Actively Recruiting

Age: 18Years - 65Years
All Genders
ID06950957

Comparison of Video Laryngeal Mask Airway and Endotracheal Tube Use for Airway Safety in Patients Undergoing Septoplasty

Led by Samsun University · Updated on 2025-06-12

64

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Video Laryngeal Mask vs. Endotracheal Tube in Septoplasty

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ASA I-II classification patients
  • Patients aged 18-65 years undergoing elective septoplasty
Not Eligible

You will not qualify if you...

  • 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
  • Body mass index (BMI) >30
  • Pregnant patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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)

Trial Site Locations

Total: 1 location

1

Samsun University, Samsun Training and Research Hospital

Samsun, Ilkadim, Turkey (Türkiye), 55000

Actively Recruiting

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Research Team

H

Hatice Selcuk KUSDERCI, M.D.

A

Ahmet Ozan Aydin, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

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.

Erol Karaaslan, Sedat Akbas, Ahmet Selim Ozkan...

https://pubmed.ncbi.nlm.nih.gov/33407130