VieScope in Patients With an Expected Difficult Airway

Universitätsklinikum Hamburg-Eppendorf

Status

Completed

Conditions

Airway Management

Treatments

Device: Videolaryngoscopy

Device: VieScope

Study type

Interventional

Funder types

Other

Identifiers

NCT05044416

VieScOP-II

Details and patient eligibility

About

Patients requiring endotracheal intubation for elective surgery with an expected difficult airway are randomized to be intubated either by a) VieScope or b) videolaryngoscopy.

Full description

Tracheal intubation is required for different surgical procedures for mechanical ventilation and to prevent aspiration of secretions. In patients with an expected difficult airway, tracheal intubation is often performed by videolaryngoscopy (VL). However, 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. We aim to test the VSC in patients compared to videolaryngoscopy in a prospective randomized non-inferiority trial.

Patients will be assessed for eligibility in the Anesthesiology Pre-assessment Clinic of the University Medical Center Hamburg-Eppendorf prior to elective surgery. All patients receive a structured preoperative airway assessment.

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 MacIntosh type videolaryngoscope (CMAC, Storz, Germany).

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients requiring general anesthesia with transoral tracheal intubation for elective surgery
Age ≥ 18
Preoperative airway assessment reveals an expected difficult airway (rated by the responsible anesthetist in the Pre-assessment Clinic based on the existing in-house algorithm)

Exclusion criteria

Pregnant or breastfeeding woman
Confirmed indications for awake fiberoptic intubation especially due to enoral, pharyngeal tumors, abscesses or other processes
Planned endotracheal intubation without deep anesthesia or neuromuscular blocking agents (e.g. awake videolaryngoscopy)
Required transnasal tracheal intubation (e.g. for surgical reasons)
Requirement of special endotracheal tubes such as laser or RAE tubes for surgical reasons
Patients at risk for pulmonary aspiration who qualify for rapid sequence induction
Loose teeth
Denial of consent