Flexible Laryngeal Mask Airway Versus Tracheal Intubation in Nasal Bone Fracture

Study Overview
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Brief Summary
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In surgery under general anesthesia due to nasal bone fracture, laryngeal mask airway or tracheal intubation has been used. However, it has not been investigated that the difference of recovery profiles according to use of laryngeal mask airway or tracheal intubation in nasal bone fracture surgery. The aim of study is to evaluate the efficacy of the laryngeal mask airway regarding recovery profiles and airway complications, compared to tracheal intubation.

Official Title
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Comparison of Recovery Profiles Between Flexible Laryngeal Mask Airway and Tracheal Intubation in Nasal Bone Fracture

Conditions
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Laryngeal Mask Airway

Intervention / Treatment
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* Device: Laryngeal mask airway
* Device: Endotracheal tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with American Society of Anesthesiologists classification 1 or 2 who receive general anesthesia due to nasal bone fracture Exclusion Criteria: Patients with high risk of aspiration, patients who anticipated difficult airway

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laryngeal mask airway group<br>Flexible laryngeal mask airway is inserted for general anesthesia | Device: Laryngeal mask airway<br>* LMA Flexible is a supraglottic airway device, which can be moved out of the surgical field without displacement of the cuff, or loss of seal for the anesthetist<br>* Other names: LMA Flexible,Teleflex Co., Westmeath, Ireland;|
| Active Comparator: intubation group<br>Endotracheal intubation was performed for general anesthesia | Device: Endotracheal tube<br>* Endotracheal tube is a plain tube, which is most commonly used in general anesthesia.<br>* Other names: Portex, Smiths Medical International Ltd., South East England, United Kingdom;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cough during extubation | Grade of cough during periextubation periods (0=no cough, 1=single cough, 2=more than one episode of non-sustained cough, 3=sustained and repetitive cough with head lift) | From end of surgery to extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate tidal volume during mechanical ventilation | Tidal volume (ml) | From insertion of airway device to extubation | 
| Adequate ventilation during mechanical ventilation | end-tidal carbon dioxide | From insertion of airway device to extubation | 
| Airway pressure during mechanical ventilation | peak and mean airway pressure | From insertion of airway device to extubation | 
| Changes of heart rate | Heart rate | Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation. | 
| Changes of blood pressure | mean blood pressure | Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation. | 
| Changes of saturation | peripheral saturation | Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation. | 
| Number of Participants with blood contamination at vocal cord and distal trachea | Blood contamination was examined using fibrobronchoscope. | Between the end of surgery and extubation | 
| Device blood contamination | 0=no contamination, 1=external contamination of the tube, 2=some soilage of the inner surface of the tube, 3=frank coating of the inner surface of the tube | At airway device removal | 
| Number of Participants with airway complications after extubation | laryngospasm, hypoventilation (respiratory rate <8/minutes), desaturation (peripheral pulse oximetry saturation <95%) | From extubation to 5 minutes after extubation | 
| Time to eye opening and time to extubation | Time in seconds from anesthetic discontinuation to eye opening at verbal commend and time in seconds from anesthetic discontinuation to extubation | From anesthetic discontinuation to eye opening and extubation | 
| Number of Participants with postoperative airway complications | Sore throat, hoarseness, dysphagia, and nausea and vomiting | 30 minutes after surgery and postoperative 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngeal mask airway, Intubation, nasal bone fracture, recovery