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Completed

NCT Number: NCT04520555

Flexible Laryngeal Mask Airway Versus 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.

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Key information

Conditions

Laryngeal Mask Airway

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou University Hospital

Suwon, Gyeongki-do, 443-721, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laryngeal mask airway

Device

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

Endotracheal tube

Device

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

Primary outcomes

  1. 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

  1. Adequate tidal volume during mechanical ventilation

    Time frame: From insertion of airway device to extubation

    Tidal volume (ml)

  2. Adequate ventilation during mechanical ventilation

    Time frame: From insertion of airway device to extubation

    end-tidal carbon dioxide

  3. Airway pressure during mechanical ventilation

    Time frame: From insertion of airway device to extubation

    peak and mean airway pressure

  4. Changes of heart rate

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

    Heart rate

  5. Changes of blood pressure

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

    mean blood pressure

  6. Changes of saturation

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

    peripheral saturation

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

    Time frame: Between the end of surgery and extubation

    Blood contamination was examined using fibrobronchoscope.

  8. Device blood contamination

    Time frame: At airway device removal

    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

  9. Number of Participants with airway complications after extubation

    Time frame: From extubation to 5 minutes after extubation

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

  10. Time to eye opening and time to extubation

    Time frame: From anesthetic discontinuation to eye opening and extubation

    Time in seconds from anesthetic discontinuation to eye opening at verbal commend and time in seconds from anesthetic discontinuation to extubation

  11. Number of Participants with postoperative airway complications

    Time frame: 30 minutes after surgery and postoperative 1 day

    Sore throat, hoarseness, dysphagia, and nausea and vomiting

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 20, 2020
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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