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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laryngeal mask airway group | Experimental | Flexible laryngeal mask airway is inserted for general anesthesia |
|
| intubation group | Active Comparator | Endotracheal intubation was performed for general anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laryngeal mask airway | Device | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JongYeop Kim, M.D.,Ph.D. | Ajou University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University Hospital | Suwon | Gyeongki-do | 443-721 | South Korea |
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| ID | Term |
|---|---|
| D017214 | Laryngeal Masks |
| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
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|
| Endotracheal tube | Device | Endotracheal tube is a plain tube, which is most commonly used in general anesthesia. |
|
|
| 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 |
| D008919 |
| Investigative Techniques |
| D008397 | Masks |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |