Sinusitis Clinical Trial
— RTPOfficial title:
15-Degree Reverse Trendelenburg Position for FESS
Verified date | August 2013 |
Source | St. Paul's Hospital, Canada |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | May 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Canada | E.N.T. Clinic, St. Paul's Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
St. Paul's Hospital, Canada |
Canada,
Albu S, Gocea A, Mitre I. Preoperative treatment with topical corticoids and bleeding during primary endoscopic sinus surgery. Otolaryngol Head Neck Surg. 2010 Oct;143(4):573-8. doi: 10.1016/j.otohns.2010.06.921. — View Citation
Desrosiers M, Hussain A, Frenkiel S, Kilty S, Marsan J, Witterick I, Wright E. Intranasal corticosteroid use is associated with lower rates of bacterial recovery in chronic rhinosinusitis. Otolaryngol Head Neck Surg. 2007 Apr;136(4):605-9. — View Citation
Meltzer EO, Hamilos DL. Rhinosinusitis diagnosis and management for the clinician: a synopsis of recent consensus guidelines. Mayo Clin Proc. 2011 May;86(5):427-43. doi: 10.4065/mcp.2010.0392. Epub 2011 Apr 13. Review. — View Citation
Nair S, Collins M, Hung P, Rees G, Close D, Wormald PJ. The effect of beta-blocker premedication on the surgical field during endoscopic sinus surgery. Laryngoscope. 2004 Jun;114(6):1042-6. — View Citation
Rolighed Larsen JK, Haure P, Cold GE. Reverse Trendelenburg position reduces intracranial pressure during craniotomy. J Neurosurg Anesthesiol. 2002 Jan;14(1):16-21. — View Citation
Rosenfeld RM. Clinical practice guideline on adult sinusitis. Otolaryngol Head Neck Surg. 2007 Sep;137(3):365-77. Review. — View Citation
SHANE SM, ASHMAN H. The prevention of postoperative shock and postanesthesia hypotension by use of the reverse Trendelenburg position during surgery under light, etherless, general anesthesia. Am J Surg. 1957 Jul;94(1):102-7. — View Citation
Wormald PJ, van Renen G, Perks J, Jones JA, Langton-Hewer CD. The effect of the total intravenous anesthesia compared with inhalational anesthesia on the surgical field during endoscopic sinus surgery. Am J Rhinol. 2005 Sep-Oct;19(5):514-20. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Boezaart intra-operative surgical field scale | 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 | Every 15 minutes for the duration of the surgery | No |
Secondary | Intra-operative vital signs | 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. | Every 15 minutes for the duration of surgery. | No |
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