Use of Azelastine and Sodium Chloride Spray for Prevention of Sinusitis in ICU Admitted Patients: A Randomized Clinical Trial

Amirebrahim Miroliaei, Ramin Hamidi Farahani, Morteza Taheri, Ebrahim Hazrati

Abstract


Background: Nosocomial sinusitis is a common and less attended complication in patients admitted to intensive care units (ICU). It can cause several problems, such as prolongation of hospitalization, comorbidity, and mortality in patients. The present study aimed to evaluate the effect of azelastine (second‑generation antihistamine) and sodium chloride spray on sinusitis prevention in ICU admitted patients. Methods: In this randomized, open‑label, and parallel clinical trial a total of 126 patients were enrolled (63 patients per arm). Finally, 121 patients (61 patients in the control group and 60 patients in the treatment group) completed the study, and 120 patients entered the final analysis. In the treatment group, during 24 h after the insertion of nasogastric tube azelastine and sodium chloride sprays were administered (one puff from each spray every 12 h) while no intervention was conducted in the control group. Primary and secondary end‑points were evaluated within 10 days of the study period. Results: The incidence of sinusitis and pneumonia (18.3% and 16.6% in the control group compared to 8.3% and 3.3% in the treatment group, respectively) in the treatment group showed a decreasing trend; however, only the difference of pneumonia was statistically significant between groups (P = 0.03). In addition to the clinical pulmonary infection score, nasal and tracheal secretions were significantly improved in the treatment group (P = 0.03, P < 0.001, and P = 0.01, respectively). Conclusions: The findings of the present study offer an inexpensive, low‑risk, and efficacious intervention for the prevention of upper respiratory tract infections in ICU patients.

Keywords


Intensive care unit; histamine H1 antagonists; sinusitis; sodium chloride

Full Text:

PDF

References


Agrafiotis M, Vardakas KZ, Gkegkes ID, Kapaskelis A,

Falagas ME. Ventilator‑associated sinusitis in adults: Systematic

review and meta‑analysis. Respir Med 2012;106:1082‑95.

George DL, Falk PS, Umberto Meduri G, Leeper KV Jr.,

Wunderink RG, Steere EL, et al. Nosocomial sinusitis in patients

in the medical intensive care unit: A prospective epidemiological

study. Clin Infect Dis 1998;27:463‑70.

Stein M, Caplan ES. Nosocomial sinusitis: A unique subset of

sinusitis. Curr Opin Infect Dis 2005;18:147‑50.

Adeyemo AA, Fasunla AJ, Adeosun AA, Abdullahi H.

Rhinosinusitis; A potential hazard of nasogastric tube insertion.

Ann Ib Postgrad Med 2007;5:44‑5.

McCormick J, O’Mara M, Wakefield W, Goldfarb I, Slater H,

Caushaj P. Effect of diagnosis and treatment of sinusitis in

critically ill burn victims. Burns 2003;29:79‑81.

Aggarwal S, Azim A, Baronia A, Kumar R. Evaluation and

management of nosocomial sinusitis in intensive care unit

patients for pyrexia of unknown origin: Case report and review

of literature. Int J Med Biomed Res 2012;1:161‑6.

Camus C, Bellissant E, Sebille V, Perrotin D, Garo B, Legras A,

et al. Prevention of acquired infections in intubated patients with

the combination of two decontamination regimens. Crit Care

Med 2005;33:307‑14.

Pneumatikos I, Konstantonis D, Tsagaris I, Theodorou V,

Vretzakis G, Danielides V, et al. Prevention of nosocomial

maxillary sinusitis in the ICU: The effects of topically applied

alpha‑adrenergic agonists and corticosteroids. Intensive Care

Med 2006;32:532‑7.

Schweickert WD, Gehlbach BK, Pohlman AS, Hall JB, Kress JP Daily interruption of sedative infusions and complications of

critical illness in mechanically ventilated patients. Crit Care Med

;32:1272‑6.

Aebert H, Hunefeld G, Regel G. Paranasal sinusitis and sepsis in

ICU patients with nasotracheal intubation. Intensive Care Med

;15:27‑30.

Hoffmans R, Wagemakers A, van Drunen C, Hellings P,

Fokkens W. Acute and chronic rhinosinusitis and allergic rhinitis

in relation to comorbidity, ethnicity and environment. PloS One

;13:e0192330.

Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F,

et al. EPOS 2012: European position paper on rhinosinusitis and

nasal polyps 2012. A summary for otorhinolaryngologists.

Rhinology. 2012;50:1-12.

Repka‑Ramirez S, Naranch K, Park YJ, Clauw D, Baraniuk JN.

Cytokines in nasal lavage fluids from acute sinusitis, allergic

rhinitis, and chronic fatigue syndrome subjects. Allergy Asthma

Proc 2002;23:185‑90.

Rudack C, Hauser U, Wagenmann M, Bachert C,

Ganzer U. Cytokine pattern in various forms of sinusitis.

Laryngorhinootologie 1998;77:34‑7.

Jiao J, Zhang L. Influence of intranasal drugs on human nasal

mucociliary clearance and ciliary beat frequency. Allergy Asthma

Immunol Res 2019;11:306‑19.

Roca‑Ferrer J, Pujols L, Perez‑Gonzalez M, Alobid I,

Callejas B, Vicens‑Artes S, et al. Superior effect of MP‑AzeFlu

than azelastine or fluticasone propionate alone on reducing

inflammatory markers. Allergy Asthma Clin Immunol

;14:86.

Inanli S, Ozturk O, Korkmaz M, Tutkun A, Batman C. The

effects of topical agents of fluticasone propionate, oxymetazoline,

and 3% and 0.9% sodium chloride solutions on mucociliary

clearance in the therapy of acute bacterial rhinosinusitis in vivo.

Laryngoscope 2002;112:320‑5.

Jurkiewicz D, Rapiejko P. Use of isotonic NaCl solution in

patients with acute rhinosinusitis. Otolaryngol Pol 2011;65:47‑53.

King D, Mitchell B, Williams CP, Spurling GK. Saline nasal

irrigation for acute upper respiratory tract infections. Cochrane

Database Syst Rev 2015:CD006821.

Horak F. Effectiveness of twice daily azelastine nasal spray in

patients with seasonal allergic rhinitis. Ther Clin Risk Manag

;4:1009‑22.

van Zanten AR, Dixon JM, Nipshagen MD, de Bree R,

Girbes AR, Polderman KH. Hospital‑acquired sinusitis is a

common cause of fever of unknown origin in orotracheally

intubated critically ill patients. Crit Care 2005;9:R583‑90.

Abad CL, Pulia MS, Safdar N. Does the nose know? An

update on MRSA decolonization strategies. Curr Infect Dis Rep

;15:455‑64.

Muscedere J, Dodek P, Keenan S, Fowler R, Cook D, Heyland D.

Comprehensive evidence‑based clinical practice guidelines for

ventilator‑associated pneumonia: Diagnosis and treatment. J Crit

Care 2008;23:138‑47.

Aun MV, Ribeiro MR, Costa Garcia CL, Agondi RC, Kalil J,

Giavina‑Bianchi P. Esophageal candidiasis: An adverse effect of

inhaled corticosteroids therapy. J Asthma 2009;46:399‑401.

Babu S, Samuel P. The effect of inhaled steroids on the upper

respiratory tract. J Laryngol Otol 1988;102:592‑4.

John P, Jayasree V. Oropharyngeal candidiasis associated with

use of steroid inhaler in a chronic asthmatic patient: Case report.

Int J Oral Maxillofac Pathol 2013;4:40‑3.

Peter E, Bakri F, Ball DM, Cheney RT, Segal BH. Invasive

pulmonary filamentous fungal infection in a patient receiving

inhaled corticosteroid therapy. Clin Infect Dis 2002;35:e54‑6.

Mohammadi A, Hashemi SM, Abtahi SH, Lajevardi SM,

Kianipour S, Mohammadi R. An investigation on non‑invasive

fungal sinusitis; Molecular identification of etiologic agents.

J Res Med Sci 2017;22:67.

Li G, Cook DJ, Thabane L, Friedrich JO, Crozier TM,

Muscedere J, et al. Risk factors for mortality in patients

admitted to intensive care units with pneumonia. Respir Res

;17:80