Comparative of Video Laryngeal Mask and Endotracheal Intubation in Patients Undergoing Tympanoplasty Surgery.

NCT07084636 | Completed

• 1 other identifier: GOKAEK 2024/21/10
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The effects of video laryngeal mask and endotracheal intubation on hemodynamic parameters and the development of postoperative respiratory complications in participants scheduled for tympanoplasty will be evaluated.

Conditions

Tympanoplasty Surgery; Laryngeal Mask Airway

Keywords

tympanoplasty; video laryngeal mask; airway; intubation; general anesthesia

Outcome Measures

Primary Outcomes (1)

• Time to Effective Airway

  The time to achieve an effective airway was defined as the time between removing the face mask, attaching the airway device, and obtaining 3 square wave capnograph traces with manual ventilation.

  Baseline

Secondary Outcomes (4)

• Number of attempts taken for successful placement of airway device

  Baseline

• Haemodynamic response to insertion of airway device

  Baseline, 1st minute, 5th minute

• Displacement of the SaCoVLM™ video laryngeal mask in head position

  Baseline

• Incidence of post-operative sore throat

  24 hours after surgery

Study Arms (2)

Group Laryngeal Mask Airway

ACTIVE COMPARATOR

In this group, after 3 minutes of preoxygenation, 2 mg/kg propofol will be administered intravenously. A laryngeal mask will be placed after induction, the cuf will be inflated and fixed with a cuf manometer.

Other: Video Laryngeal Mask

Group Endotracheal Tube

ACTIVE COMPARATOR

In this group, after 3 minutes of preoxygenation, 2 mg/kg propofol will be administered intravenously, 1 mcg/kg fentanyl will be administered intravenously. Additionally, 0.6 mg/kg rocuronium will be administered intravenously and endotracheal intubation will be performed, and the cuff will be inflated and fixed with a cuff manometer.

Other: Endotracheal intubation

Interventions

Video Laryngeal Mask OTHER

Video laryngeal mask will be used in this group

Group Laryngeal Mask Airway

Endotracheal intubation OTHER

Endotracheal intubation will be performed in this group.

Group Endotracheal Tube

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged 18-75
• Participants with ASA I-II-III
• Cases with surgery duration of less than two hours

You may not qualify if:

• Participants under 18 years of age
• Participants who are pregnant
• Participants with a difficult airway diagnosis
• Participants with a mouth opening of less than 4 cm

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Samsun University, Samsun Training and Research Hospital

Samsun, Ilkadım, 55000, Turkey (Türkiye)

Location

Related Publications (3)

• Sun Y, Huang L, Xu L, Zhang M, Guo Y, Wang Y. The Application of a SaCoVLMTM Visual Intubation Laryngeal Mask for the Management of Difficult Airways in Morbidly Obese Patients: Case Report. Front Med (Lausanne). 2021 Nov 18;8:763103. doi: 10.3389/fmed.2021.763103. eCollection 2021.

  PMID: 34869469 BACKGROUND

• Yan CL, Chen Y, Sun P, Qv ZY, Zuo MZ. Preliminary evaluation of SaCoVLM video laryngeal mask airway in airway management for general anesthesia. BMC Anesthesiol. 2022 Jan 3;22(1):3. doi: 10.1186/s12871-021-01541-0.

  PMID: 34979936 BACKGROUND

• Choi WJ, Kim YH. The influence of head rotation on ProSeal laryngeal mask airway sealing during paediatric myringotomy. Anaesth Intensive Care. 2007 Dec;35(6):957-60. doi: 10.1177/0310057X0703500617.

  PMID: 18084990 BACKGROUND

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• HATİCE SELÇUK KUŞDERCİ, asst prof

  SAMSUN UNİVERSITY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 24, 2025
• Study Start: December 1, 2024
• Primary Completion: July 5, 2025
• Study Completion: July 17, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)