Fiberoptic Bronchoscopy on Supraglottic Airway Devices Position

Kaohsiung Medical University

Status: Not yet enrolling

Conditions: Supraglottic Airway Devices Position

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06775184

KMUHIRB-F(I)-20240331

Details and patient eligibility

About

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

Full description

The position of the supraglottic airway is checked using a fiberoptic endoscope: The bronchoscope is placed at the opening of the laryngeal mask, and assessed using the following grading system: Grade 1: Vocal cords not visible. Grade 2: Vocal cords and anterior epiglottis visible. Grade 3: Vocal cords and posterior epiglottis visible. Grade 4: Only vocal cords visible.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Third-generation SADs (SaCoVLM)

Experimental group

Description:

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

Treatment:

Device: a native video image system

Second-generation SADs (I-gel™)

Active Comparator group

Description:

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

Treatment:

Device: a native video image system

Device: Fiberoptic bronchoscope