15-Degree Tilt, Head Up, Feet Down Body Position for Sinus Surgery Patients (RTP)
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|ClinicalTrials.gov Identifier: NCT01442740|
Recruitment Status : Completed
First Posted : September 28, 2011
Last Update Posted : August 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Sinusitis||Procedure: Reverse Trendelenburg Position||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||15-Degree Reverse Trendelenburg Position for FESS|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||May 2012|
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.
- Boezaart intra-operative surgical field scale [ Time Frame: Every 15 minutes for the duration of the 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
- Intra-operative vital signs [ Time Frame: Every 15 minutes for the duration of surgery. ]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.
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 ClinicalTrials.gov identifier (NCT number): 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|