Sore-throatNCT06515808
Effects of Three Airway Instruments on the Incidence of Postoperative Sore Throat
An observational study of Sore-throat, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sore-throat
- What is being tested?
- Direct Laryngoscope
- Type of treatment
- Medical device
- How many people
- 10,382 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2018to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent inpatient surgeries and general anesthesia with endotracheal tubes, intubated with direct laryngoscope, Pentax AirwayScope or GlideScope, during the period from January 1, 2018, to December 30, 2019, were included for the analysis.
Who may be able to join
- Patients receiving inpatients surgery and general anesthesia with tracheal intubation
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of GlideScope, Pentax Airway Scope, and Macintosh Blade on the Incidence of Postoperative Sore Throat: A Cohort Study of 10,382 Patients
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).
Read the 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.
- Conditions
- Sore-throat
- Being tested
- Direct Laryngoscope
- Keywords
- Glidescope, Macintosh Blade, Airway Scope, Postoperative sore throat, General Anesthesia
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct LaryngoscopeDevice
Also called GlideScope AVL, AirwayScope S100
Patient receiving tracheal intubation with direct laryngoscope, GlideScope or Airway Scope
| Study group | Role | What they receive |
|---|---|---|
| Direct Laryngoscope Group | Patients receiving tracheal intubation with direct laryngoscope Receives: Device: Direct Laryngoscope | |
| GlideScope Group | Patients receiving tracheal intubation with GlideScope | |
| AirwayScope Group | Patients receiving tracheal intubation with AirwayScope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative sore throat (POST)
POST is defined by the presence of a self-reported foreign body sensation or a painful sensation in the throat after general anesthesia.
Measured: 12 to 24 hours after general anesthesia is finished
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sore-throatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung, Chao-Hsien, Fu Jen Catholic University Hospital
- Investigators
- Chao Hsien Sung, MD, Principal investigator, Fu Jen Catholic University Hospital, Fu Jen Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515808
- Sponsor's protocol ID
- FJUH111171
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The data that support the findings of this study are not openly available due to institutional privacy guidelines but may be available from the corresponding author upon written request identifying the requestor, and the purpose and proposed use of the shared data.
Publications
Fu CH, Sung CH. Effects of GlideScope, Pentax Airway Scope, and Macintosh Blade on the incidence of postoperative sore throat: a cohort study of 9,881 patients. BMC Anesthesiol. 2024 Nov 12;24(1):409. doi: 10.1186/s12871-024-02798-x.
PubMed 39533185
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of GlideScope, Pentax Airway Scope, and Macintosh Blade on the Incidence of Postoperative Sore Throat: A Cohort Study of 10,382 Patients
- ClinicalTrials.gov ID
- NCT06515808
- Acronym / sponsor ID
- FJUH111171
- Conditions
- Sore-throat
- Keywords
- Glidescope, Macintosh Blade, Airway Scope, Postoperative sore throat, General Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,382 participants (actual)
- Lead sponsor
- Fu Jen Catholic University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Direct Laryngoscope Group | – | Device: Direct LaryngoscopePatients receiving tracheal intubation with direct laryngoscope |
| GlideScope Group | – | –Patients receiving tracheal intubation with GlideScope |
| AirwayScope Group | – | –Patients receiving tracheal intubation with AirwayScope |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent inpatient surgeries and general anesthesia with endotracheal tubes, intubated with direct laryngoscope, Pentax AirwayScope or GlideScope, during the period from January 1, 2018, to December 30, 2019, were included for the analysis.
Key inclusion criteria (1 listed)
- Patients receiving inpatients surgery and general anesthesia with tracheal intubation
Key exclusion criteria (16 listed)
- Having difficult airway,
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct LaryngoscopeAlso: GlideScope AVL, AirwayScope S100Patient receiving tracheal intubation with direct laryngoscope, GlideScope or Airway Scope | Device | Direct Laryngoscope Group |
Primary outcome
Postoperative sore throat (POST)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Derived from this study: PubMed 39533185Fu CH, Sung CH. Effects of GlideScope, Pentax Airway Scope, and Macintosh Blade on the incidence of postoperative sore throat: a cohort study of 9,881 patients. BMC Anesthesiol. 2024 Nov 12;24(1):409. doi: 10.1186/s12871-024-02798-x.
- Individual participant dataSharing planned: No. The data that support the findings of this study are not openly available due to institutional privacy guidelines but may be available from the corresponding author upon written request identifying the requestor, and the purpose and proposed use of the shared data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chao Hsien Sung, MD principal investigator
Fu Jen Catholic University Hospital, Fu Jen Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sore-throat, run by Fu Jen Catholic University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative sore throat (POST) (time frame: 12 to 24 hours after general anesthesia is finished). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06515808, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.