- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06515808
Effects of Three Airway Instruments on the Incidence of Postoperative Sore Throat
Effects of GlideScope, Pentax Airway Scope, and Macintosh Blade on the Incidence of Postoperative Sore Throat: A Cohort Study of 10,382 Patients
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New Taipei City, Taiwan, 24300
- Fu Jen Catholic University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients receiving inpatients surgery and general anesthesia with tracheal intubation
Exclusion Criteria:
Having difficult airway,
Anticipated difficult airway:
- Abnormal cervical spine movement or temporomandibular joint movement
- Airway-compromising masses such as tumors, cysts, or hematomas
- A Mallampati score greater than 3
- A thyromental distance of less than 6 cm
- A lesion below vocal cord
- A previously identified difficult airway
Unexpected difficult airway
- difficult mask ventilation
- 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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Direct Laryngoscope Group
Patients receiving tracheal intubation with direct laryngoscope
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Patient receiving tracheal intubation with direct laryngoscope, GlideScope or Airway Scope
Other Names:
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GlideScope Group
Patients receiving tracheal intubation with GlideScope
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|
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AirwayScope Group
Patients receiving tracheal intubation with AirwayScope
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative sore throat (POST)
Time Frame: 12 to 24 hours after general anesthesia is finished
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POST is defined by the presence of a self-reported foreign body sensation or a painful sensation in the throat after general anesthesia.
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12 to 24 hours after general anesthesia is finished
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Collaborators and Investigators
Investigators
- Principal Investigator: Chao Hsien Sung, MD, Fu Jen Catholic University Hospital, Fu Jen Catholic University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FJUH111171
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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