Type and Frequency of Nasal Irrigation in Rhinosinusitis Patients

Imam Abdulrahman Bin Faisal University

Status and phase: Unknown; Phase 4

Conditions: Rhinosinusitis; Otorhinolaryngologic Diseases

Treatments: Drug: Isotonic Saline ( 0.9% Sodium Chloride Saline); Drug: Hypertonic Saline ( 3% Sodium Chloride Saline)

Study type: Interventional

Funder types: Other

Identifiers

NCT04213508

IRB-2019-01-262

Details and patient eligibility

About

Rhinosinusitis is a common clinical problem with significant morbidity which alters patients' quality of life that has its effect on 1 out of 7 adults. It has been found that rhinosinusitis accounts for almost 26 million clinics and emergency visits per year in United states .Nasal irrigation is standard management used to treat a variety of sinonasal diseases. Furthermore, nasal irrigation decreases the need of usage other medications in rhinosinusitis .Hence, it is considered safe, inexpensive, and easy to use with no evidence of major adverse effects .Up to our knowledge, there is no clear guideline in which type (isotonic saline vs hypertonic saline) and frequency (times per day) of nasal irrigation are superior and better.

Full description

Nasal irrigation is one of the main treatment of sinonasal diseases. The mechanism of action of nasal irrigation has many physiological aspects such as removing of excess mucus which is a potential medium for bacterial growth and infection, cleaning of antigens and biofilm to decrease inflammatory process, increase mucocilliary function and removing curst and debris from post-surgery to enhance wound healing and mucosalization Hypertonic saline is defined as a solution with more than 0.9% weight per volume of sodium chloride while isotonic saline is defined as a solution that equals to 0.9% weight per volume of sodium chloride. There are controversial studies in the literature on which saline is superior on the other, some prefer hypertonic saline over isotonic saline because it can move water outside the cells, decrease edema of mucosa, increase hydration of sol layer and decrease muco-adhesiveness and improve mucociliary clearance while others found both solution had same efficacy, improved nasal stuffiness and nasal obstruction but patients prefer isotonic saline because it is well tolerated and less burning sensation. Frequency of nasal irrigation per day is poorly studied in the literature with no known recommended times per day. Our aim is to find which type of saline and number of irrigation per day are better and statistically significant .

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age from 18 years of either gender
• Acute and chronic rhinosinusitis

Exclusion criteria

• History of nasal or sinus surgery
• Age less than 18 years of either gender
• diagnosis other than rhinosinusitis

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups

Isotonic saline with frequency of 2 times per day

Active Comparator group

Description:

0.9% Sodium Chloride (NaCl) saline will be used as nasal irrigation for 2 times per day. Each time, amount of 50 ml of saline will be used in each nostril ( 100 ml for both nostrils per time) . So, in total 200 ml of 0.9% Sodium Chloride (NaCl) saline will be used daily for 1 month .

Treatment:

Drug: Isotonic Saline ( 0.9% Sodium Chloride Saline)

Hypertonic saline with frequency of 2 times per day

Active Comparator group

Description:

3% Sodium Chloride (NaCl) saline will be used as nasal irrigation for 2 times per day. Each time, amount of 50 ml of saline will be used in each nostril ( 100 ml for both nostrils per time) . So, in total 200 ml of 3% Sodium Chloride (NaCl) saline will be used daily for 1 month .

Treatment:

Drug: Hypertonic Saline ( 3% Sodium Chloride Saline)

Isotonic saline with frequency of 5 times per day

Active Comparator group

Description:

0.9% Sodium Chloride (NaCl) saline will be used as nasal irrigation for 5 times per day. Each time, amount of 50 ml of saline will be used in each nostril ( 100 ml for both nostrils per time) . So, in total 500 ml of 0.9% Sodium Chloride (NaCl) saline will be used daily for 1 month .

Treatment:

Drug: Isotonic Saline ( 0.9% Sodium Chloride Saline)

Hypertonic saline with frequency of 5 times per day

Active Comparator group

Description:

3% Sodium Chloride (NaCl) saline will be used as nasal irrigation for 5 times per day. Each time, amount of 50 ml of saline will be used in each nostril ( 100 ml for both nostrils per time) . So, in total 500 ml of 3% Sodium Chloride (NaCl) saline will be used daily for 1 month .

Treatment:

Drug: Hypertonic Saline ( 3% Sodium Chloride Saline)