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Clinical Trials/NCT04520555
NCT04520555CompletedNot Applicable

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

Ajou University School of Medicine2 sites in 1 country70 target enrollmentStarted: July 13, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
70
Locations
2
Primary Endpoint
cough during extubation
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
19 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

cough during extubation

Time Frame: 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 Outcomes

  • Changes of blood pressure(Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.)
  • Changes of heart rate(Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.)
  • Number of Participants with airway complications after extubation(From extubation to 5 minutes after extubation)
  • Adequate tidal volume during mechanical ventilation(From insertion of airway device to extubation)
  • Adequate ventilation during mechanical ventilation(From insertion of airway device to extubation)
  • Airway pressure during mechanical ventilation(From insertion of airway device to extubation)
  • Number of Participants with blood contamination at vocal cord and distal trachea(Between the end of surgery and extubation)
  • Number of Participants with postoperative airway complications(30 minutes after surgery and postoperative 1 day)
  • Changes of saturation(Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.)
  • Device blood contamination(At airway device removal)
  • Time to eye opening and time to extubation(From anesthetic discontinuation to eye opening and extubation)

Investigators

Sponsor
Ajou University School of Medicine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jong Yeop Kim

Principal investigator

Ajou University School of Medicine

Study Sites (2)

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