Clinical trial NCT03903679: Is Endotracheal Tube Use Mandatory in Patients Undergoing Nasal Septum Surgery?
Official title: Is Endotracheal Tube Use Mandatory in Patients Undergoing Nasal Septum Surgery? Randomized, Controlled, Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Aspiration
Airway Complication of Anesthesia
Keywords: Airway management
Septal surgery
Laryngeal mask airway
Endotracheal tube
Presence of tracheal blood
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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,

Primary outcomes:
measure: Presence of blood in trachea
timeFrame: From the time 2minutes after the septal surgery to the time of extubation
Secondary outcomes:
measure: Sore-throat
timeFrame: From the time 10 minutes after awakening from anesthesia to the time 24 hours postoperatively
measure: Oropharyngeal leak pressure
timeFrame: From the time 2 minutes after anesthesia induction to the correction of inserted device 5 minutes after anesthesia induction
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University Medical Faculty
Study officials:
affiliation: Inonu University Medical Faculty
name: Erol Karaaslan, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mao S, Du X, Ma J, Zhang G, Cui J. A comparison between laryngeal mask airway and endotracheal intubation for anaesthesia in adult patients undergoing NUSS procedure. J Thorac Dis. 2018 Jun;10(6):3216-3224. doi: 10.21037/jtd.2018.05.74.
citation: Karaaslan E, Akbas S, Ozkan AS, Colak C, Begec Z. 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. BMC Anesthesiol. 2021 Jan 7;21(1):5. doi: 10.1186/s12871-020-01222-4.