The HVSI STUDY: High Volume Saline Irrigation in the Post-operative Management of Chronic Rhinosinusitis: A Multicenter Randomized Single-Blind Controlled Trial

Background: Chronic Rhinosinusitis (CRS) is a common inflammatory condition of the upper respiratory tract lasting more than 8 to 12 weeks. Major symptoms include facial congestion/fullness, facial pain/pressure, nasal obstruction/blockage, purulent nasal drainage, and reduction or loss of smell. The diagnosis must include two major symptoms and either endoscopic evidence of polyps, edema or mucopurulent discharge from the middle meatus and/or CT changes in the mucosa of sinuses or osteomeatal complexes.1

CRS has an estimated prevalence of 5% in the Canadian population2, and up to 16% in some adult populations in the United States.3 Sinusitis is associated with a major societal health care burden, costing billions of dollars a year in North America.4,5 The medical treatment of CRS includes topical saline and corticosteroid sprays, systemic steroids and antimicrobials. Specifically, saline nasal irrigation (SNI) is a safe, nonpharmacologic treatment, and an important and efficacious component in the management of CRS.6,7 SNI can vary by concentration (e.g. hypertonic, isotonic, hypotonic) and device (e.g. bulb syringe, nasal mist, squeeze bottle).

The Mayo Clinic recently reviewed major expert consensus guidelines on the medical treatment of CRS.8 Although they recognized an overall paucity of controlled trials for any medical treatment, and a lack of a consensus or algorithm in the treatment of CRS, there is an overall consensus agreement of the use for SNI in this population. In this review, there was no mention of treatment of CRS in postoperative period, and no recommendation of what type of SNI is best.

Few studies examine various SNI formulations in the postoperative period. These were highlighted by Canadian authors in a recent exhaustive review of SNI in sinusitis.9 Three studies, all greater than 15 years old, include formulations that are not currently in popular use, or even available in North America.10-12 These did show that pressurized jets or sprays of seawater were more effective than nasal drops. More recently, Harvey et al. examined how irrigation is delivered and retained in the sinus, using more common devices.13,14 In a cadaveric model, they compared HVSI to LVSI devices and found a greater delivery (p<..02) in the former. To date there are no studies comparing HVSI to LVSI, using subjective patient benefit and objective endoscopic measure outcomes, in the postoperative CRS patient.

One study did examine two different SNI devices in the management of CRS.15 The authors recruited 150 subjects with CRS in the primary care setting, and randomized them to two weeks of SNI with a bulb syringe, SNI with a nasal irrigation pot, and a control group of reflexology massage.15 Hypertonic saline was used in both treatment groups. Subjective questionnaires were administered at baseline and at the end of the study period. Both groups significantly improved, with no significant difference between the two SNI devices. Patients equally preferred the two devices.