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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

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National Taiwan University

Status

Completed

Conditions

Hypopharyngeal Mean Pressure

Treatments

Device: endotracheal intubation
Device: supraglottic airway device

Study type

Interventional

Funder types

Other

Identifiers

NCT05420428
202204071RINC

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

60 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

32 participants in 2 patient groups, including a placebo group

endotracheal intubation
Placebo Comparator group
Description:
under general anesthesia, patients received tracheal intubation.
Treatment:
Device: endotracheal intubation
supraglottic airway device
Experimental group
Description:
under general anesthesia, patients received supraglottic airway device
Treatment:
Device: supraglottic airway device

Trial contacts and locations

1

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Central trial contact

Chih-Jun Lai, MD; Chih-Min Liu, MD

Data sourced from clinicaltrials.gov

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