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

Sponsor

University of Mississippi Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT04251312

Collaborator

(none)

Enrollment

Location

Arm

23.5

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer Lung Cancer	Other: Oral Hygiene Education and Oral Hygiene Packets	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 14, 2020

Actual Primary Completion Date :

Dec 29, 2021

Actual Study Completion Date :

Dec 29, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Proportion of pneumonia [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216

Sponsors and Collaborators

University of Mississippi Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jacob Moremen, Assistant Professor of Cardio-Thoracic Surgery, University of Mississippi Medical Center

ClinicalTrials.gov Identifier:

NCT04251312

Other Study ID Numbers:

2019-0327

First Posted:

Jan 31, 2020

Last Update Posted:

Jun 23, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 23, 2022