Skip to main content
OpenTrials
Completed

NCT Number: NCT07084636

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tympanoplasty Surgery Laryngeal Mask Airway

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsun University, Samsun Training and Research Hospital

Samsun, Ilkadım, 55000, Turkey (Türkiye)

About this study

Procedures to be performed under general anesthesia are performed by placing endotracheal intubation and laryngeal mask in the airway. Video Laryngeal Mask (LMA) combines the upper glottic airway device with video laryngoscope tracheal intubation. LMA placement and tracheal intubation can be visualized, LMA position can be continuously monitored during the operation, and adverse events such as LMA displacement can be managed in a timely manner. Studies have shown that video LMA has extraordinary advantages in airway management. This study aimed to compare video LMA and endotracheal intubation in participants who will undergo tympanoplasty surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Video Laryngeal Mask

Other

Video laryngeal mask will be used in this group

Endotracheal Intubation

Other

Endotracheal intubation will be performed in this group.

Primary outcomes

  1. Time to Effective Airway

    Time frame: Baseline

    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.

Secondary outcomes

  1. Number of attempts taken for successful placement of airway device

    Time frame: Baseline

    Number of attempts needed for successful placement of either the SaCoVLM™ video laryngeal mask airway the tracheal tube, as assigned

  2. Haemodynamic response to insertion of airway device

    Time frame: Baseline, 1st minute, 5th minute

    Systolic blood pressure and heart rate at 0th minute, 1st minute 5th minute, starting from the time the face mask was removed from the patient's face.

  3. Displacement of the SaCoVLM™ video laryngeal mask in head position

    Time frame: Baseline

    Effect of Head Rotation During Tympanoplasty on laryngeal visibility with the SaCoVLM™ Laryngeal Mask during head rotation

  4. Incidence of post-operative sore throat

    Time frame: 24 hours after surgery

    postoperative sore throat will be recorded at 1st hour, 6th hour, 12th hour, 18th hour, 24th hour

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.