Surgery Checklist and Process Improvement Surrounding Endoscopic Sinus Surgery

The purpose of this clinical trial is to evaluate the effectiveness of a new surgical checklist in the setting of sinus surgery for patients with chronic rhinosinusitis (CRS) and to measure the frequency of compliance by surgical personnel at OHSU with specific daily safety protocols before and after introduction of the checklist. The investigators hypothesized that the use of an ESS specific surgical checklist will improve the frequency of compliance by surgical personnel at OHSU to internal safety concerns and protocols.

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Key information

Conditions

Chronic Rhinosinusitis Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Disease Graft vs Host Disease Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Nose Diseases Organizing Pneumonia Otorhinolaryngologic Diseases Paranasal Sinus Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Sinusitis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

A total of 200 unidentified, non-randomized endoscopic sinus surgery cases will be observed and reviewed by research personnel (T.L.S, J.C.) within the Oregon Sinus Center, located within the Center for Health and Healing on the South Waterfront Campus of OHSU, under the direction of Timothy L. Smith, MD, MPH (PI). The first 100 surgical cases will be evaluated as "pre-intervention" cases by research personnel while the second 100 surgical cases will be evaluated as "post-intervention" cases after the introduction and discussion of the surgical checklist to operating room staff.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

CRS defined by 2007 Adult Sinusitis Guidelines.13
Unidentified adult patients electing endoscopic sinus surgery for the treatment of CRS.

Exclusion criteria

Unable to complete surgical procedures due to perioperative complications.

Treatment and study plan

Checklist introduction / Pause

Behavioral

Operating room staff will be introduced to a new checklist specifically designed to address concerns around protocols for endoscopic sinus surgery to raise awareness and attention to 11 specific areas of interest.

Primary outcomes

Sinus surgery checklist

Time frame: 6 months

11 dichotomous questions regarding observed operating room protocols for internal process improvement.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Dec 26, 2011
Registry last updated: Mar 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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