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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06121895
• Other study ID #: AnkaraEtlikYusufOzguner006
• Status: Not yet recruiting
• Start date: November 10, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: November 2023
• Source: Ankara Etlik City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 1, 2024
• Est. primary completion date: February 1, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intubation Times
• Postoperative Complications

Intervention

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.

Locations

Country	Name	City	State
Turkey	Ankara Etlik City Hospital	Ankara	Varlik Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle
Turkey	Yusuf	Çankaya	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Etlik City Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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 intubat — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laryngeal Mask Placement times(minute)	Laryngeal Mask Placement times(minute)	3 minutes after induction of anesthesia
Primary	Intubation times	Intubation times	3 minutes after induction of anesthesia
Primary	Number of failed attempts	Number of failed attempts	3 minutes after induction of anesthesia
Secondary	Sore throat	Postoperative complications	0-2-4-8-12-24 hours postoperatively
Secondary	Hoarseness	Postoperative complications	0-2-4-8-12-24 hours postoperatively
Secondary	Nausea-vomiting	Postoperative complications	0-2-4-8-12-24 hours postoperatively
Secondary	Need for additional antiemetic medication	Postoperative complications	0-2-4-8-12-24 hours postoperatively