NCT06121895

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 10, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

December 4, 2024

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

October 29, 2023

Last Update Submit

November 30, 2024

Conditions

The Device Placement TimesIntubation TimesPostoperative Complications

Keywords

Fastrack Laryngeal MaskVideo Laryngeal Mask

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Sore throat

    0-2-4-8-12-24 hours postoperatively

  • Hoarseness

    0-2-4-8-12-24 hours postoperatively

  • Nausea-vomiting

    0-2-4-8-12-24 hours postoperatively

  • Need for additional antiemetic medication

    0-2-4-8-12-24 hours postoperatively

Study Arms (2)

Video Laryngeal Mask

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

Other: Video Laryngeal Mask

Fastrack Laryngeal Mask

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

Other: Fastrack Laryngeal Mask

Interventions

Video Laryngeal MaskOTHER

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

Video Laryngeal Mask
Fastrack Laryngeal MaskOTHER

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

Fastrack Laryngeal Mask

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgical patients undergoing elective surgery and intubated under general anesthesia.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, 06170, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 26556848RESULT

  • 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.

    PMID: 34919170RESULT

  • 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.

    PMID: 11684987RESULT

  • 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.

    PMID: 40596865DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yusuf Ozguner

    Ankara Etlik City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 29, 2023

First Posted

November 8, 2023

Study Start

December 10, 2023

Primary Completion

April 1, 2024

Study Completion

August 15, 2024

Last Updated

December 4, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)