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

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 Overview

• Status: Not yet recruiting
• Conditions: Postoperative Complications; Intubation Times; The Device Placement Times
• Intervention / Treatment: Other: Video Laryngeal Mask; Other: Fastrack Laryngeal Mask

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• Turkey
  • Ankara
    • Çankaya, Ankara, Turkey
      • Yusuf
      • Contact: Yusuf Ozguner; Phone Number: 05427150725; Email: y.ozguner@hotmail.com
  • Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle
    • Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, Turkey, 06170
      • Ankara Etlik City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Surgical patients undergoing elective surgery and intubated under general anesthesia.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Video Laryngeal Mask; Patients who are intubated using Video Laryngeal Mask for intubation purposes will be included.	Other: Video Laryngeal Mask; 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.	Other: Fastrack Laryngeal Mask; Patients who are intubated using Fastrack Laryngeal Mask for intubation purposes will be included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laryngeal Mask Placement times(minute)	Laryngeal Mask Placement times(minute)	3 minutes after induction of anesthesia
Intubation times	Intubation times	3 minutes after induction of anesthesia
Number of failed attempts	Number of failed attempts	3 minutes after induction of anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sore throat	Postoperative complications	0-2-4-8-12-24 hours postoperatively
Hoarseness	Postoperative complications	0-2-4-8-12-24 hours postoperatively
Nausea-vomiting	Postoperative complications	0-2-4-8-12-24 hours postoperatively
Need for additional antiemetic medication	Postoperative complications	0-2-4-8-12-24 hours postoperatively

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): November 10, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: October 29, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Fastrack Laryngeal Mask; Video Laryngeal Mask
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: AnkaraEtlikYusufOzguner006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No