ERAS Swallowing Rehabilitation in Elder Patients

Effectivity of Early Recovery Accelerated Swallowing Program on Promoting Swallowing Recovery in Older Patients With High Risk of Oral Frailty Requiring Endotracheal Intubation During General Anesthesia: a Pilot Randomized Control Trial

The investigators studied that swallowing function of patients receiving the Early Recovery Accelerated Swallowing (ERAS-W program) training will recover fast than that of patients in the control group. The ERAS program training will be initiated before surgery and continue to after surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: The Upper Esophageal Sphincter Contraction Strength
• Intervention / Treatment: Behavioral: early rehabiliation swallowing program; Behavioral: not receiving early rehabilitation swallowing program

Detailed Description

The older patients (≥65 years old) with OFI-8≥4 undergoing elective orthopedic surgery requiring tracheal intubation will be recruited. Patients will be randomized into an intervention and a control group. Patients in the intervention groups will received the ERAS-W program, while those in the control group will receive the swallowing education video.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chih-Jun Lai, MD; Phone Number: +886-972652086; Email: littlecherrytw@gmail.com
• Study Contact Backup: Name: Chih-Min Liu, MD; Phone Number: _886-972652224; Email: lewisliu@ntuh.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• elective surgery
• general anesthesia with endotracheal intubation

Exclusion Criteria:

• major organ dysfunction, ex: chronic kidney disease, hear failure
• bleeding tendency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: patients receiving early rehabiliation swallowing program; the early rehabilitation program beginning from before to after surgery	Behavioral: early rehabiliation swallowing program; not receiving early rehabilitation swallowing program from before and after surgery
Placebo Comparator: patients not receiving early rehabilitation swallowing program; the Taiwan Dysphagia Society's publicly shared swallowing exercises for dysphagia, which is started from before to after surgery	Behavioral: not receiving early rehabilitation swallowing program; the Taiwan Dysphagia Society's publicly shared swallowing exercises for dysphagia, which is from before and after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
UES pressure, mmHg	about six months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 10, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: August 6, 2023
• First Submitted That Met QC Criteria: August 13, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 13, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 202303005RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: due to ethical problem

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No