Enhancing Early Swallowing Recovery in Older Dysphagic Patients Afetr Anterior Cervical Spine Surgery

Enhancing Early Swallowing Recovery of Postoperative Rehabilitation Program in Older Patients With Subjective Dysphagia After Anterior Cervical Spine Surgery: a Randomized Controlled Trial

The early swallowing rehabilitation program in older patients receiving elective surgery is regarded to enhance the recovery pf swallowing ability. However, objective evidence of changes in swallowing in older patients after ACSS, or the effect of the early rehabilitation program on recovery, is limited.

The aim of this study is that changes in hypopharyngeal muscle after ACSS will be significantly higher in older patients who underwent rehabilitation program than those who did not go through the rehabilitation program. Postoperative pulmonary complications and mortality will be followed up until 5 weeks after ACSS.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypopharyngeal Pressure Changes Between Before and After Swallowing Rehabiliation
• Intervention / Treatment: Procedure: the early swallowing rehabilitation program

Detailed Description

Backgrounds: The number of aging patients is increasing. Aging is associated with an increased risk of dysphagia because of cerebral atrophy, deterioration in nerve function, and a region-dependent decline in muscle mass, which affects the swallowing mechanism. During the anterior approach cervical spine (ACSS) surgery, the upper esophageal sphincter (UES) and pharyngeal muscle group, especially the hypopharynx, is suspended to allow the surgeon to approach the cervical disc. The patients have an increased risk of dysphagia because traction injury of the UES and the muscle groups of the hypopharynx is unavoidable. The early swallowing rehabilitation program in older patients receiving elective surgery is regarded to enhance the recovery pf swallowing ability. However, objective evidence of changes in swallowing in older patients after ACSS, or the effect of the early rehabilitation program on recovery, is limited.

High resolution impedance manometry (HRIM) has been developed and used for the evaluation of dysphagia. HRIM involves multiple pressure sensors that detect changes in impedance as the food bolus is transmitted through the pharyngeal region. Eating Assessment Tool (EAT-10) is the most frequently used questionnaire for screening dysphagia, where score ≥4 is abnormal. Most previous studies used subjective questionnaire to investigate changes in perioperative swallowing after ACSS. One study that used HRIM to evaluate perioperative swallowing changes in ACSS patients found a decrease in muscle strength in the hypopharyngeal muscle groups. However, the study only recruited fourteen patients, and the mean age of the patients was 59 years old.

Aim and hypothesis: Investigators aim to investigate whether early swallowing rehabilitation can be used to enhance the hypopharyngeal muscle recovery after ACSS in aged patients with subjective dysphagia (EAT-10 score ≥4). The hypothesis is that changes in hypopharyngeal muscle after ACSS will be significantly higher in older patients who underwent rehabilitation program than those who did not go through the rehabilitation program. Postoperative pulmonary complications and mortality will be followed up until 5 weeks after ACSS.

Methods: Fifteen patients aged 60 to 80 years who underwent elective ACSS surgery will be recruited. All patients will have their HRIM measurement taken and answer the EAT-10 questionnaire before surgery. One week after ACSS, patients with EAT-10 scores≥4 will have their HRIM measurements taken and be randomized into either the intervention group, who will be enrolled in the early swallowing rehabilitation program, or the routine care group. The patients in the intervention group will return to the rehabilitation clinic after participating in the rehabilitation program for two weeks, during which their compliance will be monitored by daily phone reminders with a speech therapist or research assistant. After four weeks of participating in the rehabilitation program (i.e. five weeks after surgery), all patients in both the intervention and routine care groups will have their HRIM measurement taken and answer the EAT-10 questionnaire again. Postoperative pneumonia and mortality were followed up until five weeks after surgery.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chih-Jun Lai, MD; Phone Number: 0223123456; Email: littlecherrytw@gmail.com
• Study Contact Backup: Name: ‪Kuo-Liong Chien, PhD; Phone Number: 33668017; Email: klchien@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients aged 60 to 80 years who underwent elective ACSS surgery
• One week after ACSS, patients with EAT-10 scores≥4

Exclusion Criteria:

• patients have major organ dysfunction, such as hemodialysis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the early swallowing rehabilitation program; swallowing problem eveluated by high resolution impedance manometry (HRIM). The early swallowing rehabilitation program based on the results of HRIM evaluation	Procedure: the early swallowing rehabilitation program; the early swallowing rehabilitation program based on the HRIM evaluation
No Intervention: the routine care group; patients recieve swallowing education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The difference in pre-and postoperative hypopharyngeal pressure	preoperative condition to postoperative 5 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 22, 2022
• Primary Completion (Anticipated): August 22, 2027
• Study Completion (Anticipated): August 22, 2028

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 202206073RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: due to ethical issue

Drug and device information, study documents

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