Laryngeal Mask Airway
Conditions
Keywords
Laryngeal mask airway, Intubation, nasal bone fracture, recovery
Brief summary
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.
Interventions
DEVICELaryngeal mask airway
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
DEVICEEndotracheal tube
Endotracheal tube is a plain tube, which is most commonly used in general anesthesia.
Sponsors
Ajou University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cough during extubation | From end of surgery to 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adequate tidal volume during mechanical ventilation | From insertion of airway device to extubation | Tidal volume (ml) |
| Adequate ventilation during mechanical ventilation | From insertion of airway device to extubation | end-tidal carbon dioxide |
| Airway pressure during mechanical ventilation | From insertion of airway device to extubation | peak and mean airway pressure |
| Changes of heart rate | Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation. | Heart rate |
| Changes of blood pressure | Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation. | mean blood pressure |
| Changes of saturation | Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation. | peripheral saturation |
| Number of Participants with blood contamination at vocal cord and distal trachea | Between the end of surgery and extubation | Blood contamination was examined using fibrobronchoscope. |
| Device blood contamination | At airway device removal | 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 |
| Number of Participants with airway complications after extubation | From extubation to 5 minutes after extubation | laryngospasm, hypoventilation (respiratory rate \<8/minutes), desaturation (peripheral pulse oximetry saturation \<95%) |
| Time to eye opening and time to extubation | From anesthetic discontinuation to eye opening and extubation | Time in seconds from anesthetic discontinuation to eye opening at verbal commend and time in seconds from anesthetic discontinuation to extubation |
| Number of Participants with postoperative airway complications | 30 minutes after surgery and postoperative 1 day | Sore throat, hoarseness, dysphagia, and nausea and vomiting |
Countries
South Korea
Outcome results
None listed