Flexible Laryngeal Mask Airway Versus Tracheal Intubation in Nasal Bone Fracture

Laryngeal Mask Airway Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04520555
• Other study ID #: AJIRB-MED-OBS-20-081
• Status: Completed
• Phase: N/A
• Start date: July 13, 2020
• Est. completion date: January 27, 2022

Study information

• Verified date: July 2022
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 27, 2022
• Est. primary completion date: January 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Laryngeal Mask Airway

Intervention

Device:
• Laryngeal 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
• Endotracheal tube
Endotracheal tube is a plain tube, which is most commonly used in general anesthesia.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon	Gyeongki-do

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adequate tidal volume during mechanical ventilation	Tidal volume (ml)	From insertion of airway device to extubation
Secondary	Adequate ventilation during mechanical ventilation	end-tidal carbon dioxide	From insertion of airway device to extubation
Secondary	Airway pressure during mechanical ventilation	peak and mean airway pressure	From insertion of airway device to extubation
Secondary	Changes of heart rate	Heart rate	Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.
Secondary	Changes of blood pressure	mean blood pressure	Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.
Secondary	Changes of saturation	peripheral saturation	Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Participants with postoperative airway complications	Sore throat, hoarseness, dysphagia, and nausea and vomiting	30 minutes after surgery and postoperative 1 day