Prospective Clinical Evaluation of the Taperguard Endotracheal Tube

NCT02450929 | Completed

• 1 other identifier: Taperguard
• Study Type: observational
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

post operative; pneumonia; vascular; orthopedic; urologic; neurologic

Outcome Measures

Primary Outcomes (1)

• incidence of postoperative pneumonia in a large surgical population

  up to 2 years

Study Arms (2)

Standard Barrel-Cuff ETT

Standard Barrel-Cuff ETT use in surgical patients

Taperguard ETT

Taperguard ETT use in surgical patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include data from all surgical patients enrolled in the National Surgical Quality Improvement Project (NSQIP) (IRB4621) who had surgery at OHSU between June 1, 2011 and May 31, 2014. We anticipate that we will enroll approximately 2500 subjects in each arm of the study.

You may qualify if:

• large general, vascular, orthopedic, urologic and neurologic surgical population

You may not qualify if:

• n/a

Sponsors & Collaborators

• Oregon Health and Science University: lead

Related Publications (1)

• Martini RP, Yanez ND, Treggiari MM, Tekkali P, Soelberg C, Aziz MF. Implementation of the TaperGuard endotracheal tube in an unselected surgical population to reduce postoperative pneumonia. BMC Anesthesiol. 2020 Aug 24;20(1):211. doi: 10.1186/s12871-020-01117-4.

  PMID: 32838740 DERIVED

MeSH Terms

Conditions

Pneumonia; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Aziz, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: May 21, 2015
• Study Start: December 12, 2012
• Primary Completion: April 1, 2016
• Study Completion: December 31, 2016
• Last Updated: August 21, 2018

Record last verified: 2018-08