Visual Versus Conventional Intubation Using the SaCoVLM Video Laryngeal Mask

NCT07365449 | Completed

• 1 other identifier: AKDENIZ_SACOVLM_INTUBATION_01
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Management

Keywords

Airway management;; Video laryngoscopy;; Hemodynamics;; Intubation

Outcome Measures

Primary Outcomes (1)

• Change in Mean Arterial Pressure During Intubation

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

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

Secondary Outcomes (3)

• 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 (%)

Study Arms (1)

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."

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study included adult patients (≥18 years old) scheduled for elective surgery under general anesthesia at Akdeniz University Hospital between March and June 2024. Both male and female patients were eligible. Patients with known hypersensitivity to anesthetic agents, pregnant patients, those with gastroesophageal reflux disease, or active upper respiratory tract infections were excluded. A total of 204 patients were enrolled.

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 years
• Pregnancy
• 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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Hospital

Antalya, Please Select:, 07050, Turkey (Türkiye)

Location

Related Publications (2)

• 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 RESULT

• Yan CL, Zhang YQ, Chen Y, Qv ZY, Zuo MZ. To compare the influence of blind insertion and up-down optimized glottic exposure manoeuvre on oropharyngeal leak pressure using SaCoVLM video laryngeal mask among patients undergoing general anesthesia. J Clin Monit Comput. 2023 Apr;37(2):593-598. doi: 10.1007/s10877-022-00930-1. Epub 2022 Oct 29.

  PMID: 36308611 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology, Akdeniz University, Antalya, Turkey

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: January 26, 2026
• Study Start: March 29, 2025
• Primary Completion: November 10, 2025
• Study Completion: December 23, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)