53.4%) and 41 were female (46.6%) in the above mentioned 88, in which 32 of them used red rubber bulb and 56 people used plastic syringe. Each of them had regular followup.
Criteria was fixed to achieve good compliance wherein the patients were advised to use delivery devices at least once in a day, even if they had issues like nasal pain, lack of time, etc. Red rubber users showed good compliance than syringe users. As per the questionnaire it was clear that the patients preferred rubber material than the plastic syringe because of its less irritancy. Our results also satisfied statistical significance.
Fifty four percent of syringe users experienced pain during nasal douching compared to thirty one percent RRB users. The pressure exerted in the plastic syringe is along the direction of water flow; syringe moves and hits the nasal mucosa while pressing the piston. This was found to be a reason for more pain in patients using syringe.
The most common undesirable presentations of the study were pain and synechiae formation. The extent of study of using these two techniques is limited by the above mentioned presentations. Based on the post-operative evaluation of the usage of RRB & 20 mL syringe and also considering the limiting factors, it is found out that synechiae formation is the most common complication of both techniques. Its incidence is lesser in RRB users. The study also aimed at an important outcome in post FESS patients which was judged by the persistence of nasal discharge in the corresponding sinus surgery area, during diagnostic nasal endoscopy. Plastic syringe users had little more percentage of nasal discharge than that of rubber bulb users as shown in the Table 4.
Nasal douching with saline is the preferred solution  in post-FESS patients in many institutes all over the world. The only difference is in the way it is delivered like using neti pot, nasal spray, irrigation bottles, etc. In this study, 20 mL plastic syringe (nasal delivery device) was introduced with the regime of nasal irrigation, where the patient has to use it at least once a day.
Wei JL et al  tried once daily irrigation in his study, but they tried in unoperated paediatric patients with chronic rhinosinusitis and their duration of followup was six weeks only. Compliance in their study was about 94% which is greater than best compliance in red rubber users (78%) in our study. Wei JL also documented high tolerance, compliance, and effectiveness of nasal irrigation made it as a first-line treatment for paediatric chronic rhinosinusitis even before considering surgical intervention.
Around 45% of plastic syringe users and 22% of red rubber bulb users in this study discontinued the douching. Mari Egan  also documented significant portion (21%) of pot users and 7% of nasal spray users discontinued treatment in his study. The reasons for non-compliance in this study were nasal pain, irritant plastic material, burning sensation due to saline solution, etc.
Out of 120 patients, only 88 (73.33%) patients had regular followup which is comparatively greater than 51.4% patients in Keerl R  et al study. But their followup period was greater for about 27-36 months compared to the followups that was carried out in our study postoperatively for a period of six months.
Rabago D quoted that acceptance, ease of use, training, cost, and head position may all contribute to the overall effectiveness of nasal delivery devices in nasal irrigation.  Both Brook I and Heatley DG accepted that reusable products has lower cost per irrigation compared with preformed nasal sprays, although there may be more risk of contamination in reusable delivery products. [9,10] The product in this study had low volume (20 mL) compared to rubber bulb which has a capacity to deliver 80 mL and also there is difference in the direction of pressure exertion. Even though the red rubber bulb is 2.5 cm long, it can reach the nasal cavity only up to 1 cm from the external naris which can be done with the plastic syringe itself. Synechiae was present more in the plastic syringe users (39%) than rubber bulb users (22%) especially in between inferior turbinate and nasal septum and approximately 1 cm from external naris. The direction of pressure exertion in syringe was parallel to the direction of water flow which made the syringe to move forward. This was the cause for more synechiae formation and its plastic consistency also caused more pain. The pressure exerted in the red rubber bulb was perpendicular to the direction of water flow and there was no forward movement of tip of rubber bulb during nasal cleaning, which caused comparatively lesser synechiae and its rubber material caused lesser pain.
The above article with detailed study took up plastic syringe s an alternative delivery device for nasal irrigation. Positive aspects of using this device are that the plastic syringes are easily available, easy to use, can be replaced easily, etc., Test and trials were made and the feasibility of using this device resulted only up to 55% because of its evident formation of synechiae and pain.
 Hauptman G, Ryan MW. The effect of saline solutions on nasal patency and mucociliary clearance in rhinosinusitis patients. Otolaryngol Head Neck Surg 2007;137(5):815-21.
 Bonnomet A, Luczka E, Coraux C, et al. Non-diluted seawater enhances nasal ciliary beat frequency and wound repair speed compared to diluted seawater and normal saline. Int Forum Allergy Rhinol 2016;6(10):1062-8.
 Chiu AG, Palmer JN, Woodworth BA, et al. Baby shampoo nasal irrigations for the symptomatic post-functional endoscopic sinus surgery patient. Am J Rhinol 2008;22(1):34-7.
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 Keerl R, Weber R, Muller C, et al. Effectiveness and tolerance of nasal irrigation following paranasal sinus surgery. Laryngorhinootologie 1997;76(3):137-41.
 Wei JL, Sykes KJ, Johnson P, et al. Safety and efficacy of once-daily nasal irrigation for the treatment of pediatric chronic rhinosinusitis. Laryngoscope 2011;121(9):1989-2000.
 Egan M, Hickner J. Saline irrigation spells relief for sinusitis sufferers. J Fam Pract 2009;58(1):29-32.
 Rabago D, Barrett B, Marchand L, et al. Qualitative aspects of nasal irrigation use by patients with chronic sinus disease in a multimethod study. Ann Fam Med 2006;4(4):295-301.
 Brook I. Bacterial contamination of saline nasal spray/drop solution in patients with respiratory tract infection. Am J Infect Control 2002;30(4):246 -7.
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Nagendran Navaneethan (1), Praveen KumarJayaraj (2), Udaya Kumar Muthu Kumar (3), Ramanathan Thirunavukkarasu (4)
(1) Associate Professor, Department of ENT, Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research, Melmaruvathur.
(2) Assistant Professor, Department of ENT, Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research, Melmaruvathur.
(3) Assistant Professor, Department of ENT, Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research, Melmaruvathur.
(4) Professor and HOD, Department of ENT, Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research, Melmaruvathur.
Financial or Other, Competing Interest: None.
Submission 10-01 -2017, Peer Review 19-02-2017,
Acceptance 25-02-2017, Published 06-03-2017.
Nagendran Nananeethan, Associate Professor, Department of ENT, Melmaruvathur Adhiparasakthi Institute of Medical Sciences, Melmaruvathur.
Table 1. Sex Distribution Frequency Percent Female 41 46.6 Male 47 53.4 Total 88 100.0 Table 2. Compliance of Nasal Douching Good Poor Total Red Rubber 25 7 32 % 78% 22% 36% Syringe 31 25 56 % 55% 45% 64% Total 56 32 88 % 64% 36% Chi Square 4.56 * P<0.05 Table 3. Pain during Alkaline Douche in Two Groups Pain No Yes Total Red rubber 22 10 32 % 69% 31% 36% Syringe 26 30 56 % 46% 54% 64% Total 48 40 88 % 55% 45% Chi Square 4.09 * P<0.05 Table 4. Endoscopic Findings in Both Groups Cross Tabulation Endoscopic Findings Total Discharge Normal Synechiae Red Count 6 19 7 32 Treat- Rubber % 19% 59% 22% 36.4% ment Syringe Count 13 21 22 56 % 23% 38% 39% 63.6% Total Count 19 40 29 88 % 100.0% 100.0% 100.0% 100.0 within % DNE Chi square = 4.205, p= 0.122 non-significant
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|Title Annotation:||Original Research Article|
|Author:||Navaneethan, Nagendran; KumarJayaraj, Praveen; Kumar, Udaya Kumar Muthu; Thirunavukkarasu, Ramanatha|
|Publication:||Journal of Evolution of Medical and Dental Sciences|
|Date:||Mar 6, 2017|
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