COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Hot Saline Irrigation Study (HSI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01717274
Recruitment Status : Completed
First Posted : October 30, 2012
Last Update Posted : April 14, 2016
Information provided by (Responsible Party):
Amin Javer, St. Paul's Hospital, Canada

Brief Summary:

Many methods have been used to reduce bleeding during sinus surgery (FESS) in order to allow for the best surgical view and to reduce risk while in surgery.

Warm irrigation fluid is believed to accelerate the clotting mechanism in the human body. The investigators would like to determine if hot saline irrigation (HSI) compared to room temperature saline irrigation (RTSI) can control bleeding during FESS.

The hypothesis is that HSI is more effective than RTSI in reducing intraoperative bleeding during FESS.

Condition or disease Intervention/treatment Phase
Sinusitis Procedure: Hot saline irrigation Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Hot Saline Irrigation vs Room Temperature Saline Irrigation in the Control of Intraoperative Bleeding During Functional Endoscopic Sinus Surgery (FESS)
Study Start Date : November 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Sinusitis

Arm Intervention/treatment
Experimental: Hot saline irrigation
Hot saline is prepared by first placing 2 litres of sterile normal saline (0.9%) into a basin (IntraTemp Therma BasinTM) that is wrapped in a sterile disposable drape (IntraTemp Therma Basin DrapeTM). The basin is then placed in a medical grade warmer (IntraTemp Fluid Warming SystemTM). The warmer is set to heat the saline up to a temperature of 50 degrees Celsius. An external digital thermometer is placed in the saline at all times to ensure that the temperature is between 45-50 degrees.
Procedure: Hot saline irrigation
The surgical field is flushed with 20 cc of hot saline (45-50 degrees Celsius) at five minutes intervals. This is in contrast to the standard of care, room temperature (20-25 degrees Celsius) saline irrigation.
Other Name: HSI

No Intervention: Room temperature saline irrigation
Room temperature saline is prepared in the same manner as the experimental arm except that the warmer is switched off and the temperature of the saline in the basin is left to equilibrate to the temperature of the operating room.

Primary Outcome Measures :
  1. The Boezaart and van der Merwe intraoperative surgical field scale [ Time Frame: Every 15 minutes for the duration of surgery.. ]
    The Boezaart intra-operative surgical field scale will be used to grade the level of bleeding during surgery. This 0 to 5-point scale will be used to outline the amount of suction required to rid the area of blood disrupting vision. A score of 0 is given for an area with no bleeding, 1 for slight bleeding with no suction required, 2 for slight bleeding requiring suction, 3 for moderate bleeding which improves for several seconds once suction has occurred, 4 for moderate bleeding which restarts directly after suctioning and 5 for severe bleeding which occurs faster then can be removed

Secondary Outcome Measures :
  1. Total Estimated Blood Loss [ Time Frame: Duration of surgery ]
    Total blood loss will be recorded over the duration of surgery.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with American Society of Anesthesiologist (ASA) classification <2
  • Patients with chronic or recurrent sinusitis (as defined by the American Academy of Otolaryngology) with or without nasal polyposis refractory to medical treatment

Exclusion Criteria:

  • Patients with a history of coagulation disorders
  • Patients with severe ischemic heart disease (IHD), pulmonary and renal disease
  • Patients with tumours or vascular anomalies
  • Patients with cystic fibrosis, allergic fungal sinusitis and Wegener's granulomatosis
  • Patients who are unable to speak, read and write English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01717274

Layout table for location information
Canada, British Columbia
E.N.T. Clinic, St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
St. Paul's Hospital, Canada
Layout table for investigator information
Principal Investigator: Amin R Javer, MD, FRCSC, FARS St Pauls Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Amin Javer, Principal Investigator, St. Paul's Hospital, Canada Identifier: NCT01717274    
Other Study ID Numbers: HSI-2012
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Keywords provided by Amin Javer, St. Paul's Hospital, Canada:
Functional Endoscopic Sinus Surgery
Hot water irrigation
Additional relevant MeSH terms:
Layout table for MeSH terms
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases