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Clinical Trials/NCT03903679
NCT03903679CompletedNot Applicable

Is Endotracheal Tube Use Mandatory in Patients Undergoing Nasal Septum Surgery? Randomized, Controlled, Prospective Clinical Trial

Inonu University1 site in 1 country80 target enrollmentStarted: April 5, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
1
Primary Endpoint
Presence of blood in trachea

Study Overview

Brief Summary

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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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,

Arms & Interventions

Laryngeal mask airway

Active Comparator

Patients will be maintained with laryngeal mask airway supreme during the septal surgery.

Intervention: Laryngeal mask airway (Device)

Endotracheal tube

Sham Comparator

Patients will be maintained with endotracheal tube during the septal surgery.

Intervention: Endotracheal tube (Device)

Outcomes

Primary Outcomes

Presence of blood in trachea

Time Frame: From the time 2minutes after the septal surgery to the time of extubation

Presence of blood in trachea will be evaluated on a scale and it is defined as the level of presence of blood on glottis-trachea and distal trachea. (1 = no, 2 = mild, 3 = moderate, 4 = severe).

Secondary Outcomes

  • Sore-throat(From the time 10 minutes after awakening from anesthesia to the time 24 hours postoperatively)
  • Oropharyngeal leak pressure(From the time 2 minutes after anesthesia induction to the correction of inserted device 5 minutes after anesthesia induction)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Erol Karaaslan

Asst. Prof. Erol Karaaslan

Inonu University

Study Sites (1)

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