Fiberoptic Bronchoscopy on Supraglottic Airway Devices Position

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

About this trial

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

Eligibility criteria

This trial does not accept 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

Parallel

Treatments tested in this trial

  • 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.

  • Fiberoptic bronchoscope

    Device

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Third-generation SADs (SaCoVLM)Experimental treatment 1 intervention
Group B: Second-generation SADs (I-gel™)Active comparator 2 interventions

Trial outcomes

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

Time frame
From anesthesia induction to the end of surgery

Secondary outcomes

1

Intra-operative effectiveness

Secondary outcomes were evaluated by oropharyngeal sealing pressure, first attempt success rate, insertion time

Time frame
From anesthesia induction to the end of surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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