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Clinical Trials/NCT07365449
NCT07365449CompletedNot Applicable

Visual Versus Conventional Intubation: Comparison of SaCoVLM™ Video Laryngeal Mask and Direct Laryngoscopy : A Prospective Observational Study

Akdeniz University1 site in 1 country204 target enrollmentStarted: March 29, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
204
Locations
1
Primary Endpoint
Change in Mean Arterial Pressure During Intubation

Study Overview

Brief Summary

This is a prospective, observational study designed to evaluate airway management techniques used during elective surgery under general anesthesia. The study focuses on perioperative hemodynamic parameters and airway-related procedural characteristics.

Detailed Description

Study Design This is a single-center, prospective, observational study conducted at Akdeniz University Hospital after approval by the Institutional Ethics Committee (Approval No: 70904504/139). Written informed consent was obtained from all participants prior to enrollment.

Participants Adult patients scheduled for elective surgery under general anesthesia between March and June 2024 were screened for inclusion.

Exclusion Criteria Patients were excluded if they were under 18 years of age, pregnant, had known hypersensitivity to anesthetic agents, gastroesophageal reflux disease, or active upper respiratory tract infection.

Group Allocation and Airway Management

Due to the observational design of the study, randomization was not performed. Patients were allocated to groups according to the airway management technique selected by the attending anesthesiologist:

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥ 18 years
  • Scheduled for elective surgery under general anesthesia
  • Requires tracheal intubation as part of the planned anesthetic technique
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Able to provide written informed consent

Exclusion Criteria

  • Age < 18 years
  • Known or suspected hypersensitivity to anesthetic agents used in the protocol
  • History of gastroesophageal reflux disease or increased risk of aspiration
  • Active upper respiratory tract infection
  • Predicted difficult airway (Mallampati class IV, mouth opening < 3 cm, limited neck mobility)
  • Severe cardiopulmonary instability
  • Emergency surgery
  • Upper airway pathology (airway trauma, tumor, edema, infection)
  • Coagulopathy or bleeding tendency
  • Inability to cooperate or provide informed consent

Arms & Interventions

Group 1: SaCoVLM™ Video Laryngeal Mask Group 2: Direct Laryngoscopy

Group 1: SaCoVLM™ Video Laryngeal Mask (VLM), "Intubation performed using SaCoVLM™ video laryngeal mask under general anesthesia."

Group 2: Direct Laryngoscopy (DL),: "Intubation performed using direct laryngoscopy under general anesthesia."

Outcomes

Primary Outcomes

Change in Mean Arterial Pressure During Intubation

Time Frame: Baseline (pre-induction) and 1 minute after endotracheal tube placement

Mean arterial pressure (MAP) measured non-invasively at baseline (before induction of anesthesia) and at 1 minute after successful endotracheal tube placement.

Secondary Outcomes

  • First-Attempt Intubation Success(During airway instrumentation (peri-procedural) Unit of Measure Percentage (%))
  • Heart Rate Response to Intubation(Baseline (pre-induction) and 1 minute after endotracheal tube placement Unit of Measure beats per minute)
  • Oxygen Saturation During Airway Management(Baseline and during airway instrumentation Unit of Measure Percentage (%))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Emel Gunduz

Associate Professor of Anesthesiology, Akdeniz University, Antalya, Turkey

Akdeniz University

Study Sites (1)

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