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Type and Frequency of Nasal Irrigation in Rhinosinusitis Patients

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ClinicalTrials.gov Identifier: NCT04213508
Recruitment Status : Not yet recruiting
First Posted : December 30, 2019
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Dammam University

Tracking Information
First Submitted Date  ICMJE December 7, 2019
First Posted Date  ICMJE December 30, 2019
Last Update Posted Date January 22, 2020
Estimated Study Start Date  ICMJE February 1, 2020
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 1, 2020)
  • Change in Sino-Nasal Outcome Test 22 . [ Time Frame: Change from baseline of Sino-Nasal Outcome Test 22 (SNOT-22) at 1 month ]
    The Sino-Nasal Outcome Test (SNOT-22) is a validated chronic rhinosinusitis -specific outcome measure consisting of 22 items that captures sinus-specific and general health-related impact of the disease process. To answer the instrument, patients suggest their level of affection in each domain and identify the most 5 important items. Each item quantifies symptoms severity from 0 (no problem) to 5 (worst symptom). The sum of each item results in a maximum score of 110 while the minimum is 0 . High score indicates poor outcome. Arabic version of a validated and reliable SNOT-22 will utilize in this study. We will measure the change of SNOT-22 from our baseline after follow up in 1 month
  • Change in Peri-Operative Sinus Endoscopy Score [ Time Frame: Change from baseline of Peri-Operative Sinus Endoscopy (POSE) at 1 month ]
    Peri-Operative Sinus Endoscopy Score (POSE) is objective endoscopic scoring system was utilized to assess the surgical outcomes in the sinonasal cavities through the evaluation of the middle turbinate, middle meatal antrostomy,ethmoid cavity, and secondary sinuses.The sum of maxiumum score is 20 while the minimum is 0 . High score indicates poor result . Th We will measure the change of POSE from our baseline after follow up in 1 month
Original Primary Outcome Measures  ICMJE
 (submitted: December 26, 2019)
  • Change in Sino-Nasal Outcome Test (SNOT-22). [ Time Frame: Change from baseline of SNOT-22 at 1 month ]
    The SNOT-22 is a validated chronic rhinosinusitis -specific outcome measure consisting of 22 items that captures sinus-specific and general health-related impact of the disease process. To answer the instrument, patients suggest their level of affection in each domain and identify the most 5 important items. Arabic version of a validated and reliable SNOT-22 will utilize in this study. We will measure the change of SNOT-22 from our baseline after follow up in 1 month
  • Change in Peri-Operative Sinus Endoscopy Score (POSE) [ Time Frame: Change from baseline of POSE at 1 month ]
    This objective endoscopic scoring system was utilized to assess the surgical outcomes in the sinonasal cavities through the evaluation of the middle turbinate, middle meatal antrostomy,ethmoid cavity, and secondary sinuses. We will measure the change of POSE from our baseline after follow up in 1 month
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Type and Frequency of Nasal Irrigation in Rhinosinusitis Patients
Official Title  ICMJE Isotonic vs Hypertonic Nasal Irrigation and Frequency of Irrigation Per Day in Rhinosinusitis Patients
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 .
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double Blind Study ( Both Participants and Investigator are masked ).
Primary Purpose: Supportive Care
Condition  ICMJE
  • Otorhinolaryngologic Diseases
  • Rhinosinusitis
Intervention  ICMJE
  • Drug: Isotonic Saline ( 0.9% Sodium Chloride Saline)
    0.9% Sodium Chloride (NaCl) saline will be used as nasal irrigation for two groups. (first groups 2 times per day and second group 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 .
  • Drug: Hypertonic Saline ( 3% Sodium Chloride Saline)
    3% Sodium Chloride (NaCl) saline will be used as nasal irrigation for two groups. (first groups 2 times per day and second group 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 200 ml of 3% Sodium Chloride (NaCl) saline will be used daily for 1 month .
Study Arms  ICMJE
  • Active Comparator: Isotonic saline with frequency of 2 times per day
    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 .
    Intervention: Drug: Isotonic Saline ( 0.9% Sodium Chloride Saline)
  • Active Comparator: Hypertonic saline with frequency of 2 times per day
    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 .
    Intervention: Drug: Hypertonic Saline ( 3% Sodium Chloride Saline)
  • Active Comparator: Isotonic saline with frequency of 5 times per day
    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 .
    Intervention: Drug: Isotonic Saline ( 0.9% Sodium Chloride Saline)
  • Active Comparator: Hypertonic saline with frequency of 5 times per day
    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 .
    Intervention: Drug: Hypertonic Saline ( 3% Sodium Chloride Saline)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 26, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Mohammad H Albar, MD 00966506641110 malbar@iau.edu.sa
Contact: Ahmed A Alrahim, MD 00966555805616 dr.ahmed5616@gmail.com
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04213508
Other Study ID Numbers  ICMJE IRB-2019-01-262
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Dammam University
Study Sponsor  ICMJE Dammam University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohammad H Albar, MD Imam Abdulrahman Bin Faisal University
PRS Account Dammam University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP