Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07084636
Enrollment
98
Registered
2025-07-24
Start date
2024-12-01
Completion date
2025-07-17
Last updated
2025-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngeal Mask Airway, Tympanoplasty Surgery

Keywords

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

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.

Detailed description

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.

Interventions

Video laryngeal mask will be used in this group

OTHEREndotracheal intubation

Endotracheal intubation will be performed in this group.

Sponsors

Samsun University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to Effective AirwayBaselineThe 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

MeasureTime frameDescription
Number of attempts taken for successful placement of airway deviceBaselineNumber of attempts needed for successful placement of either the SaCoVLM™ video laryngeal mask airway the tracheal tube, as assigned
Haemodynamic response to insertion of airway deviceBaseline, 1st minute, 5th minuteSystolic 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.
Displacement of the SaCoVLM™ video laryngeal mask in head positionBaselineEffect of Head Rotation During Tympanoplasty on laryngeal visibility with the SaCoVLM™ Laryngeal Mask during head rotation
Incidence of post-operative sore throat24 hours after surgerypostoperative sore throat will be recorded at 1st hour, 6th hour, 12th hour, 18th hour, 24th hour

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026