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

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

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 Overview

• Status: Completed
• Conditions: Airway Complication of Anesthesia; Airway Aspiration
• Intervention / Treatment: Device: Laryngeal mask airway; Device: Endotracheal tube

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Malatya, Turkey, 44090
    • Inonu University Medical Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laryngeal mask airway; Patients will be maintained with laryngeal mask airway supreme during the septal surgery.	Device: Laryngeal mask airway; Patients will be maintained with laryngeal mask airway during the septal surgery.
Sham Comparator: Endotracheal tube; Patients will be maintained with endotracheal tube during the septal surgery.	Device: Endotracheal tube; Patients will be maintained with endotracheal tube during the septal surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of blood in trachea	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).	From the time 2minutes after the septal surgery to the time of extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sore-throat	Sore-throat is defined as constant pain felt independently of swallowing. The evaluation was made with 0 ile10 numerical pain rating scale. According to numerical pain rating scale, sore throat score was evaluated as; 0-1 none, 2-4 between mild, 5-7 intermediate and 8-10 severe N	From the time 10 minutes after awakening from anesthesia to the time 24 hours postoperatively
Oropharyngeal leak pressure	Oropharyngeal leak pressures were measured while the head was in neutral position. The flowmeter oxygen current was set at 3 L/min and the expiratory valve was closed. When an investigator who did not know which type of airway device was placed, another researcher looked at the current pressure value from the aneroid manometer and confirmed that the pressure remained constant (pressure gauge stability test). This value was recorded as the value of Oropharyngeal leakage pressure. To prevent lung exposure to barotrauma, the expiratory valve was opened when the peak inspiratory pressure reached 40 pressure, and the test was terminated.	From the time 2 minutes after anesthesia induction to the correction of inserted device 5 minutes after anesthesia induction

Collaborators and Investigators

• Sponsor: Inonu University
• Investigators: Principal Investigator: Erol Karaaslan, Asst. Prof., Inonu University Medical Faculty

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2019
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 8, 2019

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 23, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Endotracheal tube; Airway management; Septal surgery; Laryngeal mask airway; Presence of tracheal blood
• Other Study ID Numbers: erolkaraaslan2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No