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

NCT ID: NCT05494515

Last Updated: 2022-08-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-22
• Study Completion Date: 2028-08-22

Brief Summary

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.

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.

Conditions

Hypopharyngeal Pressure Changes Between Before and After Swallowing Rehabiliation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

the early swallowing rehabilitation program

Intervention Type: PROCEDURE

the early swallowing rehabilitation program based on the HRIM evaluation

the routine care group

patients recieve swallowing education

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

the early swallowing rehabilitation program

the early swallowing rehabilitation program based on the HRIM evaluation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Chih-Jun Lai, MD

Role: CONTACT

littlecherrytw@gmail.com

0223123456

‪Kuo-Liong Chien, PhD

Role: CONTACT

klchien@ntu.edu.tw

33668017

Other Identifiers

202206073RINB

Identifier Type: -

Identifier Source: org_study_id