Video Laryngeal Mask vs. Endotracheal Tube in Septoplasty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorSamsun University
About this trial
This randomized controlled trial compares a video laryngeal mask airway (VLMA) and an endotracheal tube (ETT) in adult patients undergoing elective septoplasty. The primary objective is to see which device more effectively prevents surgical blood contamination in the glottic and subglottic regions. The study also assesses perioperative hemodynamic stability, ventilation parameters, and postoperative recovery factors such as sore throat, hoarseness, and overall patient comfort. The findings aim to help determine the optimal airway device choice for nasal surgeries.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ASA I-II classification patients
Patients aged 18-65 years undergoing elective septoplasty
Disqualifiers
ASA III-IV classification patients
Patients with anticipated difficult airway
Patients under 18 years of age
History of gastroesophageal reflux disease (GERD) or hiatal hernia
Trial population
This study includes adult patients (aged 18-65 years) undergoing elective septoplasty under general anesthesia. Participants are classified as ASA I-II and are randomly assigned to the VLMA or ETT groups. Patients with anticipated difficult airway, high BMI (\>30), GERD, or pregnancy are excluded
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Video Laryngeal Mask Airway (VLMA)
DeviceA second-generation supraglottic airway device with an integrated video camera, used for airway management in adult patients undergoing elective septoplasty. The device allows real-time visualization of the glottic inlet to identify blood infiltration or anatomical challenges. Prior to removal, a fiberoptic bronchoscope will be introduced through the device's lumen to assess the distal trachea for blood contamination. Parameters such as airway insertion time, ventilation mechanics, hemodynamic data, analgesic requirements, and postoperative recovery scores (e.g., Aldrete score, sore throat incidence) will be recorded and analyzed.
Endotracheal Tube (ETT)
DeviceA standard cuffed endotracheal tube inserted using direct laryngoscopy, employed for airway management during elective septoplasty. At the end of surgery, a fiberoptic bronchoscope will be passed through the ETT to evaluate the distal trachea for blood contamination. Airway insertion time, ventilation parameters, intraoperative hemodynamics, analgesic use, and postoperative outcomes (including sore throat and recovery scores) will be documented and compared with the VLMA group to assess differences in airway safety and clinical performance.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: VLMA Group1 intervention
Group B: ETT Group1 intervention
Trial outcomes
Primary outcomes
1
Glottis/Trachea and Distal Trachea Blood Contamination Scores
The presence of blood contamination will be evaluated separately at two distinct airway sites: Distal trachea: Both SaCoVLM and ETT groups will undergo fiberoptic bronchoscopic evaluation for blood contamination in the distal trachea immediately before removal of the airway device at the end of surgery. Glottis/tracheal inlet: This area will be visually assessed only in the SaCoVLM group using the integrated camera of the video laryngeal mask immediately prior to device removal at the end of surgery. A standardized 4-point scale will be used for both assessments: 1. = No blood contamination 2. = Mild amount of blood contamination (trace amounts) 3. = Moderate amount of blood contamination 4. = Severe amount of blood contamination
Time frame
Evaluated once at the conclusion of surgery, immediately prior to device removal (approximately 60-120 minutes after anesthesia induction).Secondary outcomes
1
Heart Rate (HR)
Heart rate (beats per minute) will be recorded at the following time points: pre-operative baseline; immediately after induction of anesthesia; at 1, 3, 5, 10, 15, and 30 minutes after airway-device insertion; and at 5 minutes after extubation.
Time frame
From preoperative baseline until arrival to the recovery unit (approximately 120 minutes).2
Postoperative Sore Throat (POST Score)
he severity of postoperative sore throat (POST) will be assessed using a standardized scoring system immediately after extubation, upon arrival to the recovery room, and at 2, 8, 12, 24, and 48 hours postoperatively. The score is based on patient-reported discomfort and classified as follows: 0: No sore throat 1. Mild discomfort (less than a common cold) 2. Moderate discomfort (as bad as a common cold) 3. Severe discomfort interfering with daily activities The assessment will be conducted through direct patient questioning at each designated time point.
Time frame
Up to 48 hours postoperatively.3
Arterial Blood Pressure (Systolic, Diastolic, and Mean)
Systolic, diastolic, and mean arterial blood pressures (mmHg) will be recorded at the following time points: pre-operative baseline; immediately after induction of anesthesia; at 1, 3, 5, 10, 15, and 30 minutes after airway-device insertion; and at 5 minutes after extubation.
Time frame
From preoperative baseline until arrival to the recovery unit (approximately 120 minutes).4
Total Remifentanil Consumption
Total remifentanil dose (mcg) administered during surgery will be compared between groups.
Time frame
IntraoperativeSponsors and contacts
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Source ClinicalTrials.gov