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

NCT ID: NCT03903679

Last Updated: 2019-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-05
• Study Completion Date: 2019-06-08

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.

Conditions

Airway Aspiration; Airway Complication of Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Laryngeal mask airway

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

Group Type: ACTIVE_COMPARATOR

Laryngeal mask airway

Intervention Type: DEVICE

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

Endotracheal tube

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

Group Type: SHAM_COMPARATOR

Endotracheal tube

Intervention Type: DEVICE

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

Interventions

Laryngeal mask airway

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

Intervention Type: DEVICE

Endotracheal tube

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

Intervention Type: DEVICE

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

Erol Karaaslan

Asst. Prof. Erol Karaaslan

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erol Karaaslan, Asst. Prof.

Role: PRINCIPAL_INVESTIGATOR

Inonu University Medical Faculty

Locations

Inonu University Medical Faculty

Malatya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 30069317 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33407130 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

erolkaraaslan2

Identifier Type: -

Identifier Source: org_study_id