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Completed

NCT Number: NCT06121895

Evaluation of Differences in Video Laryngeal Mask Airway and Fastrack Laryngeal Mask

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Etlik City Hospital

Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, 06170, Turkey (Türkiye)

About this study

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.

Who can participate

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

Inclusion criteria

  • Individuals between the ages of 18 and 80.
  • 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.

Treatment and study plan

Video Laryngeal Mask

Other

Patients who are intubated using Video Laryngeal Mask for intubation purposes will be included.

Fastrack Laryngeal Mask

Other

Patients who are intubated using Fastrack Laryngeal Mask for intubation purposes will be included.

Primary outcomes

  1. Laryngeal Mask Placement times(minute)

    Time frame: 3 minutes after induction of anesthesia

    Laryngeal Mask Placement times(minute)

  2. Intubation times

    Time frame: 3 minutes after induction of anesthesia

    Intubation times

  3. Number of failed attempts

    Time frame: 3 minutes after induction of anesthesia

    Number of failed attempts

Secondary outcomes

  1. Sore throat

    Time frame: 0-2-4-8-12-24 hours postoperatively

    Postoperative complications

  2. Hoarseness

    Time frame: 0-2-4-8-12-24 hours postoperatively

    Postoperative complications

  3. Nausea-vomiting

    Time frame: 0-2-4-8-12-24 hours postoperatively

    Postoperative complications

  4. Need for additional antiemetic medication

    Time frame: 0-2-4-8-12-24 hours postoperatively

    Postoperative complications

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2023
Registry last updated
Dec 4, 2024

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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