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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amin Javer, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01442740
First received: September 26, 2011
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Sinusitis
Procedure: Reverse Trendelenburg Position

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by St. Paul's Hospital, Canada:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 64
Study Start Date: October 2011
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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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  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442740

Locations
Canada, British Columbia
E.N.T. Clinic, St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
St. Paul's Hospital, Canada
Investigators
Principal Investigator: Amin R Javer, MD, FRCSC, FARS St. Paul's Hospital
  More Information

Publications:

Responsible Party: Amin Javer, Principal Investigator, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier: NCT01442740     History of Changes
Other Study ID Numbers: RTP-2011
Study First Received: September 26, 2011
Last Updated: August 28, 2013
Health Authority: Canada: Health Canada

Keywords provided by St. Paul's Hospital, Canada:
Functional Endoscopic Sinus Surgery
Reverse Trendelenburg Position

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 26, 2014