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Is Endotracheal Tube Use Mandatory in Patients Undergoing Nasal Septum Surgery? (LMA)

I

Inonu University

Status

Completed

Conditions

Airway Complication of Anesthesia
Airway Aspiration

Treatments

Device: Endotracheal tube
Device: Laryngeal mask airway

Study type

Interventional

Funder types

Other

Identifiers

NCT03903679
erolkaraaslan2

Details and patient eligibility

About

The efficacy of supraglottic airway device use in many surgeries has been shown. Due to concerns such as tracheal blood leakage and vocal cord contamination in nasal septum surgery, there are doubts about the use of laryngeal mask airway among anesthesiologists.

The primary purpose of this study is; the aim of this study was to evaluate the tracheal blood leak with a flexible fiberoptic endoscope in patients who underwent nasal septum surgery and continued airway patency via laryngeal mask airway or endotracheal tube. Secondly, oropharyngeal leak pressure, hemodynamic response, airway reflexes (laryngospasm, bronchospasm, cough, desaturation), postoperative nausea, vomiting, sore throat, hoarseness and difficulty in swallowing will be evaluated.

Full description

Airway management is one of the main issue of anesthesia practice. The use of endotracheal tubes has been accepted as the standard method for many years. High pressure and long-term use of cuffed tubes related to mucosal hypoperfusion and submucosal stenosis are important. The laryngeal mask airway is produced in the 1980s and considered as a supraglottic airway used to provide airway clearance in short-term surgical procedures. The laryngeal mask airways have recently found to use in many general anesthesia applications as a minimally invasive airway method and continue to be used increasingly. More appropriate supraglottic airway vehicles with different characteristics in terms of efficacy and side effects are being developed.

Laryngeal mask airway-Supreme™ is latex-free, semi-rigid, elliptical and anatomical shape due to the fingers in the mouth of the patient easily and quickly without inserting the new generation laryngeal mask airways. Designed to provide higher sealing pressures than the laryngeal mask airway-classic. In addition, the presence of a gastric canal for gastric tube passage is another important advantage.

The efficacy of supraglottic airway device use in many surgeries has been shown. Due to concerns such as tracheal blood leakage and vocal cord contamination in nasal septum surgery, there are doubts about the use of laryngeal mask airway among anesthesiologists.

The primary purpose of this study is; the aim of this study was to evaluate the tracheal blood leak with a flexible fiberoptic endoscope in patients who underwent nasal septum surgery and continued airway patency via laryngeal mask airway or endotracheal tube. Secondly, oropharyngeal leak pressure, hemodynamic response, airway reflexes (laryngospasm, bronchospasm, cough, desaturation), postoperative nausea, vomiting, sore throat, hoarseness and difficulty in swallowing will be evaluated.

Enrollment

80 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18-65 years old,
  • American Society of Anesthesiologists I-II
  • Patients with elective nasal septum surgery.
  • Patients who agreed to participate with informed consent form.

Exclusion criteria

  • Under 18 years,
  • Over 65 years,
  • American Society of Anesthesiologists III-IV,
  • Patients with severe respiratory, hepatic or renal dysfunction,
  • Patients with history of allergy to anesthesia medications
  • Modified mallampati grade 4,
  • Thyromental distance <65 mm,

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Laryngeal mask airway
Active Comparator group
Description:
Patients will be maintained with laryngeal mask airway supreme during the septal surgery.
Treatment:
Device: Laryngeal mask airway
Endotracheal tube
Sham Comparator group
Description:
Patients will be maintained with endotracheal tube during the septal surgery.
Treatment:
Device: Endotracheal tube

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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