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CompletedNCT04520555Updated Jul 20, 2022

Flexible Laryngeal Mask Airway Versus Tracheal Intubation in Nasal Bone Fracture

An interventional study of Laryngeal mask airway and Endotracheal tube in Laryngeal Mask Airway, sponsored by Ajou University School of Medicine. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-07-20.

Sponsored by Ajou University School of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
19 Years to 70 Years
Sex
All
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Study 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.

02

Conditions studied

  • Laryngeal Mask Airway

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Keywords

  • Laryngeal mask airway
  • Intubation
  • nasal bone fracture
  • recovery
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 70 is close to the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Ajou University School of Medicine is the lead sponsor of 171 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 70 Years
Sexes eligible
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

Exclusion Criteria:

  • Patients with high risk of aspiration, patients who anticipated difficult airway
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Laryngeal mask airway group

    Flexible laryngeal mask airway is inserted for general anesthesia

    Device: Laryngeal mask airway

  • Active comparator
    intubation group

    Endotracheal intubation was performed for general anesthesia

    Device: Endotracheal tube

Interventions

  • DeviceLaryngeal 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

    Also known as: LMA Flexible,Teleflex Co., Westmeath, Ireland

  • DeviceEndotracheal tube

    Endotracheal tube is a plain tube, which is most commonly used in general anesthesia.

    Also known as: Portex, Smiths Medical International Ltd., South East England, United Kingdom

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What researchers measure

Primary outcomes

  1. 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)

    Time frame: From end of surgery to extubation

Secondary outcomes

  1. Adequate tidal volume during mechanical ventilation

    Tidal volume (ml)

    Time frame: From insertion of airway device to extubation

  2. Adequate ventilation during mechanical ventilation

    end-tidal carbon dioxide

    Time frame: From insertion of airway device to extubation

  3. Airway pressure during mechanical ventilation

    peak and mean airway pressure

    Time frame: From insertion of airway device to extubation

  4. Changes of heart rate

    Heart rate

    Time frame: Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.

  5. Changes of blood pressure

    mean blood pressure

    Time frame: Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.

  6. Changes of saturation

    peripheral saturation

    Time frame: Before anethetic induction, 1 minute after intubation, the end of surgery, 1 minute after extubation.

  7. Number of Participants with blood contamination at vocal cord and distal trachea

    Blood contamination was examined using fibrobronchoscope.

    Time frame: Between the end of surgery and extubation

  8. 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

    Time frame: At airway device removal

  9. Number of Participants with airway complications after extubation

    laryngospasm, hypoventilation (respiratory rate \<8/minutes), desaturation (peripheral pulse oximetry saturation \<95%)

    Time frame: From extubation to 5 minutes after extubation

  10. 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

    Time frame: From anesthetic discontinuation to eye opening and extubation

  11. Number of Participants with postoperative airway complications

    Sore throat, hoarseness, dysphagia, and nausea and vomiting

    Time frame: 30 minutes after surgery and postoperative 1 day

07

Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04520555
Lead sponsor
Ajou University School of Medicine
Responsible party
Jong Yeop Kim (Principal investigator, Ajou University School of Medicine) — Principal investigator
First posted
Aug 20, 2020
Start date
Jul 13, 2020
Primary completion
Jan 26, 2022
Completion
Jan 27, 2022
Last update
Jul 20, 2022

Study contacts

JongYeop Kim, M.D.,Ph.D.
principal investigator · Ajou University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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