Postoperative Sore ThroatNCT07077733
Comparison of Postoperative Sore Throat Following Endotracheal Intubation Performed With Videolaryngoscope, Videostylet, and Fiberoptic Bronchoscope
An observational study of Postoperative Sore Throat, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare video laryngoscope (VL), video stylet (VS), and fiberoptic bronchoscope (FOB) in elective endotracheal intubations of patients aged 18 to 65 years, classified as ASA I-II and without predicted difficult airways. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Sore Throat
- How many people
- 311 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 1 Jun 2025
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged between 18 and 65 years with an ASA physical status score of I or II, who underwent elective surgery under general anesthesia at the operating rooms of Hacettepe University Hospital, were enrolled.
Who may be able to join
- The requirement for endotracheal intubation for general anesthesia during elective surgery in our hospital
- Being between 18 and 65 years of age
- Having an ASA physical status classification of I or II
- Providing informed consent to participate in the study
Who cannot join
- Presence of a coagulation disorder
- Being identified as a patient with a predicted difficult airway (Patients anticipated to have a difficult airway during standard preoperative anesthesia evaluation and documented as such in the preoperative assessment notes. Relevant criteria include: Mallampati score of 3 or 4, upper lip bite test grade 3, short neck length, abnormal neck anatomy or limited neck mobility, micrognathia/retrognathia, facial deformities/trauma, and mouth opening less than 3 cm.)
- Presence of obesity (body mass index > 35 kg/m²)
- Undergoing head and neck surgery in which postoperative sore throat is expected due to the surgical site
- Placement of a nasogastric (NG) tube during surgery, which may contribute to postoperative sore throat
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe Üniversitesi
Ankara, altındağ, 06230
About this study
This study aims to compare video laryngoscope (VL), video stylet (VS), and fiberoptic bronchoscope (FOB) in elective endotracheal intubations of patients aged 18 to 65 years, classified as ASA I-II and without predicted difficult airways. The primary endpoints are the incidence of postoperative sore throat and hoarseness, while secondary endpoints include intubation time, first-attempt intubation success, hemodynamic responses, and procedure-related complications. Postoperative sore throat and hoarseness will be assessed at the bedside at the 20th minute and 6th hour following extubation.
Read the detailed description
Objective: The selection of an appropriate device for endotracheal intubation is essential for successful airway management. Although various publications in the literature compare the techniques used for intubation in terms of their advantages and disadvantages, there remains a lack of consensus regarding the superiority of one method over another. This study aims to compare video laryngoscope (VL), video stylet (VS) and fiberoptic bronchoscope (FOB) devices in patients without anticipated difficult airway undergoing elective intubation, primarily in terms of postoperative sore throat and hoarseness, and secondarily in terms of intubation time, first-attempt success rate, hemodynamic responses, and complications.
Materials and Methods: The study included patients aged 18-65 years, with ASA physical status I-II, who underwent elective surgery under general anesthesia at the operating rooms of Hacettepe University Hospitals, and who had no predictors of a difficult airway. Patients were allocated into three groups: Group VL (n=105) was intubated using the iS3-L Video Laryngoscope (Shenzhen Insighters Medical Technology, Gaung Dong, China); Group VS (n=102) using the iS3-R Video Rigid Stylet (Shenzhen Insighters Medical Technology, Gaung Dong, China); and Group FOB (n=104) using the iS3-C Video Flexible Laryngoscope (Shenzhen Insighters Medical Technology, Gaung Dong, China).
The primary outcome was the incidence of postoperative sore throat and hoarseness at the 20th minute and 6th hour postoperatively. Secondary outcomes included intubation time, first-attempt success rate, hemodynamic responses to intubation, and complications during the procedure.
Sample size calculations were performed using the G*Power 3.1.9.6 (Franz Faul, Universität Kiel, Kiel, Germany) software. To detect at least a 20% difference in the incidence of postoperative sore throat between any two groups with 80% power and a 5% significance level, the required total sample size was calculated as 294 patients. However, accounting for potential exclusions and data loss, a minimum of 102 patients per group was targeted.
This was a non-randomized, comparative clinical study. The anesthesiologist responsible for each case was not interfered with regarding the management of general anesthesia or the method of endotracheal tube insertion.
- Conditions
- Postoperative Sore Throat
- Keywords
- videolaryngoscope, videostylet, fiberoptic bronchoscope, postoperative sore throat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Video laryngoscopy | Patients who underwent intubation using a videolaryngoscope | |
| Video stylet | Patients who underwent intubation using a video stylet | |
| Fiberoptic bronchoscopy | Patients who underwent intubation using fiberoptic bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative sore throat and hoarseness
Primary aim of this study is to compare video laryngoscope (VL), video stylet (VS) and fiberoptic bronchoscope (FOB) devices in patients without anticipated difficult airway undergoing elective intubation, in terms of postoperative sore throat and hoarseness at the 20th minute and 6th hour postoperatively.
Measured: 6 hours postoperatively
Secondary outcomes (4)
intubation time
The duration between the placement of the airway device, selected by the attending anesthesiologist, into the patient's mouth and the confirmation of successful intubation (as indicated by the appearance of end-tidal CO₂ on the capnograph) was recorded as the intubation time.
Measured: from the beginning to the end of the intubation procedure
first-attempt success rate
The success of intubation with the selected airway device on the first attempt was recorded; in cases where the first attempt failed, the total number of intubation attempts was noted.
Measured: from the beginning to the end of the intubation procedure
hemodynamic responses to intubation
The patient's hemodynamic changes during intubation were noted
Measured: from the beginning to the end of the intubation procedure
complications during the intubation
Complications during intubation were noted
Measured: from the beginning to the end of the intubation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Apr 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Sore ThroatStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ayşe meryem yalçın, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077733
- Sponsor's protocol ID
- KA-23060
- Status last verified
- Aug 2026
- First submitted
- 28 Jun 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Sore Throat Following Endotracheal Intubation Performed With Videolaryngoscope, Videostylet, and Fiberoptic Bronchoscope
- ClinicalTrials.gov ID
- NCT07077733
- Acronym / sponsor ID
- KA-23060
- Conditions
- Postoperative Sore Throat
- Keywords
- videolaryngoscope, videostylet, fiberoptic bronchoscope, postoperative sore throat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 22 Jul 2025 (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.
This study aims to compare video laryngoscope (VL), video stylet (VS), and fiberoptic bronchoscope (FOB) in elective endotracheal intubations of patients aged 18 to 65 years, classified as ASA I-II and without predicted difficult airways. The primary endpoints are the incidence of postoperative sore throat and hoarseness, while secondary endpoints include intubation time, first-attempt intubation success, hemodynamic responses, and procedure-related complications. Postoperative sore throat and hoarseness will be assessed at the bedside at the 20th minute and 6th hour following extubation.
Detailed description
Objective: The selection of an appropriate device for endotracheal intubation is essential for successful airway management. Although various publications in the literature compare the techniques used for intubation in terms of their advantages and disadvantages, there remains a lack of consensus regarding the superiority of one method over another. This study aims to compare video laryngoscope (VL), video stylet (VS) and fiberoptic bronchoscope (FOB) devices in patients without anticipated difficult airway undergoing elective intubation, primarily in terms of postoperative sore throat and hoarseness, and secondarily in terms of intubation time, first-attempt success rate, hemodynamic responses, and complications.
Materials and Methods: The study included patients aged 18-65 years, with ASA physical status I-II, who underwent elective surgery under general anesthesia at the operating rooms of Hacettepe University Hospitals, and who had no predictors of a difficult airway. Patients were allocated into three groups: Group VL (n=105) was intubated using the iS3-L Video Laryngoscope (Shenzhen Insighters Medical Technology, Gaung Dong, China); Group VS (n=102) using the iS3-R Video Rigid Stylet (Shenzhen Insighters Medical Technology, Gaung Dong, China); and Group FOB (n=104) using the iS3-C Video Flexible Laryngoscope (Shenzhen Insighters Medical Technology, Gaung Dong, China).
The primary outcome was the incidence of postoperative sore throat and hoarseness at the 20th minute and 6th hour postoperatively. Secondary outcomes included intubation time, first-attempt success rate, hemodynamic responses to intubation, and complications during the procedure.
Sample size calculations were performed using the G*Power 3.1.9.6 (Franz Faul, Universität Kiel, Kiel, Germany) software. To detect at least a 20% difference in the incidence of postoperative sore throat between any two groups with 80% power and a 5% significance level, the required total sample size was calculated as 294 patients. However, accounting for potential exclusions and data loss, a minimum of 102 patients per group was targeted.
This was a non-randomized, comparative clinical study. The anesthesiologist responsible for each case was not interfered with regarding the management of general anesthesia or the method of endotracheal tube insertion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Video laryngoscopy | – | –Patients who underwent intubation using a videolaryngoscope |
| Video stylet | – | –Patients who underwent intubation using a video stylet |
| Fiberoptic bronchoscopy | – | –Patients who underwent intubation using fiberoptic bronchoscopy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged between 18 and 65 years with an ASA physical status score of I or II, who underwent elective surgery under general anesthesia at the operating rooms of Hacettepe University Hospital, were enrolled.
Key inclusion criteria (4 listed)
- The requirement for endotracheal intubation for general anesthesia during elective surgery in our hospital
- Being between 18 and 65 years of age
- Having an ASA physical status classification of I or II
- Providing informed consent to participate in the study
Key exclusion criteria (6 listed)
- Presence of a coagulation disorder
- Being identified as a patient with a predicted difficult airway (Patients anticipated to have a difficult airway during standard preoperative anesthesia evaluation and documented as such in the preoperative assessment notes. Relevant criteria include: Mallampati score of 3 or 4, upper lip bite test grade 3, short neck length, abnormal neck anatomy or limited neck mobility, micrognathia/retrognathia, facial deformities/trauma, and mouth opening less than 3 cm.)
- Presence of obesity (body mass index > 35 kg/m²)
- Undergoing head and neck surgery in which postoperative sore throat is expected due to the surgical site
- Placement of a nasogastric (NG) tube during surgery, which may contribute to postoperative sore throat
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of postoperative sore throat and hoarseness
Time frame: 6 hours postoperatively
Primary aim of this study is to compare video laryngoscope (VL), video stylet (VS) and fiberoptic bronchoscope (FOB) devices in patients without anticipated difficult airway undergoing elective intubation, in terms of postoperative sore throat and hoarseness at the 20th minute and 6th hour postoperatively.
4 secondary outcomes
intubation time
Time frame: from the beginning to the end of the intubation procedure
first-attempt success rate
Time frame: from the beginning to the end of the intubation procedure
hemodynamic responses to intubation
Time frame: from the beginning to the end of the intubation procedure
complications during the intubation
Time frame: from the beginning to the end of the intubation procedure
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 27 Aug 2026.
- Individual participant dataSharing planned: Yes
Related trials for Postoperative Sore Throat
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
Active, not recruitingObservational study
Dexmedetomidine Nasal Spray and Postoperative Sore Throat After Bronchoscopy
Postoperative Sore Throat, Bronchoscopy
Not yet recruiting
The Effect of Compound Chamomile and Lidocaine Hydronchloride Gel as an Endotracheal Tube Lubricant on Postoperative Pharyngeal and Laryngeal Complications in Thoracic Surgery Patients
Postoperative Sore Throat
Not yet recruiting
Effect of Laryngeal Mask Cuff Shape on Pharyngeal Stress
Anesthesia, General, Airway Management
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Postoperative Sore Throat, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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 27 Aug 2026. 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 Turkey (Türkiye). 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?
incidence of postoperative sore throat and hoarseness (time frame: 6 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2026.