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Clinical Trials/NCT06121895
NCT06121895CompletedNot Applicable

Evaluation of Differences in Placement Success and Postoperative Complications Between Video Laryngeal Mask Airway and Fastrack Laryngeal Mask

Ankara Etlik City Hospital1 site in 1 country101 target enrollmentStarted: December 10, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
101
Locations
1
Primary Endpoint
Intubation times

Study Overview

Brief Summary

In our study, patients who are intubated using VLM and Fastrack LMA for intubation purposes will be included. The placement times, intubation times, and the number of failed attempts for both devices will be recorded. Additionally, postoperative complications (sore throat, hoarseness, nausea-vomiting, additional antiemetic medication requirements, etc.) will be monitored and recorded.

Detailed Description

The 2015 Difficult Airway Society guidelines specify that in cases where an unexpectedly difficult airway is encountered, and the initial intubation attempt is unsuccessful, the insertion of a supraglottic airway device (SAD) is recommended to maintain ventilation and oxygenation, followed by tracheal intubation through the SAD. SAD has been designated as a rescue airway device in difficult airway algorithms and resuscitation guidelines to "buy time." Additionally, SAD is used to maintain airway and anesthesia in surgeries that do not require intubation.

The Video Laryngeal Mask (VLM) is a newly developed type of SAD. With VLM, direct visualization of the glottis is achieved immediately after SAD placement. VLM has a channel that allows for endotracheal tube passage for intubation purposes and provides direct visualization. The Fastrack LMA, on the other hand, possesses all the ventilation features of classic SADs but is designed for blind or fiberoptic-guided tracheal intubations. These devices are used as rescue devices in cases of limited neck extension and difficult airway situations. Both devices are routinely used for ventilation and intubation purposes in patients. The use of these two devices is preferred in patients where neck extension is undesirable or neck movements are restricted for intubation purposes.

In our study, patients who are intubated using VLM and Fastrack LMA for intubation purposes will be included. The placement times, intubation times, and the number of failed attempts for both devices will be recorded. Additionally, postoperative complications (sore throat, hoarseness, nausea-vomiting, additional antiemetic medication requirements, etc.) will be monitored and recorded.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Individuals between the ages of 18 and
  • •Patients with ASA (American Society of Anesthesiologists) scores I, II, or III.
  • •Patients undergoing surgery under general anesthesia in the operating room.

Exclusion Criteria

  • •Patients under 18 years old or over 80 years old.
  • •Patients who refuse to participate in the study.

Outcomes

Primary Outcomes

Intubation times

Time Frame: 3 minutes after induction of anesthesia

Intubation times

Number of failed attempts

Time Frame: 3 minutes after induction of anesthesia

Number of failed attempts

Laryngeal Mask Placement times(minute)

Time Frame: 3 minutes after induction of anesthesia

Laryngeal Mask Placement times(minute)

Secondary Outcomes

  • Sore throat(0-2-4-8-12-24 hours postoperatively)
  • Need for additional antiemetic medication(0-2-4-8-12-24 hours postoperatively)
  • Hoarseness(0-2-4-8-12-24 hours postoperatively)
  • Nausea-vomiting(0-2-4-8-12-24 hours postoperatively)

Investigators

Sponsor
Ankara Etlik City Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Yusuf Özgüner

Principal Investigator

Ankara Etlik City Hospital

Study Sites (1)

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