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

Not Applicable

Completed

• Conditions: Hypopharyngeal Mean Pressure
• Interventions: Device: supraglottic airway device; Device: endotracheal intubation

• Registration Number: NCT05420428
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-12
• Study First Submitted QC: 2022-06-12
• Study First Posted: 2022-06-15
• Study Start: 2022-06-21
• Primary Completion: 2023-11-02
• Study Completion: 2023-12-04
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• The patients receive orthopedic surgery with older than 60 years old including 60 years old.

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Exclusion Criteria

• The patients had severe major organ dysfunction

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
supraglottic airway device	supraglottic airway device	under general anesthesia, patients received supraglottic airway device
endotracheal intubation	endotracheal intubation	under general anesthesia, patients received tracheal intubation.

Primary Outcome Measures

Name	Time	Method
hypopharyngeal mean peak pressure	15 minutes	hypopharyngeal pressure during food bolus transmittion

Trial Locations

Locations (1)

Chih-Min Liu; 🇨🇳 Taipei, Taiwan