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Not yet recruiting NCT05494515

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

No phase Interventional Hypopharyngeal Pressure Changes Between Before and After Swallowing Rehabiliation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: the early swallowing rehabilitation program.
Who it may be relevant to
Registry conditions: Hypopharyngeal Pressure Changes Between Before and After Swallowing Rehabiliation. Basic parameters: 60 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure the early swallowing rehabilitation program
    the early swallowing rehabilitation program based on the HRIM evaluation

Primary outcome measures

  • The difference in pre-and postoperative hypopharyngeal pressure [Time frame: preoperative condition to postoperative 5 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05494515 · 202206073RINB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗