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Prospective Clinical Evaluation of the Taperguard Endotracheal Tube

NCT02450929 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 102

Last updated 2018-08-21

No results posted yet for this study

Summary

This protocol is designed to determine if a transition from barrel-shaped cuff designs to the Taperguard endotracheal tube (ETT) reduces the incidence of postoperative pneumonia in a prospective evaluation of a large general, vascular, orthopedic, urologic and neurologic surgical population. The protocol was originally developed as a quality assurance project to evaluate a practice change that took place December 1, 2012. Data regarding postoperative pneumonia and related factors will be reviewed for the 18 months prior to the practice change and compared to data from the 14.5 months following the change. Since the results may be of interest to a wider audience, we are converting the project to a research study that may be published in the future.

The study will include data from all adult patients who had surgery at OHSU between June 1, 2011 and February 15, 2014. We anticipate that we will enroll approximately 40,000 subjects (at least 22,000 in the pre-intervention group and at least 16,000 in the post-intervention group). Data will be gathered from the OHSU electronic medical record system (Centricity and Epic).

6\. A multiple logistic regression analysis will be employed to determine the rates of pneumonia between the use of a standard barrel-cuff designed ETT and the Taperguard ETT for the defined group of surgical patients. The regression analysis would be adjusted for confounding variables including ASA status, age, use of paralytic, RSI with cricoid pressure, weight, pre-existing lung disease.

Conditions

  • Postoperative Pneumonia

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Michael Aziz, MD · Oregon Health and Science University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-12
Primary Completion
2016-04-01
Completion
2016-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02450929 on ClinicalTrials.gov