Airway protection and the laryngeal mask airway in sinus and nasal surgery.
Andrew Kaplan, Gregory J Crosby, Neil Bhattacharyya
https://pubmed.ncbi.nlm.nih.gov/15064618Actively Recruiting
Led by Samsun University · Updated on 2025-06-12
64
Participants Needed
1
Research Sites
4 weeks
Total Duration
Researchers are comparing two airway devices, a video laryngeal mask airway (VLMA) and a standard endotracheal tube (ETT), in adults aged 18 to 65 undergoing elective septoplasty surgery. The main goal is to see which device better prevents blood contamination in the airway during surgery. The study also evaluates heart rate, blood pressure, ventilation, and recovery factors like sore throat and comfort after surgery to find the best airway device for nasal procedures. Participants will be randomly assigned to one of two groups: one using the VLMA with a built-in camera for direct visualization of the airway, and the other using the standard ETT inserted with direct laryngoscopy. Both groups will have blood contamination assessed in the distal trachea using a fiberoptic bronchoscope before device removal. The VLMA group has the added advantage of video inspection of the glottic area. All participants will receive standard anesthesia care with drugs like propofol and remifentanil, and monitoring will include anesthesia depth and respiratory and hemodynamic parameters. During and after surgery, researchers will record ventilation data, heart rate, blood pressure, anesthesia and surgical duration, airway insertion success, and any airway complications. After surgery, patients will be monitored until fully recovered, and symptoms such as sore throat, hoarseness, swallowing difficulties, cough, nausea, and airway spasms will be assessed at multiple time points up to 48 hours. This detailed monitoring will help determine which device offers better airway protection, stability, and patient comfort during septoplasty.
CONDITIONS
Video Laryngeal Mask vs. Endotracheal Tube in Septoplasty
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 hours (including anesthesia and surgery)
Participants undergo elective septoplasty surgery with airway management using either a video laryngeal mask airway (VLMA) or an endotracheal tube (ETT). During surgery, airway insertion time, ventilation metrics, hemodynamic data, and airway complications are monitored. Blood contamination in the airway is assessed immediately before device removal using a fiberoptic bronchoscope, and for the VLMA group, also with the device's integrated camera. After surgery, participants are monitored in the post-anesthesia care unit until they achieve an acceptable recovery score.
1 surgical visit (in-person) and transfer to post-anesthesia care unit
Duration - Up to 48 hours after surgery
Participants are assessed for airway-related symptoms such as sore throat, hoarseness, dysphagia, cough, nausea, vomiting, and respiratory complications at multiple time points after surgery. Monitoring occurs at 2, 8, 12, 24, and 48 hours postoperatively to evaluate recovery and any adverse events.
5 follow-up assessments (in-person or remote)
Total: 1 location
1
Samsun University, Samsun Training and Research Hospital
Samsun, Ilkadim, Turkey (Türkiye), 55000
Actively Recruiting
H
Hatice Selcuk KUSDERCI, M.D.
A
Ahmet Ozan Aydin, M.D.
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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