VieScope in Patients With an Expected Difficult Airway

NCT ID: NCT05044416

Last Updated: 2022-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-11
• Study Completion Date: 2022-06-26

Brief Summary

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

Detailed 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).

Conditions

Airway Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VieScope

intubation with the VieScope laryngoscope

Group Type: EXPERIMENTAL

VieScope

Intervention Type: DEVICE

intubation with VieScope laryngoscope

Videolaryngoscopy

intubation with videolaryngoscope

Group Type: ACTIVE_COMPARATOR

Videolaryngoscopy

Intervention Type: DEVICE

intubation with videolaryngoscope

Interventions

VieScope

intubation with VieScope laryngoscope

Intervention Type: DEVICE

Videolaryngoscopy

intubation with videolaryngoscope

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joern Grensemann, MD

Role: STUDY_CHAIR

Universitätsklinikum Hamburg-Eppendorf

Martin Petzoldt, MD

Role: STUDY_CHAIR

Universitätsklinikum Hamburg-Eppendorf

Locations

Universitätsklinikum Hamburg-Eppendorf

Hamburg, City state of Hamburg, Germany

Countries

Germany

References

Petzoldt M, Grun C, Wunsch VA, Bauer M, Hardel TT, Grensemann J. Vie Scope(R) versus videolaryngoscopy in expected difficult airways: a randomized controlled trial. Can J Anaesth. 2023 Sep;70(9):1486-1494. doi: 10.1007/s12630-023-02534-y. Epub 2023 Aug 3.

Reference Type: DERIVED

PMID: 37537324 (View on PubMed)

Other Identifiers

VieScOP-II

Identifier Type: -

Identifier Source: org_study_id