Recruiting
Early Phase 1

HVSI vs. LVSI

Sponsor:

University of British Columbia

Code:

NCT02636959

Conditions

Rhinosinusitis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

saline irrigation

Study Details

Brief summary:

Chronic sinusitis (CRS) is a common inflammatory sinus condition among Canadians. Saline irrigation is an effective therapy used in the management of CRS and is a commonly prescribed treatment in preoperative surgery for people with this condition. Recently, a study performed by a Toronto group in Canada tried to show if there is any significant improvement between using high versus low volume saline irrigation to treat CRS. Despite finding a trend, the number of people with CRS used in this pilot study was not large enough to conclusively declare any difference between the two treatment groups.

PURPOSE: The purpose of this study is to determine if there is a clinical benefit of high volume saline nasal irrigation (HVSI) over low volume saline irrigation (LVSI) in the postoperative period in patients with chronic Rhinosinusitis (CRS). This study is part of a multicenter collaborative project initiated by Macdonald et al. (20). A sample size of 176 participants (88 in each condition) is required to achieve data significance. To achieve this, our role is to collect data (plus those of four other Canadian rhinology research centres) from 20 patients and add our findings to theirs to establish an acceptable and significant result. This information would help otolaryngologists, family physicians, and other health care professionals recommend the best post-operative SNI (saline nasal irrigation) device for their patients with CRS.

Conditions

Rhinosinusitis

Study ID

NCT02636959

Start date

Dec, 2015

Status verified date

May, 2016

Completion date

Jun, 2017

Anticipated

Primary completion date

Mar, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Documented diagnosis of unilateral or bilateral CRS
  • Documented failed medical treatment of CRS
  • 18 to 65 years of age
  • Planned ESS for the treatment of CRS
  • Able to read and understand English

Exclusion Criteria:

  • Pregnant
  • Cystic Fibrosis
  • Diagnosed immotile cilia syndrome
  • Diagnosed immunodeficiency syndrome
  • Diagnosed fungal sinusitis
  • Sinonasal tumours or obstructive lesions

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: high volume saline irrigation (HVSI)

High volume nasal spray, NeilMed® Sinus Rinse, is a high saline nasal rinse that is a safe, nonpharmacologic treatment. Randomized participants will be asked to use the rinse for one month (twice daily) by following the manufacturer's guidelines and use of the squeeze bottle provided. Preoperative and one month Postoperative sinus surgery, the participants will complete subjective questionnaires and at one-month after surgery, endoscopic sinonasal photos will be taken. These data will be used to assess the quality of postoperative improvements after treatment.

active comparator: low volume saline irrigation (LVSI)

Low volume nasal spray, Salinex Rinse, is a low saline nasal rinse that is a safe, nonpharmacologic treatment. Randomized participants will be asked to use the rinse for one month (twice daily) by following the manufacturer's guidelines and use of the squeeze bottle provided. Preoperative and one month Postoperative sinus surgery, the participants will complete subjective questionnaires and at one-month after surgery, endoscopic sinonasal photos will be taken. These data will be used to assess the quality of postoperative improvements after treatment.

Interventions

saline irrigation

HVSI (NeilMed® Sinus Rinse™) versus LVSI (Salinex®) in the early post-operative management in patients with chronic rhinosinusitis. Both are a saline rinse spray.

Primary outcome measure

  • Change of preoperative from postoperative CT endoscopic photo scans used to evaluate different saline irrigation treatment volumes in patients with chronic rhinosinusitis. [ Time Frame: 30 min at enrollment and 20 minutes at 1-month postoperative follow-up ]
  • Change of preoperative from postoperative sinus surgery regarding quality of life based on SNOT-22 questionnaire. [ Time Frame: 15 min at enrollment and 10 minutes at 1-month postoperative follow-up ]
  • Change of preoperative from postoperative sinus surgery regarding quality of life based on the Nasal and Sinus Symptoms Score questionnaire. [ Time Frame: 15 min at enrollment and 10 minutes at 1-month postoperative follow-up ]

Central Contacts and Locations

Central contacts

Javier Ospina, MD

604-715-8276jospinadiaz@gmail.com

Elizabeth Hui, PhD

604-875-4111elizabeth.hui@ubc.ca

Locations

Vancouver General Hospital/Otolaryngology Clinic

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Arif Janjua, MD

604-875-8296dr.janjua.office@gmail.com

Javier Ospina, MD

604-715-8276jospinadiaz@gmail.com

More Information

Sponsor

University of British Columbia

Last update posted

May 20, 2016

Last verified

May, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2016-05-20.