Optimizing Third-Generation Video Laryngeal Mask Position: SaCoVLM™ vs. Fiberoptic Bronchoscope

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKaohsiung Medical University Chung-Ho Memorial Hospital

About this trial

This study aims to compare the effectiveness of SaCoVLM™ in artificial airway ventilation during general anesthesia, focusing on the correlation between native video camera imaging and fiberoptic endoscopy. Primary outcomes include the analysis of imaging correlation, while secondary outcomes assess initial placement success rates, difficulty, blood clot adherence, vital sign changes, and postoperative complications.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

ASA classification I~III, age 18~65 y/o, BMI 18~30kg/m2, elective surgery, surgery duration < 2 hours, supine position, general anesthesia with laryngeal mask airway insertion

Disqualifiers

Smoking, betel nuts use, any known anatomical variation or disease of facial or airway structure, anticipated difficult airway, limited mouth opening distance or neck motility, loosening teeth, gastroesophageal reflux history, ongoing upper airway infection or inflammation symptoms

Trial design

Design model

Single group

Treatments tested in this trial

  • video image through laryngeal mask specific channel

    Diagnostic test

    patients placed SaCoVLM will be checked the proper position of placement by native camera through specific video channel and fiberoptic endoscopy through ventilation channel perspectively

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: patients placed SaCoVLM checked position by real-time video imageExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

correlation of native camera image of SaCoVLM and traditional fiberoptic endoscopy image

The primary outcome is the analysis of the correlation between the two types of imaging, native camera image of SaCoVLM and traditional fiberoptic endoscopy image, to confirm proper position of laryngeal mask placement.

Time frame
From enrollment to postoperative day 1

Secondary outcomes

1

the success rate and difficulty of initial placement of the SaCoVLM™

One of the secondary outcomes is the success rate and difficulty of initial placement of the SaCoVLM™. We will record the number of attempts to place or adjust the laryngeal mask to proper position.

Time frame
From enrollment to postoperative day 1
2

whether visible blood clots adhere to the device upon removal

One of the secondary outcomes is whether visible blood clots adhere to the device upon removal.

Time frame
From enrollment to postoperative day 1
3

changes in heart rate values before and after SaCoVLM placement

One of the secondary outcomes is changes in heart rate values before and after SaCoVLM placement.

Time frame
From enrollment to postoperative day 1
4

changes in mean arterial blood pressure values before and after SaCoVLM placement

One of the secondary outcomes is changes in mean arterial blood pressure values before and after SaCoVLM placement.

Time frame
From enrollment to postoperative day 1

Other outcomes

Sponsors and contacts

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