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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903679
Recruitment Status : Completed
First Posted : April 4, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Erol Karaaslan, Inonu University

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.


Condition or disease Intervention/treatment Phase
Airway Aspiration Airway Complication of Anesthesia Device: Laryngeal mask airway Device: Endotracheal tube Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Is Endotracheal Tube Use Mandatory in Patients Undergoing Nasal Septum Surgery? Randomized, Controlled, Prospective Clinical Trial
Actual Study Start Date : April 5, 2019
Actual Primary Completion Date : June 1, 2019
Actual Study Completion Date : June 8, 2019

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Sore-throat [ Time Frame: From the time 10 minutes after awakening from anesthesia to the time 24 hours postoperatively ]
    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

  2. Oropharyngeal leak pressure [ Time Frame: From the time 2 minutes after anesthesia induction to the correction of inserted device 5 minutes after anesthesia induction ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903679


Locations
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Turkey
Inonu University Medical Faculty
Malatya, Turkey, 44090
Sponsors and Collaborators
Inonu University
Investigators
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Principal Investigator: Erol Karaaslan, Asst. Prof. Inonu University Medical Faculty
  Study Documents (Full-Text)

Documents provided by Erol Karaaslan, Inonu University:
Publications:
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Responsible Party: Erol Karaaslan, Asst. Prof. Erol Karaaslan, Inonu University
ClinicalTrials.gov Identifier: NCT03903679    
Other Study ID Numbers: erolkaraaslan2
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erol Karaaslan, Inonu University:
Airway management
Septal surgery
Laryngeal mask airway
Endotracheal tube
Presence of tracheal blood