NCT04724408

VieScope Versus Direct Laryngoscopic Intubation

Endotracheal Intubation With VieScope Versus Direct Laryngoscopic Intubation in Patients for Elective Surgery - a Prospective Randomized Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients requiring endotracheal intubation for elective surgery without expected difficult airway are randomized to be intubated either by a) VieScope or b) conventional direct laryngoscopy.

Detailed description

Endotracheal intubation is required for different surgical procedures for mechanical ventilation and to prevent aspiration of secretions. Endotracheal intubation is usually performed by direct laryngoscopy (DL), i.e. during otorhinolaryngologic or oral and maxillofacial surgery. This technique has limitations and may fail due to insufficient visualization of the larynx. A new device has been introduced that consists of an illuminated straight plastic tube for laryngoscopy (VSC, Vie Scope, Adroit Surgical, Oklahoma City, OK, USA) that enables for indirect intubation over a stylet. So far, the VSC has shown promising results in manikin studies for intubation in normal and difficult airways and was shown to be superior over conventional laryngoscopy during cardiopulmonary resuscitation with providers wearing personal protective equipment. Data in elective patients undergoing otorhinolaryngologic or oral and maxillofacial surgery are not available, so far. Therefore, we aim to test the VSC in patients compared to conventional techniques in a prospective randomized non-inferiority trial. We aim to test the VSC in predicted non-difficult airway patients. Patients will be assessed for eligibility in the Anesthesiology Pre-assessment Clinic of the University Medical Center Hamburg-Eppendorf prior to elective surgery. To rule out a difficult airway prior to study inclusion, all patients receive a structured preoperative airway assessment in accordance with standard operating procedure of the Department of Anesthesiology, University Medical Center Hamburg-Eppendorf using the implemented in-house algorithm for the prediction of difficult airway management and the Simplified Airway Risk Index (SARI). Patients are randomized 1:1 to either intervention or control group. Patients randomized to the intervention group will be intubated with the VSC. Patients randomized to the control group are intubated with a standard MacIntosh type laryngoscope by DL. Anesthesia management, the choice of the blade and tube size, as well as the use of adjuncts like stylets, introducers or forceps or airway optimization maneuvers (e.g. backward upward rightward pressure \[BURP\] and optimum external laryngeal manipulation \[OELM\]) will be left to the discretion of the attending physician. Based on a first attempt success rate of 40%, and a noninferiority margin of 5%, 2x 29 patients are required with errors of α=0.025 and β=0.2 to show non-inferiority for the intervention method (PASS version 08.0.6, NCSS, LLC. Kaysville, UT, USA). All participating physicians are anesthesiology residents or fellows. To avoid a bias that may occur due to different skills for VSC compared to conventional laryngoscopy, physicians participating in this study take part in a 30 min structured manikin airway training before participating in this study. The age and months of work experience of the participating anesthetists will be assessed within a questionnaire.

Conditions

• Airway Management

Interventions

Type	Name	Description
DEVICE	VieScope	see above
DEVICE	Conventional	see above

Timeline

• Start date: 2021-01-26
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2021-01-26
• Last updated: 2021-04-08

Locations

1 site across 1 country: Germany