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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypopharyngeal Mean Pressure
• Intervention / Treatment: Device: endotracheal intubation; Device: supraglottic airway device

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chih-Min Liu, MD; Phone Number: 62158 0223123456; Email: liu.chihmin@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Chih-Min Liu

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: endotracheal intubation; under general anesthesia, patients received tracheal intubation.	Device: endotracheal intubation; under general anesthesia, patients received endotracheal intubation
Experimental: supraglottic airway device; under general anesthesia, patients received supraglottic airway device	Device: supraglottic airway device; under general anesthesia, patients received supraglottic airway device; Other Names: laryngeal mask airway

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Actual): November 2, 2023
• Study Completion (Actual): December 4, 2023

Study Registration Dates

• First Submitted: June 12, 2022
• First Submitted That Met QC Criteria: June 12, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 202204071RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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