Fiberoptic Bronchoscopy on Supraglottic Airway Devices Position

NCT06775184 | Not Yet Recruiting FDA Device

• 1 other identifier: KMUHIRB-F(I)-20240331
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

A comparison of SaCo VLMTM video laryngeal mask airway with the I-gel supraglottic airway during airway management in patients undergoing elective surgery.

Conditions

Supraglottic Airway Devices Position

Keywords

supraglottic device; video laryngeal mask; fiberoptic bronchoscopy

Outcome Measures

Primary Outcomes (1)

• glottic visualization grades by fiberoptic exam assessment

  Grade 1: vocal cords were not visualizedGrade 2: vocal cords and anterior epiglottis were visualizedGrade 3: vocal cords and posterior epiglottis were visualized Grade 4: vocal cords only were visualized

  From anesthesia induction to the end of surgery

Secondary Outcomes (1)

• Intra-operative effectiveness

  From anesthesia induction to the end of surgery

Study Arms (2)

Third-generation SADs (SaCoVLM)

EXPERIMENTAL

The third-generation SADs (i.e. SaCoVLM™) combines video system and laryngeal mask with gastric drain.

Device: a native video image system

Second-generation SADs (I-gel™)

ACTIVE COMPARATOR

The second-generation SADs (i.e. I-gel™) with a gastric drain conduit have designed to reduce the risk of gastric reflux and aspiration.

Device: a native video image system; Device: Fiberoptic bronchoscope

Interventions

a native video image system DEVICE

The visualization of the glottic structures through the SaCoVLM™ imaging system is graded as follows: Grade1: Visibility of the lateral portion of the right epiglottic fold and part of the laryngeal inlet. Grade 2: Visibility of both epiglottic folds and part of the laryngeal inlet. Grade 3: Visibility of the laryngeal inlet and part of the vocal cords. Grade 4: Visibility of the entire vocal cords.

Second-generation SADs (I-gel™); Third-generation SADs (SaCoVLM)

Fiberoptic bronchoscope DEVICE

The position of the i-Gel is checked using a fiberoptic endoscope

Second-generation SADs (I-gel™)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Central Study Contacts

ICHENG LU

CONTACT

886-975356677; u9251112@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 15, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 15, 2025

Record last verified: 2025-01