Applying High Resolution Impedance Manometry for Perioperative Swallowing Changes in Older Patients Receiving Endotracheal Intubation or Supraglottic Airway Devices During Orthopedic Surgery

Study Overview
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Brief Summary
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We aimed to investigate whether patients with tracheal intubation has high hypopharyngeal pressure than patients with supraglottic airway does by using high resolution impedance manometry. We expected that the patients with endotracheal intubation have higher hypopharyngeal pressure than the patients with supraglottic airway devices.

Detailed Description
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Background: More and more older patients required to receive orthopedic surgery recently. The intubation or supraglottic airway device are required to maintain airway during general anesthesia. Previous studies only reported the subjective swallowing discomfort feeling, however, the objective data was limited. The high-resolution impedance manometry could detect the swallowing muscle power changes with multiple pressure sensors and impedance channels. Objectives: we aimed to investigate whether patients with tracheal intubation has high hypopharyngeal pressure than patients with supraglottic airway does Patients and methods: The patients receive orthopedic surgery with older than 60 years old. They received high resolution impedance manometry examination at preoperative day, in the post-anesthetic care unit, postoperative day 3 to 7 (pick a day) along with subjective questionnaires. We also followed the IDDSI guideline to test different viscosity of the patients' tolerance for food. Expected result: The patients with endotracheal intubation have higher hypopharyngeal pressure than the patients with supraglottic airway devices.

Official Title
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Applying High Resolution Impedance Manometry for Perioperative Swallowing Changes in Older Patients Receiving Endotracheal Intubation or Supraglottic Airway Devices During Orthopedic Surgery: a Pilot Randomized Controlled Trial

Conditions
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Hypopharyngeal Mean Pressure

Intervention / Treatment
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* Device: supraglottic airway device
* Device: endotracheal intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients receive orthopedic surgery with older than 60 years old including 60 years old. Exclusion Criteria: The patients had severe major organ dysfunction

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: controll group: tracheal intubation; intervention group: supraglottic airway device
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: endotracheal intubation<br>under general anesthesia, patients received tracheal intubation. | Device: endotracheal intubation<br>* under general anesthesia, patients received endotracheal intubation<br>|
| Experimental: supraglottic airway device<br>under general anesthesia, patients received supraglottic airway device | Device: supraglottic airway device<br>* under general anesthesia, patients received supraglottic airway device<br>* Other names: laryngeal mask airway;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypopharyngeal mean peak pressure | hypopharyngeal pressure during food bolus transmittion | 15 minutes |