Back to resultsFlexible Laryngeal Mask Airway Versus Tracheal Intubation in Nasal Bone Fracture
Primary Purpose
Laryngeal Mask Airway
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Laryngeal mask airway
Endotracheal tube
Sponsored by
About this trial
This is an interventional treatment trial for Laryngeal Mask Airway focused on measuring Laryngeal mask airway, Intubation, nasal bone fracture, recovery
Eligibility Criteria
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
Sites / Locations
- Ajou University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laryngeal mask airway group
intubation group
Arm Description
Flexible laryngeal mask airway is inserted for general anesthesia
Endotracheal intubation was performed for general anesthesia
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Adequate tidal volume during mechanical ventilation
Tidal volume (ml)
Adequate ventilation during mechanical ventilation
end-tidal carbon dioxide
Airway pressure during mechanical ventilation
peak and mean airway pressure
Changes of heart rate
Heart rate
Changes of blood pressure
mean blood pressure
Changes of saturation
peripheral saturation
Number of Participants with blood contamination at vocal cord and distal trachea
Blood contamination was examined using fibrobronchoscope.
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
Number of Participants with airway complications after extubation
laryngospasm, hypoventilation (respiratory rate <8/minutes), desaturation (peripheral pulse oximetry saturation <95%)
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
Number of Participants with postoperative airway complications
Sore throat, hoarseness, dysphagia, and nausea and vomiting
Full Information
NCT ID
NCT04520555
First Posted
August 12, 2020
Last Updated
July 18, 2022
Sponsor
Ajou University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04520555
Brief Title
Flexible Laryngeal Mask Airway Versus Tracheal Intubation in Nasal Bone Fracture
Official Title
Comparison of Recovery Profiles Between Flexible Laryngeal Mask Airway and Tracheal Intubation in Nasal Bone Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 13, 2020 (Actual)
Primary Completion Date
January 26, 2022 (Actual)
Study Completion Date
January 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Mask Airway
Keywords
Laryngeal mask airway, Intubation, nasal bone fracture, recovery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laryngeal mask airway group
Arm Type
Experimental
Arm Description
Flexible laryngeal mask airway is inserted for general anesthesia
Arm Title
intubation group
Arm Type
Active Comparator
Arm Description
Endotracheal intubation was performed for general anesthesia
Intervention Type
Device
Intervention Name(s)
Laryngeal mask airway
Other Intervention Name(s)
LMA Flexible,Teleflex Co., Westmeath, Ireland
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Endotracheal tube
Other Intervention Name(s)
Portex, Smiths Medical International Ltd., South East England, United Kingdom
Intervention Description
Endotracheal tube is a plain tube, which is most commonly used in general anesthesia.
Primary Outcome Measure Information:
Title
cough during extubation
Description
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)
Time Frame
From end of surgery to extubation
Secondary Outcome Measure Information:
Title
Adequate tidal volume during mechanical ventilation
Description
Tidal volume (ml)
Time Frame
From insertion of airway device to extubation
Title
Adequate ventilation during mechanical ventilation
Description
end-tidal carbon dioxide
Time Frame
From insertion of airway device to extubation
Title
Airway pressure during mechanical ventilation
Description
peak and mean airway pressure
Time Frame
From insertion of airway device to extubation
Title
Changes of heart rate
Description
Heart rate
Time Frame
Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.
Title
Changes of blood pressure
Description
mean blood pressure
Time Frame
Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.
Title
Changes of saturation
Description
peripheral saturation
Time Frame
Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.
Title
Number of Participants with blood contamination at vocal cord and distal trachea
Description
Blood contamination was examined using fibrobronchoscope.
Time Frame
Between the end of surgery and extubation
Title
Device blood contamination
Description
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
Time Frame
At airway device removal
Title
Number of Participants with airway complications after extubation
Description
laryngospasm, hypoventilation (respiratory rate <8/minutes), desaturation (peripheral pulse oximetry saturation <95%)
Time Frame
From extubation to 5 minutes after extubation
Title
Time to eye opening and time to extubation
Description
Time in seconds from anesthetic discontinuation to eye opening at verbal commend and time in seconds from anesthetic discontinuation to extubation
Time Frame
From anesthetic discontinuation to eye opening and extubation
Title
Number of Participants with postoperative airway complications
Description
Sore throat, hoarseness, dysphagia, and nausea and vomiting
Time Frame
30 minutes after surgery and postoperative 1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JongYeop Kim, M.D.,Ph.D.
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeongki-do
ZIP/Postal Code
443-721
Country
Korea, Republic of
12. IPD Sharing Statement
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Flexible Laryngeal Mask Airway Versus Tracheal Intubation in Nasal Bone Fracture
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