Flexible Laryngeal Mask Airway Versus Tracheal Intubation in Nasal Bone Fracture

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

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.

Study Overview

• Status: Completed
• Conditions: Laryngeal Mask Airway
• Intervention / Treatment: Device: Laryngeal mask airway; Device: Endotracheal tube

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeongki-do
    • Suwon, Gyeongki-do, Korea, Republic of, 443-721
      • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Laryngeal mask airway group; Flexible laryngeal mask airway is inserted for general anesthesia	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; Other Names: LMA Flexible,Teleflex Co., Westmeath, Ireland
ACTIVE_COMPARATOR: intubation group; Endotracheal intubation was performed for general anesthesia	Device: Endotracheal tube; Endotracheal tube is a plain tube, which is most commonly used in general anesthesia.; Other Names: Portex, Smiths Medical International Ltd., South East England, United Kingdom

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 13, 2020
• Primary Completion (ACTUAL): January 26, 2022
• Study Completion (ACTUAL): January 27, 2022

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (ACTUAL): August 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: recovery; Intubation; Laryngeal mask airway; nasal bone fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: AJIRB-MED-OBS-20-081

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No