Flexible Laryngeal Mask Airway Versus Tracheal Intubation in Nasal Bone Fracture

NCT04520555 | Completed

• 1 other identifier: AJIRB-MED-OBS-20-081
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngeal Mask Airway

Keywords

Laryngeal mask airway; Intubation; nasal bone fracture; recovery

Outcome Measures

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)

  From end of surgery to extubation

Secondary Outcomes (11)

• 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

• Changes of heart rate

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

• Changes of blood pressure

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

Study Arms (2)

Laryngeal mask airway group

EXPERIMENTAL

Flexible laryngeal mask airway is inserted for general anesthesia

Device: Laryngeal mask airway

intubation group

ACTIVE COMPARATOR

Endotracheal intubation was performed for general anesthesia

Device: Endotracheal tube

Interventions

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

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

Laryngeal mask airway group

Endotracheal tube DEVICE

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

intubation group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with American Society of Anesthesiologists classification 1 or 2 who receive general anesthesia due to nasal bone fracture

You may not qualify if:

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

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University Hospital

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

Location

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• JongYeop Kim, M.D.,Ph.D.

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 20, 2020
• Study Start: July 13, 2020
• Primary Completion: January 26, 2022
• Study Completion: January 27, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

KR (1)