Minimizing Pathologic Aspiration in Patients Undergoing Esophageal and Lung Resections for Cancer

June 22, 2022 updated by: Jacob Moremen, University of Mississippi Medical Center
The aim of this study is to reduce pathologic aspiration and pneumonia in the perioperative period by providing an oral care and oral hygiene education to patients preoperatively. Patients enrolled in the study will be given a dysphagia screening questionnaire, an oral care package and oral hygiene education. Patients who screen positive for dysphagia will be referred to Speech Pathology for evaluation. The rate of postoperative pneumonia will be determined for those who participate in the study and will be compared to retrospective patient data from our institution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aspiration by high risk esophageal and lung cancer patients with either preexisting or post-therapy/post-operative dysphagia leads to morbidity (pneumonia) and mortality following surgery. The aim of this study is to reduce pathologic aspiration and pneumonia in the perioperative period by providing an oral care and oral hygiene education to patients preoperatively. Patients enrolled in the study will be given a dysphagia screening questionnaire, an oral care package and oral hygiene education. Patients who screen positive for dysphagia will be referred to Speech Pathology for evaluation. The rate of postoperative pneumonia will be determined for those who participate in the study and will be compared to retrospective patient data from our institution.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing elective esophageal or lung resections for cancer at our institution

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preoperative dental hygiene education
Patients who are scheduled for elective esophageal or lung resections who consent to participate will undergo oral hygiene education and be given an oral hygiene packet. An oral hygiene assessment using the Plaque Assessment tool will be conducted in the clinic. A Dysphagia Screening Tool questionnaire will also be administered. Patients who screen positive for dysphagia will be referred to Speech Pathology for evaluation but for the study purposes, the only data collected from the evaluation will be whether or not the participant received this intervention. A repeat dental exam will occur on the day of surgery. Patients will be followed for 30 days post operatively.
Other: Oral Hygiene Education and Oral Hygiene Packets
Patients will be educated on oral hygiene and will be given packets containing toothpaste, mouth rinse, floss and a toothbrush

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of pneumonia
Time Frame: 6 months
Number of participants who develop postoperative pneumonia in the interventional arm compared to the number of patients retrospectively reviewed who received no intervention
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mississippi Medical Center

Investigators

  • Principal Investigator: Jacob Moremen, M.D., University of Mississippi Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2020

Primary Completion (Actual)

December 29, 2021

Study Completion (Actual)

December 29, 2021

Study Registration Dates

First Submitted

January 16, 2020

First Submitted That Met QC Criteria

January 29, 2020

First Posted (Actual)

January 31, 2020

Study Record Updates

Last Update Posted (Actual)

June 23, 2022

Last Update Submitted That Met QC Criteria

June 22, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2019-0327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

After appropriate consent, patient charts will be reviewed by study members that have completed appropriate training. Protected Health Information (PHI) that will be accessed includes demographic data for patients such as Medical Record Number, date of surgery, planned operation, dental history, etc.(Also see the Data Collection Form). PHI will be collected and maintained in REDCap. For the retrospective review portion of the study, the charts of previous patients will be accessed. Data from those patients who underwent surgery within one year prior to beginning the study will be compared to the data collected during the study. Since obtaining consent for this portion of chart review will be difficult, we plan to request a HIPAA waiver of authorization.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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