Effects of Three Airway Instruments on the Incidence of Postoperative Sore Throat

Completed

• Conditions: Sore-throat
• Interventions: Device: Direct Laryngoscope

• Registration Number: NCT06515808
• Lead Sponsor: Fu Jen Catholic University Hospital

Brief Summary

Postoperative sore throat (POST) is a common complaint after general anesthesia. POST is defined by the presence of a self-reported foreign body sensation or a painful sensation in the throat after general anesthesia. This condition may affect recovery and patient satisfaction and is associated with many factors, including intubation tools. Previous studies have reported conflicting results on POST. This retrospective cohort study, with sample size of 10,382 patients, was conducted to confirm the hypothesis that the use of video laryngoscopy (VL) is associated with a lower incidence of POST compared with direct laryngoscopy (DL).

Detailed Description

Background: Postoperative sore throat (POST) is a common complaint after general anesthesia. POST is defined by the presence of a self-reported foreign body sensation or a painful sensation in the throat after general anesthesia. This condition may affect recovery and patient satisfaction and is associated with many factors, including intubation tools. Previous studies have reported conflicting results on POST. This retrospective cohort study, with sample size of 10,382 patients, was conducted to confirm the hypothesis that the use of video laryngoscopy (VL) is associated with a lower incidence of POST compared with direct laryngoscopy (DL).

Methods: Data were extracted from a prospectively maintained quality improvement database. A total of 10,382 patients were included in the study. Statistical analysis was conducted for comparisons of demographic characteristics and to determine the effect of intubation tools on the incidence of POST.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-07
• Study First Submitted: 2024-07-14
• Study First Submitted QC: 2024-07-17
• Last Update Submitted: 2024-07-17
• Study First Posted: 2024-07-23
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10382

Inclusion Criteria

• Patients receiving inpatients surgery and general anesthesia with tracheal intubation

Exclusion Criteria

• Having difficult airway,

  • Anticipated difficult airway:

    1. Abnormal cervical spine movement or temporomandibular joint movement
    2. Airway-compromising masses such as tumors, cysts, or hematomas
    3. A Mallampati score greater than 3
    4. A thyromental distance of less than 6 cm
    5. A lesion below vocal cord
    6. A previously identified difficult airway

  • Unexpected difficult airway

    1. difficult mask ventilation
    2. difficult vocal cord visualization after multiple attempts of laryngoscopy

• Receiving laryngeal surgery, such as laryngeal biopsy, laryngeal microsurgery, laryngoplasty or vocal cord surgery,

• Not being extubated at the end of anesthesia,

• Being pregnant,

• Being under 20 years of age,

• American Society of Anesthesiologists (ASA) physical status class greater than 3.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Direct Laryngoscope Group	Direct Laryngoscope	Patients receiving tracheal intubation with direct laryngoscope

Primary Outcome Measures

Name	Time	Method
Postoperative sore throat (POST)	12 to 24 hours after general anesthesia is finished	POST is defined by the presence of a self-reported foreign body sensation or a painful sensation in the throat after general anesthesia.

Trial Locations

Locations (1)

Fu Jen Catholic University Hospital; 🇨🇳 New Taipei City, Taiwan