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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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05420428
Collaborator
(none)
30
Enrollment
2
Arms
66.3
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: supraglottic airway device
  • Device: endotracheal intubation
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
controll group: tracheal intubation; intervention group: supraglottic airway devicecontroll group: tracheal intubation; intervention group: supraglottic airway device
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
We masked the participants, care provider and outcomes assessor.
Primary Purpose:
Prevention
Official Title:
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
Anticipated Study Start Date :
Jun 21, 2022
Anticipated Primary Completion Date :
Dec 31, 2026
Anticipated Study Completion Date :
Dec 31, 2027

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. hypopharyngeal mean peak pressure [15 minutes]

      hypopharyngeal pressure during food bolus transmittion

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT05420428
    Other Study ID Numbers:
    • 202204071RINC
    First Posted:
    Jun 15, 2022
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 15, 2022