15-Degree Tilt, Head Up, Feet Down Body Position for Sinus Surgery Patients

NCT01442740 | Completed

• 1 other identifier: RTP-2011
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinusitis

Keywords

Functional Endoscopic Sinus Surgery; Reverse Trendelenburg Position

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Intra-operative vital signs

  Every 15 minutes for the duration of surgery.

Study Arms (2)

15-degree Reverse Trendelenburg Position

EXPERIMENTAL

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

0-degree Supine Position

NO INTERVENTION

Patients will be placed on the operating table in the standard, 0-degree supine position.

Interventions

Reverse Trendelenburg Position PROCEDURE

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.

Also known as: RTP

15-degree Reverse Trendelenburg Position

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who will undergo primary or revision functional endoscopic sinus surgery (FESS)
• Patients with CRS with or without nasal polyposis

You may not qualify if:

• Patients with a history of coagulation disorders
• Patients with severe or uncontrolled cases of hypertension and cardiovascular disease
• Patients undergoing sinonasal tumor resection

Sponsors & Collaborators

• St. Paul's Hospital, Canada: lead

Study Sites (1)

E.N.T. Clinic, St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (8)

• Rosenfeld RM. Clinical practice guideline on adult sinusitis. Otolaryngol Head Neck Surg. 2007 Sep;137(3):365-77. doi: 10.1016/j.otohns.2007.07.021.

  PMID: 17765760 BACKGROUND

• 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.

  PMID: 21490181 BACKGROUND

• 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. doi: 10.1016/j.otohns.2006.10.028.

  PMID: 17418259 BACKGROUND

• 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.

  PMID: 20869570 BACKGROUND

• 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.

  PMID: 16270608 BACKGROUND

• 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. doi: 10.1097/00005537-200406000-00016.

  PMID: 15179210 BACKGROUND

• 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. doi: 10.1016/0002-9610(57)90626-8. No abstract available.

  PMID: 13424879 BACKGROUND

• Rolighed Larsen JK, Haure P, Cold GE. Reverse Trendelenburg position reduces intracranial pressure during craniotomy. J Neurosurg Anesthesiol. 2002 Jan;14(1):16-21. doi: 10.1097/00008506-200201000-00004.

  PMID: 11773818 BACKGROUND

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Amin R Javer, MD, FRCSC, FARS

  St. Paul's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: September 28, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 30, 2013

Record last verified: 2013-08

Locations

CA (1)