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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06121895
Enrollment
101
Registered
2023-11-08
Start date
2023-12-10
Completion date
2024-08-15
Last updated
2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation Times, Postoperative Complications, The Device Placement Times

Keywords

Fastrack Laryngeal Mask, Video Laryngeal Mask

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.

Interventions

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

OTHERFastrack Laryngeal Mask

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

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

Inclusion criteria

1. Individuals between the ages of 18 and 80. 2. Patients with ASA (American Society of Anesthesiologists) scores I, II, or III. 3. Patients undergoing surgery under general anesthesia in the operating room.

Exclusion criteria

1. Patients under 18 years old or over 80 years old. 2. Patients who refuse to participate in the study.

Design outcomes

Primary

MeasureTime frameDescription
Number of failed attempts3 minutes after induction of anesthesiaNumber of failed attempts
Laryngeal Mask Placement times(minute)3 minutes after induction of anesthesiaLaryngeal Mask Placement times(minute)
Intubation times3 minutes after induction of anesthesiaIntubation times

Secondary

MeasureTime frameDescription
Sore throat0-2-4-8-12-24 hours postoperativelyPostoperative complications
Need for additional antiemetic medication0-2-4-8-12-24 hours postoperativelyPostoperative complications
Hoarseness0-2-4-8-12-24 hours postoperativelyPostoperative complications
Nausea-vomiting0-2-4-8-12-24 hours postoperativelyPostoperative complications

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026