VieScope in Patients With an Expected Difficult Airway

Overview

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 Title of Study: “Tracheal Intubation With VieScope Versus Videolaryngoscopy in Patients for Elective Surgery With an Expected Difficult Airway – a Prospective Randomized Trial (VieScOP-II)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 31, 2022

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).

Interventions

  • Device: VieScope
    • intubation with VieScope laryngoscope
  • Device: Videolaryngoscopy
    • intubation with videolaryngoscope

Arms, Groups and Cohorts

  • Experimental: VieScope
    • intubation with the VieScope laryngoscope
  • Active Comparator: Videolaryngoscopy
    • intubation with videolaryngoscope

Clinical Trial Outcome Measures

Primary Measures

  • POGO
    • Time Frame: 15 min
    • intubating conditions according to the percentage of glottis opening score (POGO)

Secondary Measures

  • first attempt success rate
    • Time Frame: 15 min
    • percentage of successful intubations with one attempt
  • time to intubation
    • Time Frame: 15 min
    • time until tracheal airway access is established
  • Cormack-Lehane
    • Time Frame: 15 min
    • intubating conditions according to Cormack-Lehane
  • overall success rate
    • Time Frame: 15 min
    • percentage of successful intubations with the allocated procedure
  • time to successful intubation with one attempt
    • Time Frame: 15 min
    • time until tracheal airway access is established in patients that are intubated at first attempt
  • intubation difficulty
    • Time Frame: 15 min
    • subjective rating on a visual analogue scale (0-100, higher values indicate more difficult intubation) of the difficulty of airway management and questionnaire
  • number of attempts
    • Time Frame: 15 min
    • total number of attempts until airway established
  • aspiration
    • Time Frame: 15 min
    • percentage of patients that vomit and aspirate during intubation
  • esophageal intubation
    • Time Frame: 15 min
    • percentage of accidental esophageal intubation attempts
  • hypoxia
    • Time Frame: 15 min
    • percentage of patients with a desaturation below a pulsoximetric saturation of 80%
  • hypotension
    • Time Frame: 15 min
    • percentage of patients with a systolic blood pressure below 70 mmHg

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universitätsklinikum Hamburg-Eppendorf
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joern Grensemann, MD, Study Chair, Universitätsklinikum Hamburg-Eppendorf
    • Martin Petzoldt, MD, Study Chair, Universitätsklinikum Hamburg-Eppendorf
  • Overall Contact(s)
    • Joern Grensemann, MD, +49 152 228 24247, j.grensemann@uke.de

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