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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04251312
• Other study ID #: 2019-0327
• Status: Completed
• Phase: N/A
• Start date: January 14, 2020
• Est. completion date: December 29, 2021

Study information

• Verified date: June 2022
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 29, 2021
• Est. primary completion date: December 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Esophageal Cancer
• Lung Cancer

Intervention

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

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hernán MA, Robins JM. Estimating causal effects from epidemiological data. J Epidemiol Community Health. 2006 Jul;60(7):578-86. — View Citation

Semenkovich TR, Frederiksen C, Hudson JL, Subramanian M, Kollef MH, Patterson GA, Kreisel D, Meyers BF, Kozower BD, Puri V. Postoperative Pneumonia Prevention in Pulmonary Resections: A Feasibility Pilot Study. Ann Thorac Surg. 2019 Jan;107(1):262-270. do — View Citation

Soutome S, Yanamoto S, Funahara M, Hasegawa T, Komori T, Yamada SI, Kurita H, Yamauchi C, Shibuya Y, Kojima Y, Nakahara H, Oho T, Umeda M. Effect of perioperative oral care on prevention of postoperative pneumonia associated with esophageal cancer surgery — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of pneumonia	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