Portuguese Version

Year:  2004  Vol. 70   Ed. 3 - (1º)

Artigo Original

Pages: 295 to 299

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Effect of lubricants on the integrity of the Foley catheter and their implications in nasal packing for epistaxis

Author(s): Fernando P. Gaspar-Sobrinho 1,
Antônio C. Esperidião 2,
Hélio A. Lessa 3

Keywords: Foley catheter, paraffin, lubricant, epistaxis

Abstract:
Nasal packing for epistaxis is usually carried out using lubricated gauze and a Foley catheter. Lubricants such as Vaseline or paraffin can dissolve the Foley balloon of latex; however, they are excipients of various ointments and creams. Aim: To evaluate the effect of potential lubricants on the Foley catheter. Study Design: Experimental. Material and Method: Balloons from eighty Foley catheters were distributed into groups of equal size and kept under traction in contact with one of eight different products: two ointments, three creams, one gel, Vaseline and dry gauze. The balloons were inspected once every 24 hours for five days. The lubricants were tested regarding hydrosolubility. Results: Twenty balloons ruptured, all of them in the Vaseline group or in the group of one of the ointments. The products that did not damage the latex balloon were soluble in water despite the petrolatum excipient. Discussion: It is conjectured that hydrophobic lubricant contained petrolatum used to lubricate the gauze of nasal packing may damage the Foley catheter when in close contact with it. Conclusion: The creams tested in this study, as well as the Furacin® ointment, may be suggested as suitable for use as lubricants of the gauze used in the anterior nasal packing associated with the Foley balloon as they cause no deterioration to the nasal balloon. Our results suggest that hydro soluble creams, ointments and gels preserve to Foley catheter integrity although contained petroleum derivatives in excipient.

Introduction

Nasal packing is frequently conducted for treatment of refractory epistaxis, and there are different materials and techniques to manufacture it. Foley catheter is a latex instrument that has an inflating balloon adapted for posterior nasal packing. It is normally lubricated before it is introduced in the nasal fossa 1 and it is frequently used together with anterior nasal packing made with lubricated gauze, which is in close contact with the junction. Finally, it is maintained in position by moderate traction through external fixation 2, for 3 to 5 days 3, 4.

Therefore, upon preparing anterior-posterior nasal packing with gauze and Foley catheter, the contact of the balloon with lubricants can occur in two situations: 1. upon lubricating the catheter in order to help the insertion into the nasal fossa; and 2. once the balloon is inflated in the nasopharynx it is in contact with lubricated gauze of the anterior nasal packing.

Manufacturers and researchers have forbidden the use of Vaseline and other oil by-products in lubricating Foley catheter owing to the risk of balloon rupture, since these compounds may dissolve latex 5-7. For this reason, anesthetic gels in general are advocated as lubricants to the instrument 1.

Even though there is consensus about the lubrication of Foley catheter, clinical or experimental observations have reached contradicting conclusions in what refers to the use of Vaseline or paraffin as lubricants in anterior nasal packing associated with Foley balloon.

Therefore, Vaseline, an oil by-product that is also present in ointments, is frequently reported in the literature, including by textbooks 8, as the gauze lubricant to be used in anterior nasal packing 3. To Wurman et al.9, Vaseline gauze is the most commonly used material in anterior nasal packing for epistaxis.

As general principle, the lubricant of choice for nasal packing should be innocuous to patients and chemical structure of the catheter. But the choice has been made on empirical basis and differs from one healthcare center to the other. Considering that the excipient of lotions and ointments contain Vaseline and/or paraffin, it is important to know the risk of damage to Foley catheter by commercially available compounds.

In order to assess the effects of potential commercially available lubricants over integrity of Foley catheter, the present study proposed to simulate in vitro the contact of lubricated gauze with the balloon of Foley catheter under moderate traction, as supposedly happens in vivo by contact in the nose.

Material and Method

Seventy Foley catheter Rüsch® 14 French (Fr), with recommended volumetric capability of 30ml, inflated with 10ml of distilled water, using a syringe of 20ml BD Plastipak®, were distributed in 7 groups of 10 catheters and submitted, respectively, to contact with one of the following products: solid Vaseline, ointment A (Iruxol®) and B (Furacin®), lotions C (Bactroneo®), D (Verutex®) and E (Garamicina®), and gel F (KY-Gel®). Other 10 catheters under identical conditions were tested with dry gauze, that is, without contact with lubricants. The materials used belonged to the same batch, where within the expiration term and the preservation conditions recommended by the manufacturers.

The catheters were studied under traction in order to simulate the procedures executed in clinical practice 7 (Figure 1). To that end, we used two acrylic plates with 55 cm of length by 30cm of width, thickness of 1.8cm. Each plate presented 45 circular perforations with 0.8cm diameter for transfixation by the main tube of Foley catheter.

The traction was made by a weight fixed to the main tube of each catheter. The mass used for traction in the conditions described above was previously estimated in 454 grams 7 (originally one pound) and maintained in suspension by impacting Foley balloon on the acrylic plate. The weights were calculated with digital precision scale V6000 Acculab®.

Between the plate and the balloon, we placed a circular gauze tape with 5cm length and 0.9cm width, dry and homogenously lubricated, as in the tested group, so as to maintain the contact with the balloon surface.

The catheters remained in test for 5 days, at room temperature and without sun exposure. To assure its integrity, the mass in each Foley catheter was measures at the beginning and end of treatment. We inspected the device every 24 hours, and the occurrence of rupture was recorded systematically, and frequency of any event was compared between the different groups.

Equal portions of each tested lubricant were applied over the smooth surface acrylic plate and separately submitted to rising with running water associated with digital friction, in order to assess the level of water solubility of the products.

Table 1 - Type of formulation, composition, water solubility and effect over integrity of Foley catheter of tested lubricants.

(1) As provided on the product package
(2) Paraffin and/or Vaseline
(3) As provided by the package insert of the product.

Results

Among the 80 Foley catheter tested, twenty had rupture at the end of day 5, being the ones exposed to ointment A (Iruxol®) and Vaseline (Figure 2). Within the first 96 hours, 10 (100%) and 9 (90%) of the tested balloons with Vaseline and ointment A, respectively, were ruptured (Figure 3). The ruptures were preceded by macroscopically visible erosions on the surface of some balloons. In the remaining Foley catheters, no macroscopic damage was observed, and the measured mass before and after the experiment was maintained unaltered.

Contrarily to ointment A (Iruxol®) and Vaseline, ointment B (Furacin®), lotions and gel were easily removed from the acrylic plate surface by water rinsing associated with digital friction (Table 1). It was confirmed by the presence of homogenous liquid film adhered to the surface of the plate after rinsing of the material, indicating absence of grease particles.

Figure 1 - Picture of the device set to maintain Foley's catheter balloon under moderate traction and in contact with dry or lubricated gauze by different pharmaceutical formulations.



Figure 2 - Picture of the device, 4th day of the experiment, showing that nine and ten Foley catheters had ruptured in the group of ointment A (Iruxol®) and Vaseline (V), respectively. Conversely, over the same plate, the catheters in contact with ointment B (Furacin®) and lotion C (Bactroneo®) were intact.



Graph 1 - Graph that shows the number of Foley catheter exposed to lubricants or dry gauze and the remaining catheters after every 24 hours.

Discussion

The study showed that lubricants in close contact with the balloon of Foley catheter may cause rupture before the recommended period for anterior-posterior nasal packing, which is 3 to 5 days 3, 4. All catheters exposed to Vaseline and ointment A (Iruxol®) were ruptured during the observation period (Figure 2).

Conversely, the experiment showed that lotions, gels and even some ointments can maintain the integrity of Foley catheter during the time period advocated by the literature for nasal packing. We did not observe rupture or macroscopic lesion in balloons exposed to lotions, ointment B (Furacin®) and gel (Figure 2).

Ointments are preparations of semi-solid or paste consistency containing active principles for external use 10, 11. As to the excipient used, it can be ointments, lotions or gels, among others. The ointment has high content of greasy components of animal or mineral origin (for example, Vaseline and mineral oil). The lipid excipient inhibits penetration in the tissue of the incorporated pharmaceutical drug, normally an antibiotic, and limits the therapeutic action to the epidermis and endodermis. Lotions are emulsions whose external stage can be hydrophilic or hydrophobic, and its penetration ranges depending on the composition employed. Gels are normally obtained from polymers with special water adsorption power, being, therefore, hydrophilic 10. They are normally innocuous to rubber, but some hydrophobic compounds, such as Vaseline, are known to promote degeneration of latex.

A water-soluble compound should be easily removed from the surface using water as solvent. In the first experiment, we observed that tested lotions and ointment B were easy to remove from the acrylic plate by rinsing with water associated with digital friction, contrarily to Vaseline and ointment A, which left oily residues (Table 1). Some of the tested lotions presented paraffin and/or Vaseline as excipient suggesting, that only having one oil by-product is less important for the integrity of Foley balloon than general affinity of the lubricant for water. It suggested that rinsing a potential lubricant for contact with Foley catheter may constitute a simple test for the selection of products available in the emergency room.

Individual packages of four different commercial presentations of Foley catheter were analyzed, and only in two of them we found warnings about the risk of damage of latex by oil by-product lubricants.

Stevens12, in 1936, warned about the degeneration of inflating nasal packing made of latex, induced by oil derivate lubricants. In 1977, urologists Pranikoff & Frank5 referred to an epidemics of Foley catheter ruptured by the use of lubricants, then recommended by textbooks in urology, requiring surgical removal of fragments retained by the bladder.

Cook et al.6 observed that lubrication of Foley catheter with Vaseline, previously to introduction in the nasal fossa, was associated with rupture of the catheter balloon and extrusion. Upon talking to the manufacturer, the authors were instructed not to use oil derivate lubricants. They followed the recommendation but maintained and advocated the use of conjugated Foley catheter and Vaseline gauze in anterior nasal packing.

Gonzalez et al.13 reported the use of Terramicin® as anterior gauze lubricant associated with Foley catheter in 235 cases, being that in only 4 (1.7%) there was rupture of balloon for reasons not known by the authors.
McFerran & Edmonds14 tested in vitro, twenty Foley catheters whose balloons were maintained for 5 days recovered in gauze soaked in BIPP (Bismuth Iodoform Paraffin Paste). As a result, they found 8 (40%) balloons ruptured, and the remaining ones presented superficial damage.

Hartley & Axon15 experimentally studied 30 Foley catheters in contact with gauze soaked in BIPP and 15 paraffin catheters. During 80 hours, they did not observe rupture of balloon, even though they presented superficial erosions. Finally, they advocated the use of gauze with BIPP or paraffin stating that the damage was limited and not capable of promoting rupture of balloons in practice. According to some authors, the obtained results confirmed their personal experience.

Ong & Odutoye7 introduced the traction model over Foley catheter. They studied 24 Foley catheter of 12Fr, 14Fr and 16Fr, whose balloons were under traction and supported over Vaseline gauze. They observed that all balloons were ruptured after 72 hours.

As to use of oil derivates in gauze associated with Foley catheter, our results were similar to the ones by McFerran & Edmonds14 and Ong & Odutoye7, but they were against the conclusion by Hartley & Axon15. Differently from Cook et al.6 and Kantu & Turk8, we do not recommend the use of Vaseline gauze as anterior nasal packing conjugated with Foley catheter with balloon, based on the experimental results of the present study, which agree with the personal experience of the main author.

In treating epistaxis, rupture of the balloon in Foley catheter can result in impairment of hemostatic control, release of liquid and fragments of latex, which acts as foreign body 16, in addition to posterior displacement of nasal packing. Even though they are made of latex, glove finger or condom packings reduce the contact of Vaseline gauze with the posterior balloon, in addition to minimizing the trauma to pituitary mucosa.

It is known that nasal packing can cause secondary rhinosinusitis and the rare syndrome of toxic shock. The latter does not respond to systemic antibiotic therapy because the microorganism is found in the nasal packing 17. Moreover, bacterial staphylokinase and streptokinase have fibrinolytic action, being therefore, adverse to hemostasis 18. Thus, the presence of antibiotics in the nasal packing lubricant for topical effect makes it interesting to use many commercially available ointments and lotions.

The Vaseline used in postoperative nasal packing has been associated with parafinoma 19. It is a foreign body tissue reaction to macromolecules of Vaseline and there are no human enzymes capable of degrading them, so they can manifest clinically as benign tumor.

We emphasize that the commercial specifications of lubricants used in this study were chosen as prototypes of pharmaceutical preparations. Recommend them for clinical use is beyond the scope of the present study. It is explained by the fact that the lubricant should be positive to the patient with epistaxis and innocuous to Foley catheter. However, only the latter was studied. Other experimental studies with larger samples addressing instruments and lubricants for nasal packing should be conducted based on the experience of different services of Otorhinolaryngology.

Conclusion

Considering only the innocuous aspect of Foley catheter, our results suggested that the lotions tested and ointment Furacin® could be indicated for lubrication of gauze associated with Foley balloon in anterior-posterior nasal packing for the treatment of epistaxis. The tested gel, even though it preserved the latex balloon, has not been advocated for this purpose. Our results suggested that water-soluble lotions, ointments and gels preserve the integrity of Foley catheter, even though they contain oil-derivates in their excipients.

References

1. Monem AS, Mann G, Suortamo SH. A method of safely securing Foley's catheter in the management of posterior epistaxis with prevention of alar cartilage necrosis. Auris Nasus Larynx 2000; 27: 357-8.
2. Gaspar-Sobrinho FP, Lessa HA. Fixação da sonda de Foley no tratamento da epistaxe posterior e prevenção de lesões à asa do nariz. Arq Otorrinolaringol 2003; 7: 272-6.
3. Cannon CR. Effective treatment protocol for posterior epistaxis: a 10-year experience. Otolaryngol Head Neck Surg 1993; 109: 722-5.
4. Randall DA. The nose and sinuses. In: Lee KJ. Essential Otolaryngology. 7. ed., Norwalk, Appleton & Lange: 1999; 747-90.
5. Pranikoff K, Frank IN. Foley balloon rupture caused by petrolatum ointment. Urology 1977; 9: 656.
6. Cook PR, Renner G, Williams F. A comparison of nasal balloons and posterior gauze packs for posterior epistaxis. J Laryngol Otol 1985; 64: 78-82.
7. Ong CC, Odutoye T. An observation of the effects of paraffin paste on nasal epistaxis balloons. Acta Oto-rhino-laryngologica Belg 1996; 50: 171-5.
8. Kantu M, Turk JB. Epistaxis. In: Lucent FE, Har-El G. Essentials of Otolaryngology. 4. ed., Philadelphia, Lippincot-Willians & Wilkins: 1999; 167-71.
9. Wurman LH, Sack JG, Flannery JV, Lipsman RA. The management of epistaxis. Am J Otolaryngol 1992; 13: 193-209.
10. Ansel HC, Popovich NG, Allen Jr LV. Formas farmacêuticas: considerações biofarmacêuticas. In: Farmacotécnica. 6. ed., São Paulo, Premier: 2000; 96-7.
11. Lund W. Topical semi-solids. In: The Pharmaceutical Codex. 12. ed., London, The Pharmaceutical Press: 1994; 134-5.
12. Stevens RW. Improved intranasal packing: a rubber pneumatic pack. Arch Otolaryngology 1936; 23: 232-5.
13. Gonzalez A, Zabalza E, Sola M, Ortiz M, Moneo M. Tratamiento de epistaxis posteriores con sonda de Foley. An Otorrinolaringol Ibero Am 1989; 5: 527-42.
14. McFerran DJ, Edmonds SE. The use of balloon catheters in treatment of epistaxis. J Laryngol Otol 1993; 107: 197-200.
15. Hartley C, Axon PR. The Foley catheter in epistaxis management - a scientific appraisal. J Laryngol Otol 1994; 108: 399-402.
16. Chrisp JM, Nasey JN. Foley catheter balloon puncture and the risk of free fragment formation. Br J Urology 1990; 66: 500-2.
17. Barbour SD, Shlaes DM, Guertin SR. Toxic-shock syndrome associated with nasal packing: analogy to tampon-associated illness. Pediatrics 1984; 73: 163-5.
18. Quinn FB. Epistaxis pearls from the internet. Grand Rounds Presentation UTMB. Available on: . Accessed on June 28, 2003.
19. Keefe MA, Bloom DC, Keefe K, Killian PJ. Orbital parafinoma as a complication of endoscopic sinus surgery. Otolaryngol Head Neck Surg 2003; 126: 575-7.

(1) Master studies under course, Post-graduation in Medicine and Health, Medical School, Federal University of Bahia. Physician, ENT Emergency, Hospital Geral do Estado.
(2) Joint Professor, Ph.D., Department of General Physics, Institute of Physics, Federal University of Bahia.
(3) Joint Professor, Ph.D., Department of Surgery, Medical School, Federal University of Bahia; Head of the Service of Otorhinolaryngology, Hospital Universitário Prof. Edgard Santos.

Study conducted at the Service of Otorhinolaryngology, Hospital Universitário Prof. Edgard Santos, Medical School, Federal University of Bahia, Laboratory of Projects and Models, Department of General Physics, Institute of Physics, Federal University of Bahia.
Address correspondence to: Fernando P. G. Sobrinho, Cd. Rec. dos Pássaros, R3, B29-A, Ap.301, CEP.: 41150-050 - Salvador-Ba. Tel (55 71) 257-0226 E-mail:fpgs@ufba.br/fpgsobrinho@bol.com.br.

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