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

NCT ID: NCT05420428

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-21
• Study Completion Date: 2023-12-04

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.

Conditions

Hypopharyngeal Mean Pressure

Study Design

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

Study Groups

endotracheal intubation

under general anesthesia, patients received tracheal intubation.

Group Type: PLACEBO_COMPARATOR

endotracheal intubation

Intervention Type: DEVICE

under general anesthesia, patients received endotracheal intubation

supraglottic airway device

under general anesthesia, patients received supraglottic airway device

Group Type: EXPERIMENTAL

supraglottic airway device

Intervention Type: DEVICE

under general anesthesia, patients received supraglottic airway device

Interventions

supraglottic airway device

under general anesthesia, patients received supraglottic airway device

Intervention Type: DEVICE

endotracheal intubation

under general anesthesia, patients received endotracheal intubation

Intervention Type: DEVICE

Other Intervention Names

laryngeal mask airway

Eligibility Criteria

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

• 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

Locations

Chih-Min Liu

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

202204071RINC

Identifier Type: -

Identifier Source: org_study_id