Hot Saline Irrigation Study (HSI)

This study is currently recruiting participants.
Verified March 2014 by St. Paul's Hospital, Canada
Sponsor:
Information provided by (Responsible Party):
Amin Javer, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01717274
First received: October 26, 2012
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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 Intervention
Sinusitis
Procedure: Hot saline irrigation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by St. Paul's Hospital, Canada:

Primary Outcome Measures:
  • The Boezaart and van der Merwe intraoperative surgical field scale [ Time Frame: Every 15 minutes for the duration of surgery.. ] [ Designated as safety issue: No ]
    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:
  • Total Estimated Blood Loss [ Time Frame: Duration of surgery ] [ Designated as safety issue: No ]
    Total blood loss will be recorded over the duration of surgery.


Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717274

Contacts
Contact: Amin R Javer, MD, FRCSC, FARS (604) 806- 9926 sinussurgeon@shaw.ca

Locations
Canada, British Columbia
E.N.T. Clinic, St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Amin R Javer, MD, FRCSC, FARS    604-806-9926    sinussurgeon@shaw.ca   
Principal Investigator: Amin R Javer, MD, FRCSC, FARS         
Sponsors and Collaborators
St. Paul's Hospital, Canada
Investigators
Principal Investigator: Amin R Javer, MD, FRCSC, FARS St Pauls Hospital
  More Information

Publications:
Responsible Party: Amin Javer, Principal Investigator, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier: NCT01717274     History of Changes
Other Study ID Numbers: HSI-2012
Study First Received: October 26, 2012
Last Updated: March 3, 2014
Health Authority: Canada: Health Canada

Keywords provided by St. Paul's Hospital, Canada:
Functional Endoscopic Sinus Surgery
Hot water irrigation

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014