Clinical trial NCT04213508: Type and Frequency of Nasal Irrigation in Rhinosinusitis Patients
Official title: Isotonic vs Hypertonic Nasal Irrigation and Frequency of Irrigation Per Day in Rhinosinusitis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Otorhinolaryngologic Diseases
Rhinosinusitis
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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 .

Eligibility criteria: 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

Primary outcomes:
measure: Change in Sino-Nasal Outcome Test 22 .
timeFrame: Change from baseline of Sino-Nasal Outcome Test 22 (SNOT-22) at 1 month
measure: Change in Peri-Operative Sinus Endoscopy Score
timeFrame: Change from baseline of Peri-Operative Sinus Endoscopy (POSE) at 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: Imam abdulrahman bin faisal university
state: Eastern Province
Study officials:
affiliation: Imam Abdulrahman Bin Faisal University
name: Mohammad H Albar, MD
role: PRINCIPAL_INVESTIGATOR
References: