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

NCT ID: NCT06121895

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-10

Study Completion Date

2024-08-15

Brief Summary

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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

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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.

Conditions

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The Device Placement Times Intubation Times Postoperative Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Video Laryngeal Mask

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

Video Laryngeal Mask

Intervention Type OTHER

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

Fastrack Laryngeal Mask

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

Fastrack Laryngeal Mask

Intervention Type OTHER

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

Interventions

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Video Laryngeal Mask

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

Intervention Type OTHER

Fastrack Laryngeal Mask

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Yusuf Özgüner

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yusuf Ozguner

Role: PRINCIPAL_INVESTIGATOR

Ankara Etlik City Hospital

Locations

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Ankara Etlik City Hospital

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

Site Status

Countries

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Turkey (Türkiye)

References

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Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10.

Reference Type RESULT
PMID: 26556848 (View on PubMed)

Van Zundert AAJ, Gatt SP, Van Zundert TCRV, Kumar CM, Pandit JJ. Features of new vision-incorporated third-generation video laryngeal mask airways. J Clin Monit Comput. 2022 Aug;36(4):921-928. doi: 10.1007/s10877-021-00780-3. Epub 2021 Dec 17.

Reference Type RESULT
PMID: 34919170 (View on PubMed)

Ferson DZ, Rosenblatt WH, Johansen MJ, Osborn I, Ovassapian A. Use of the intubating LMA-Fastrach in 254 patients with difficult-to-manage airways. Anesthesiology. 2001 Nov;95(5):1175-81. doi: 10.1097/00000542-200111000-00022.

Reference Type RESULT
PMID: 11684987 (View on PubMed)

Ozguner Y, Ozagar UC, Kina SF, Sezgi A, Altinsoy S, Ergil J. Comparison of sacovlm video laryngeal mask-guided intubation and fastrach combined with flexible bronchoscopy-guided intubation -a prospective study. BMC Anesthesiol. 2025 Jul 1;25(1):315. doi: 10.1186/s12871-025-03172-1.

Reference Type DERIVED
PMID: 40596865 (View on PubMed)

Other Identifiers

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AnkaraEtlikYusufOzguner006

Identifier Type: -

Identifier Source: org_study_id