Clinical trial NCT06121895: Evaluation of Differences in Video Laryngeal Mask Airway and Fastrack Laryngeal Mask
Official title: Evaluation of Differences in Placement Success and Postoperative Complications Between Video Laryngeal Mask Airway and Fastrack Laryngeal Mask
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Device Placement Times
Intubation Times
Postoperative Complications
Keywords: Fastrack Laryngeal Mask
Video Laryngeal Mask
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-11-08
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical patients undergoing elective surgery and intubated under general anesthesia.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Laryngeal Mask Placement times(minute)
timeFrame: 3 minutes after induction of anesthesia
measure: Intubation times
timeFrame: 3 minutes after induction of anesthesia
measure: Number of failed attempts
timeFrame: 3 minutes after induction of anesthesia
Secondary outcomes:
measure: Sore throat
timeFrame: 0-2-4-8-12-24 hours postoperatively
measure: Hoarseness
timeFrame: 0-2-4-8-12-24 hours postoperatively
measure: Nausea-vomiting
timeFrame: 0-2-4-8-12-24 hours postoperatively
measure: Need for additional antiemetic medication
timeFrame: 0-2-4-8-12-24 hours postoperatively
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
state: Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle
Study officials:
affiliation: Ankara Etlik City Hospital
name: Yusuf Ozguner
role: PRINCIPAL_INVESTIGATOR
References:
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 intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10.
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.
citation: 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.