15-Degree Tilt, Head Up, Feet Down Body Position for Sinus Surgery Patients (RTP)
Functional Endoscopic Sinus Surgery (FESS) is normally performed in our centre in a 0-degree supine position, with the patient laying flat. This study will be investigating whether changing patients to a 15-degree head up, feet down position will improve field of view and reduce blood loss during surgery. The 15-degree head up, feet down position has been used in other circumstances, such as brain surgery and for severely obese patients where airways can be blocked due to lying flat. Every 15 minutes, blood pressure, heart rate and field of view according to the Boezaart nasal scope scaling system will be recorded.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||15-Degree Reverse Trendelenburg Position for FESS|
- Boezaart intra-operative surgical field scale [ Time Frame: Every 15 minutes for the duration of the 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
- Intra-operative vital signs [ Time Frame: Every 15 minutes for the duration of surgery. ] [ Designated as safety issue: No ]The Principal Investigator or one of his designates will record mean arterial pressure, pulse rate and endoscopic surgical field score (5 point system describing clarity of surgical field of view) every 15 minutes from the start of surgery.
|Study Start Date:||October 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Experimental: 15-degree Reverse Trendelenburg Position
Patients will be placed on the operating table in a position where the lower extremities are leveled lower than the head and neck. The angle of incline will be set at 15 degrees from the horizontal.
Procedure: Reverse Trendelenburg Position
Patients will be placed on the operating table in a head up, feet down, tilt position (15 degree tilt to the horizontal). This is in contrast to the standard of care, 0-degree supine position.
Other Name: RTP
No Intervention: 0-degree Supine Position
Patients will be placed on the operating table in the standard, 0-degree supine position.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01442740
|Canada, British Columbia|
|E.N.T. Clinic, St. Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Principal Investigator:||Amin R Javer, MD, FRCSC, FARS||St. Paul's Hospital|