Airway Complication of AnesthesiaNCT06950957
Video Laryngeal Mask vs. Endotracheal Tube in Septoplasty
An observational study of Airway Complication of Anesthesia and Septoplasty, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
This single-center, prospective, observational, comparative study evaluated airway management using the SaCoVLM™ video laryngeal mask airway (VLMA) and a conventional endotracheal tube (ETT) in adult patients undergoing elective septoplasty under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Airway Complication of Anesthesia, Septoplasty
- What is being tested?
- Video Laryngeal Mask Airway (VLMA) and Endotracheal Tube (ETT)
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2025to 4 Nov 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
- No healthy volunteers
- Adult, Older adult
Study population: This study included adult patients aged 18-65 years with ASA physical status I-II who underwent elective septoplasty under general anesthesia. Patients were classified into the VLMA or ETT cohort according to the airway device selected by the responsible anesthesiologist during routine clinical practice. No randomization was performed. Patients with an anticipated difficult airway, body mass index greater than 30 kg/m², gastroesophageal reflux disease or hiatal hernia, or pregnancy were excluded.
Who may be able to join
- Patients aged 18-65 years
- ASA physical status I-II
- Patients scheduled for elective septoplasty under general anesthesia
Who cannot join
- Anticipated difficult airway
- ASA physical status III-IV
- History of gastroesophageal reflux disease or hiatal hernia
- Body mass index greater than 30 kg/m²
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun University, Samsun Training and Research Hospital
Samsun, Ilkadim, 55000
About this study
Official title: Comparison of Video Laryngeal Mask Airway and Endotracheal Tube Use for Airway Safety in Patients Undergoing Septoplasty
This single-center, prospective, observational, comparative study evaluated airway management using the SaCoVLM™ video laryngeal mask airway (VLMA) and a conventional endotracheal tube (ETT) in adult patients undergoing elective septoplasty under general anesthesia.
The airway device was selected by the responsible anesthesiologist as part of routine clinical practice, without randomization.
Read more
The primary outcome was airway blood contamination assessed at the end of surgery. Secondary outcomes included hemodynamic responses, ventilation parameters, airway device placement characteristics, recovery time, surgeon satisfaction, and postoperative airway-related symptoms.
Distal tracheal blood contamination was assessed using flexible bronchoscopy in both groups. Postoperative sore throat, dysphagia, cough, and hoarseness were evaluated during recovery and at predetermined postoperative intervals. Comparative analyses of postoperative symptoms were limited to the first 12 hours because 24-hour follow-up data were incomplete.
Read the detailed description
This single-center, prospective, observational, comparative study included adult patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II who underwent elective septoplasty under general anesthesia.
Patients were evaluated in two groups according to the airway device selected by the responsible anesthesiologist during routine clinical practice: the SaCoVLM™ video laryngeal mask airway (VLMA) group and the conventional endotracheal tube (ETT) group. No randomization was performed. A total of 64 patients, 32 in each group, were included in the final analysis.
Standard monitoring included electrocardiography, noninvasive arterial blood pressure, peripheral oxygen saturation, end-tidal carbon dioxide, and bispectral index monitoring. Anesthesia was induced with intravenous fentanyl and propofol and maintained with sevoflurane and remifentanil. Volume-controlled ventilation was standardized using a tidal volume of 6-8 mL/kg, a respiratory rate of 12 breaths/min, a positive end-expiratory pressure of 5 cmH2O, and an inspiratory-to-expiratory ratio of 1:2.
Hemodynamic and respiratory parameters were recorded at baseline, after anesthesia induction immediately before airway device placement, at 1, 3, 5, 10, 15, and 30 minutes after placement, and 5 minutes after airway device removal.
The primary outcome was airway blood contamination assessed at the end of surgery using a four-point scale: 1 = no blood, 2 = mild contamination, 3 = moderate contamination, and 4 = severe contamination.
In the VLMA group, proximal glottic blood contamination was assessed directly using the integrated camera. In the ETT group, proximal blood contamination was assessed indirectly by examining blood around the endotracheal tube cuff following careful aspiration of the posterior oropharynx and extubation. These proximal assessment methods were device-specific and not anatomically equivalent.
Distal tracheal blood contamination was evaluated using flexible bronchoscopy in all 64 patients, including all 32 patients in the VLMA group and all 32 patients in the ETT group, regardless of proximal blood contamination findings.
Secondary outcomes included airway insertion time, number of placement attempts, ease of placement, ventilation leakage, peak airway pressure, glottic visualization, surgeon satisfaction, and early postoperative recovery characteristics.
Early postoperative recovery was evaluated using recovery time and the Modified Aldrete Score. Postoperative sore throat, dysphagia, cough, and hoarseness were assessed in the post-anesthesia care unit and at 2, 8, 12, and 24 hours after surgery. Although 24-hour follow-up was planned, complete data were available for only 24 of the 64 patients. Therefore, comparative analyses of postoperative airway morbidity were restricted to assessments through 12 hours.
Airway complications, including laryngospasm and bronchospasm, were also recorded.
- Conditions
- Airway Complication of Anesthesia, Septoplasty
- Being tested
- Video Laryngeal Mask Airway (VLMA), Endotracheal Tube (ETT)
- Keywords
- Septoplasty, Laryngeal Mask Airway, Endotracheal Tube, Postoperative Sore Throat, Otorhinolaryngology Surgery, Supraglottic Airway Devices, Postoperative Sore Throat (POST Score), Airway Blood Contamination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Laryngeal Mask Airway (VLMA)Device
The SaCoVLM™ video laryngeal mask airway, a supraglottic airway device with an integrated camera, was used for airway management during elective septoplasty. The integrated camera enabled direct visualization of the glottic inlet and assessment of proximal blood contamination. At the end of surgery, distal tracheal blood contamination was assessed using flexible bronchoscopy in all 32 VLMA patients included in the final analysis, regardless of proximal blood contamination findings. Airway insertion characteristics, ventilation and hemodynamic parameters, recovery outcomes, and postoperative airway morbidity were recorded.
Endotracheal Tube (ETT)Device
A conventional cuffed endotracheal tube was inserted using direct laryngoscopy for airway management during elective septoplasty. At the end of surgery, the distal trachea was examined for blood contamination using flexible bronchoscopy through the ETT before removal. Proximal tracheal/glottic contamination was assessed indirectly by examining blood around the distal portion of the ETT cuff after aspiration of the posterior oropharynx and extubation. Airway insertion characteristics, ventilation and hemodynamic parameters, recovery outcomes, and postoperative airway morbidity were recorded.
| Study group | Role | What they receive |
|---|---|---|
| VLMA Group | The proximal glottic region was evaluated using the device's integrated camera. Distal tracheal blood contamination was assessed using flexible bronchoscopy in all patients in this cohort, regardless of the presence or absence of proximal blood contamination. Receives: Device: Video Laryngeal Mask Airway (VLMA) | |
| ETT Group | Participants whose airway was managed with a conventional endotracheal tube (ETT) inserted using direct laryngoscopy during routine clinical practice were included in this cohort. At the end of surgery, the distal trachea was examined using flexible bronchoscopy through the ETT before removal. Proximal tracheal/glottic contamination was assessed indirectly by examining blood around the distal portion of the ETT cuff after aspiration of the posterior oropharynx and extubation. Perioperative hemodynamic and ventilation parameters, airway placement characteristics, recovery outcomes, and postoperative airway morbidity were recorded. Receives: Device: Endotracheal Tube (ETT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal Tracheal/Glottic and Distal Tracheal Blood Contamination Scores
Airway blood contamination was assessed at the end of surgery using a four-point ordinal scale: 1 = no blood, 2 = mild, 3 = moderate, and 4 = severe contamination. Higher scores indicated greater contamination.
In the VLMA group, proximal blood was assessed directly using the integrated camera. In the ETT group, proximal blood was assessed indirectly by inspecting blood around the ETT cuff after oropharyngeal suctioning and extubation. The proximal assessment methods were not equivalent.
Distal tracheal blood contamination was assessed by flexible bronchoscopy in all 64 patients (32 per group), regardless of proximal findings. Scores were recorded separately for each anatomical level and summarized by the number and percentage of participants in each category. No total score was calculated.
Measured: At the end of surgery, immediately before and after airway device removal.
Secondary outcomes (10)
Heart Rate (HR)
Heart rate, measured in beats per minute, was recorded at preoperative baseline; after anesthesia induction immediately before airway device placement; at 1, 3, 5, 10, 15, and 30 minutes after successful airway device placement; and at 5 minutes after airway device removal.
Measured: From preoperative baseline to 5 minutes after airway device removal.
Postoperative Sore Throat (POST Score)
Postoperative sore throat was assessed by direct patient questioning using a four-point ordinal scale: 0 = no sore throat; 1 = cold-like sensation or minimal discomfort; 2 = mild-to-moderate pain during swallowing; and 3 = continuous pain without swallowing. Assessments were scheduled in the post-anesthesia care unit and at 2, 8, 12, and 24 hours postoperatively. Due to incomplete follow-up at 24 hours, the comparative analysis was limited to assessments through 12 hours.
Measured: From the post-anesthesia care unit through 24 hours postoperatively (assessments at recovery, 2, 8, 12, and 24 hours).
Arterial Blood Pressure
Systolic, diastolic, and mean arterial blood pressures, measured in mmHg, were recorded at preoperative baseline; after anesthesia induction immediately before airway device placement; at 1, 3, 5, 10, 15, and 30 minutes after successful airway device placement; and at 5 minutes after airway device removal.
Measured: From preoperative baseline to 5 minutes after airway device removal.
Airway Insertion Time
Airway insertion time was recorded in seconds. In the ETT group, it was defined as the time from the start of the intubation attempt until three consecutive regular end-tidal carbon dioxide waveforms were observed on capnography. In the VLMA group, it was defined as the time from picking up the device until three consecutive regular end-tidal carbon dioxide waveforms were observed on capnography.
Measured: Assessed once during airway device placement, immediately after anesthesia induction.
Intraoperative and Early Postoperative Airway Complications
The occurrence of laryngospasm and bronchospasm was assessed through clinical observation during the intraoperative and early postoperative periods. Each complication was recorded separately as present or absent.
Measured: From anesthesia induction through the early postoperative period in the post-anesthesia care unit.
Postoperative Dysphagia
Postoperative dysphagia was assessed by direct patient questioning using a four-point ordinal scale: 0 = no swallowing difficulty; 1 = minimal discomfort during swallowing; 2 = mild-to-moderate difficulty during swallowing; and 3 = marked swallowing difficulty. Assessments were scheduled in the post-anesthesia care unit and at 2, 8, 12, and 24 hours postoperatively. Due to incomplete follow-up at 24 hours, the comparative analysis was limited to assessments through 12 hours.
Measured: From the post-anesthesia care unit through 24 hours postoperatively (assessments at recovery, 2, 8, 12, and 24 hours).
First-Attempt Success Rate of Airway Device Insertion
First-attempt success was recorded separately for each airway device as successful or unsuccessful. The total number of placement attempts required to achieve successful airway placement was also recorded. Successful placement was confirmed by three consecutive regular end-tidal carbon dioxide waveforms.
Measured: Assessed once during airway device placement immediately after anesthesia induction.
Postoperative Cough
Postoperative cough was assessed using a four-point scale: 0 = no cough; 1 = mild cough; 2 = moderate cough; and 3 = severe cough. For statistical analysis, scores were categorized as absent (0) or present (1-3). Results were expressed as the number and percentage of patients with cough in each group. Assessments were scheduled during recovery and at 2, 8, 12, and 24 hours postoperatively. Comparative analyses were limited to 12 hours because of incomplete 24-hour follow-up.
Measured: During recovery and at 2, 8, 12, and 24 hours postoperatively.
Postoperative Hoarseness
Postoperative hoarseness was assessed using a four-point scale: 0 = no hoarseness; 1 = mild voice changes; 2 = moderate voice changes; and 3 = marked hoarseness. For statistical analysis, scores were categorized as absent (0) or present (1-3). Results were expressed as the number and percentage of patients with hoarseness in each group. Assessments were scheduled during recovery and at 2, 8, 12, and 24 hours postoperatively. Comparative analyses were limited to 12 hours because of incomplete 24-hour follow-up.
Measured: During recovery and at 2, 8, 12, and 24 hours postoperatively.
Surgeon Satisfaction With Surgical Conditions
Surgeon satisfaction with surgical conditions was assessed at the end of surgery using a four-point ordinal scale: 0 = very good, 1 = good, 2 = poor, and 3 = very poor (surgical conditions unsuitable for initiating the procedure). Lower scores indicated greater satisfaction. Results were expressed as the number and percentage of patients in each category for both groups.
Measured: At the end of surgery (single assessment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start30 Apr 2025
- Primary completion3 Nov 2025
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Airway Complication of AnesthesiaStudies 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
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hatice Selcuk KUSDERCI, M.D., Study director, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950957
- Sponsor's protocol ID
- GOKAEK 2025/3/15
- Status last verified
- Oct 2026
- First submitted
- 24 Mar 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kaplan A, Crosby GJ, Bhattacharyya N. Airway protection and the laryngeal mask airway in sinus and nasal surgery. Laryngoscope. 2004 Apr;114(4):652-5. doi: 10.1097/00005537-200404000-00010.
PubMed 15064618Karaaslan E, Akbas S, Ozkan AS, Colak C, Begec Z. A comparison of laryngeal mask airway-supreme and endotracheal tube use with respect to airway protection in patients undergoing septoplasty: a randomized, single-blind, controlled clinical trial. BMC Anesthesiol. 2021 Jan 7;21(1):5. doi: 10.1186/s12871-020-01222-4.
PubMed 33407130
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Video Laryngeal Mask Airway and Endotracheal Tube Use for Airway Safety in Patients Undergoing Septoplasty
- ClinicalTrials.gov ID
- NCT06950957
- Acronym / sponsor ID
- GOKAEK 2025/3/15
- Conditions
- Airway Complication of Anesthesia, Septoplasty
- Keywords
- Septoplasty, Laryngeal Mask Airway, Endotracheal Tube, Postoperative Sore Throat, Otorhinolaryngology Surgery, Supraglottic Airway Devices, Postoperative Sore Throat (POST Score), Airway Blood Contamination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 30 Apr 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 single-center, prospective, observational, comparative study evaluated airway management using the SaCoVLM™ video laryngeal mask airway (VLMA) and a conventional endotracheal tube (ETT) in adult patients undergoing elective septoplasty under general anesthesia.
The airway device was selected by the responsible anesthesiologist as part of routine clinical practice, without randomization.
The primary outcome was airway blood contamination assessed at the end of surgery. Secondary outcomes included hemodynamic responses, ventilation parameters, airway device placement characteristics, recovery time, surgeon satisfaction, and postoperative airway-related symptoms.
Distal tracheal blood contamination was assessed using flexible bronchoscopy in both groups. Postoperative sore throat, dysphagia, cough, and hoarseness were evaluated during recovery and at predetermined postoperative intervals. Comparative analyses of postoperative symptoms were limited to the first 12 hours because 24-hour follow-up data were incomplete.
Detailed description
This single-center, prospective, observational, comparative study included adult patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II who underwent elective septoplasty under general anesthesia.
Patients were evaluated in two groups according to the airway device selected by the responsible anesthesiologist during routine clinical practice: the SaCoVLM™ video laryngeal mask airway (VLMA) group and the conventional endotracheal tube (ETT) group. No randomization was performed. A total of 64 patients, 32 in each group, were included in the final analysis.
Standard monitoring included electrocardiography, noninvasive arterial blood pressure, peripheral oxygen saturation, end-tidal carbon dioxide, and bispectral index monitoring. Anesthesia was induced with intravenous fentanyl and propofol and maintained with sevoflurane and remifentanil. Volume-controlled ventilation was standardized using a tidal volume of 6-8 mL/kg, a respiratory rate of 12 breaths/min, a positive end-expiratory pressure of 5 cmH2O, and an inspiratory-to-expiratory ratio of 1:2.
Hemodynamic and respiratory parameters were recorded at baseline, after anesthesia induction immediately before airway device placement, at 1, 3, 5, 10, 15, and 30 minutes after placement, and 5 minutes after airway device removal.
The primary outcome was airway blood contamination assessed at the end of surgery using a four-point scale: 1 = no blood, 2 = mild contamination, 3 = moderate contamination, and 4 = severe contamination.
In the VLMA group, proximal glottic blood contamination was assessed directly using the integrated camera. In the ETT group, proximal blood contamination was assessed indirectly by examining blood around the endotracheal tube cuff following careful aspiration of the posterior oropharynx and extubation. These proximal assessment methods were device-specific and not anatomically equivalent.
Distal tracheal blood contamination was evaluated using flexible bronchoscopy in all 64 patients, including all 32 patients in the VLMA group and all 32 patients in the ETT group, regardless of proximal blood contamination findings.
Secondary outcomes included airway insertion time, number of placement attempts, ease of placement, ventilation leakage, peak airway pressure, glottic visualization, surgeon satisfaction, and early postoperative recovery characteristics.
Early postoperative recovery was evaluated using recovery time and the Modified Aldrete Score. Postoperative sore throat, dysphagia, cough, and hoarseness were assessed in the post-anesthesia care unit and at 2, 8, 12, and 24 hours after surgery. Although 24-hour follow-up was planned, complete data were available for only 24 of the 64 patients. Therefore, comparative analyses of postoperative airway morbidity were restricted to assessments through 12 hours.
Airway complications, including laryngospasm and bronchospasm, were also recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VLMA Group | – | Device: Video Laryngeal Mask Airway (VLMA)The proximal glottic region was evaluated using the device's integrated camera. Distal tracheal blood contamination was assessed using flexible bronchoscopy in all patients in this cohort, regardless of the presence or absence of proximal blood contamination. |
| ETT Group | – | Device: Endotracheal Tube (ETT)Participants whose airway was managed with a conventional endotracheal tube (ETT) inserted using direct laryngoscopy during routine clinical practice were included in this cohort. At the end of surgery, the distal trachea was examined using flexible bronchoscopy through the ETT before removal. Proximal tracheal/glottic contamination was assessed indirectly by examining blood around the distal portion of the ETT cuff after aspiration of the posterior oropharynx and extubation. Perioperative hemodynamic and ventilation parameters, airway placement characteristics, recovery outcomes, and postoperative airway morbidity were recorded. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study included adult patients aged 18-65 years with ASA physical status I-II who underwent elective septoplasty under general anesthesia. Patients were classified into the VLMA or ETT cohort according to the airway device selected by the responsible anesthesiologist during routine clinical practice. No randomization was performed. Patients with an anticipated difficult airway, body mass index greater than 30 kg/m², gastroesophageal reflux disease or hiatal hernia, or pregnancy were excluded.
Key inclusion criteria (3 listed)
- Patients aged 18-65 years
- ASA physical status I-II
- Patients scheduled for elective septoplasty under general anesthesia
Key exclusion criteria (5 listed)
- Anticipated difficult airway
- ASA physical status III-IV
- History of gastroesophageal reflux disease or hiatal hernia
- Body mass index greater than 30 kg/m²
- Pregnancy
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 |
|---|---|---|
| Video Laryngeal Mask Airway (VLMA)The SaCoVLM™ video laryngeal mask airway, a supraglottic airway device with an integrated camera, was used for airway management during elective septoplasty. The integrated camera enabled direct visualization of the glottic inlet and assessment of proximal blood contamination. At the end of surgery, distal tracheal blood contamination was assessed using flexible bronchoscopy in all 32 VLMA patients included in the final analysis, regardless of proximal blood contamination findings. Airway insertion characteristics, ventilation and hemodynamic parameters, recovery outcomes, and postoperative airway morbidity were recorded. | Device | VLMA Group |
| Endotracheal Tube (ETT)A conventional cuffed endotracheal tube was inserted using direct laryngoscopy for airway management during elective septoplasty. At the end of surgery, the distal trachea was examined for blood contamination using flexible bronchoscopy through the ETT before removal. Proximal tracheal/glottic contamination was assessed indirectly by examining blood around the distal portion of the ETT cuff after aspiration of the posterior oropharynx and extubation. Airway insertion characteristics, ventilation and hemodynamic parameters, recovery outcomes, and postoperative airway morbidity were recorded. | Device | ETT Group |
Primary outcome
Proximal Tracheal/Glottic and Distal Tracheal Blood Contamination Scores
Time frame: At the end of surgery, immediately before and after airway device removal.
Airway blood contamination was assessed at the end of surgery using a four-point ordinal scale: 1 = no blood, 2 = mild, 3 = moderate, and 4 = severe contamination. Higher scores indicated greater contamination. In the VLMA group, proximal blood was assessed directly using the integrated camera. In the ETT group, proximal blood was assessed indirectly by inspecting blood around the ETT cuff after oropharyngeal suctioning and extubation. The proximal assessment methods were not equivalent. Distal tracheal blood contamination was assessed by flexible bronchoscopy in all 64 patients (32 per group), regardless of proximal findings. Scores were recorded separately for each anatomical level and summarized by the number and percentage of participants in each category. No total score was calculated.
10 secondary outcomes
Heart Rate (HR)
Time frame: From preoperative baseline to 5 minutes after airway device removal.
Postoperative Sore Throat (POST Score)
Time frame: From the post-anesthesia care unit through 24 hours postoperatively (assessments at recovery, 2, 8, 12, and 24 hours).
Arterial Blood Pressure
Time frame: From preoperative baseline to 5 minutes after airway device removal.
Airway Insertion Time
Time frame: Assessed once during airway device placement, immediately after anesthesia induction.
Intraoperative and Early Postoperative Airway Complications
Time frame: From anesthesia induction through the early postoperative period in the post-anesthesia care unit.
Postoperative Dysphagia
Time frame: From the post-anesthesia care unit through 24 hours postoperatively (assessments at recovery, 2, 8, 12, and 24 hours).
First-Attempt Success Rate of Airway Device Insertion
Time frame: Assessed once during airway device placement immediately after anesthesia induction.
Postoperative Cough
Time frame: During recovery and at 2, 8, 12, and 24 hours postoperatively.
Postoperative Hoarseness
Time frame: During recovery and at 2, 8, 12, and 24 hours postoperatively.
Surgeon Satisfaction With Surgical Conditions
Time frame: At the end of surgery (single assessment).
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 22 Oct 2026.
- Background: PubMed 15064618Kaplan A, Crosby GJ, Bhattacharyya N. Airway protection and the laryngeal mask airway in sinus and nasal surgery. Laryngoscope. 2004 Apr;114(4):652-5. doi: 10.1097/00005537-200404000-00010.
- Background: PubMed 33407130Karaaslan E, Akbas S, Ozkan AS, Colak C, Begec Z. A comparison of laryngeal mask airway-supreme and endotracheal tube use with respect to airway protection in patients undergoing septoplasty: a randomized, single-blind, controlled clinical trial. BMC Anesthesiol. 2021 Jan 7;21(1):5. doi: 10.1186/s12871-020-01222-4.
- Relevant study comparing LMA and ETT in septoplasty (Karasalan et al., BMC Anesthesiol 2021)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Hatice Selcuk KUSDERCI, M.D. study director
Samsun 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 Airway Complication of Anesthesia and Septoplasty, run by Samsun 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 3 inclusion and 5 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 22 Oct 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?
Proximal Tracheal/Glottic and Distal Tracheal Blood Contamination Scores (time frame: At the end of surgery, immediately before and after airway device removal.). 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 NCT06950957, which also lists 2 linked publications.
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 22 Oct 2026.