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

NCT05420428 | Completed

• 1 other identifier: 202204071RINC
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypopharyngeal Mean Pressure

Outcome Measures

Primary Outcomes (1)

• hypopharyngeal mean peak pressure

  hypopharyngeal pressure during food bolus transmittion

  15 minutes

Study Arms (2)

endotracheal intubation

PLACEBO COMPARATOR

under general anesthesia, patients received tracheal intubation.

Device: endotracheal intubation

supraglottic airway device

EXPERIMENTAL

under general anesthesia, patients received supraglottic airway device

Device: supraglottic airway device

Interventions

supraglottic airway device DEVICE

under general anesthesia, patients received supraglottic airway device

Also known as: laryngeal mask airway

supraglottic airway device

endotracheal intubation DEVICE

under general anesthesia, patients received endotracheal intubation

endotracheal intubation

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• The patients had severe major organ dysfunction

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Chih-Min Liu

Taipei, 100, Taiwan

Location

MeSH Terms

Interventions

Laryngeal Masks; Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: We masked the participants, care provider and outcomes assessor.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: controll group: tracheal intubation; intervention group: supraglottic airway device

Study Record Dates

• First Submitted: June 12, 2022
• First Posted: June 15, 2022
• Study Start: June 21, 2022
• Primary Completion: November 2, 2023
• Study Completion: December 4, 2023
• Last Updated: February 7, 2024

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)