Clinical trial NCT04520555: 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
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Mask Airway
Keywords: Laryngeal mask airway
Intubation
nasal bone fracture
recovery
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: cough during extubation
timeFrame: From end of surgery to extubation
Secondary outcomes:
measure: Adequate tidal volume during mechanical ventilation
timeFrame: From insertion of airway device to extubation
measure: Adequate ventilation during mechanical ventilation
timeFrame: From insertion of airway device to extubation
measure: Airway pressure during mechanical ventilation
timeFrame: From insertion of airway device to extubation
measure: Changes of heart rate
timeFrame: Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.
measure: Changes of blood pressure
timeFrame: Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.
measure: Changes of saturation
timeFrame: Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.
measure: Number of Participants with blood contamination at vocal cord and distal trachea
timeFrame: Between the end of surgery and extubation
measure: Device blood contamination
timeFrame: At airway device removal
measure: Number of Participants with airway complications after extubation
timeFrame: From extubation to 5 minutes after extubation
measure: Time to eye opening and time to extubation
timeFrame: From anesthetic discontinuation to eye opening and extubation
measure: Number of Participants with postoperative airway complications
timeFrame: 30 minutes after surgery and postoperative 1 day
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeongki-do
Study officials:
affiliation: Ajou University School of Medicine
name: JongYeop Kim, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: