15-Degree Reverse Trendelenburg Position for FESS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 64
- Locations
- 2
- Primary Endpoint
- Boezaart intra-operative surgical field scale
Study Overview
Brief Summary
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.
Detailed Description
Our objective is to determine whether 15-degree RTP during FESS will influence intra-operative blood loss and surgical field scores when compared to patients in a supine position.
Our hypothesis is that the 15-degree RTP position is not inferior to the supine position in reducing intra-operative blood loss and improving surgical field view during FESS.
Specific Aims
Aim 1: To determine the effect of 15-degree RTP on total blood loss, time of surgery and endoscopic surgical view, when compared with patients in the supine position, during FESS.
Participants will have their sinus cavities assessed by rigid endoscopy during surgery. The Boezaart scaling system will be used as our primary endoscopic surgical field measure. Total Blood Loss (TBL), Mean Arterial Pressure (MAP), pulse rate and Time of Surgery (TOS) will be recorded intra-operatively by the anesthesiologist and supporting nurse staff. The results of this experiment will determine whether utilizing the 15-degree RTP is effective to reduce blood loss during ESS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who will undergo primary or revision functional endoscopic sinus surgery (FESS)
- •Patients with CRS with or without nasal polyposis
Exclusion Criteria
- •Patients with a history of coagulation disorders
- •Patients with severe or uncontrolled cases of hypertension and cardiovascular disease
- •Patients undergoing sinonasal tumor resection
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Intra-operative vital signs(Every 15 minutes for the duration of surgery.)
Investigators
Amin Javer
Principal Investigator
St. Paul's Hospital, Canada