VieScope in Patients With an Expected Difficult Airway

Tracheal Intubation With VieScope Versus Videolaryngoscopy in Patients for Elective Surgery With an Expected Difficult Airway - a Prospective Randomized Trial (VieScOP-II)

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

Study Overview

• Status: Completed
• Conditions: Airway Management
• Intervention / Treatment: Device: VieScope; Device: 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).

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • HH
    • Hamburg, HH, Germany, 20246
      • Universitätsklinikum Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: VieScope; intubation with the VieScope laryngoscope	Device: VieScope; intubation with VieScope laryngoscope
ACTIVE_COMPARATOR: Videolaryngoscopy; intubation with videolaryngoscope	Device: Videolaryngoscopy; intubation with videolaryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Glottis Opening (POGO) scale	intubating conditions according to the percentage of glottis opening scale (POGO), range 0-100%, higher values better	15 min

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 11, 2021
• Primary Completion (ACTUAL): June 26, 2022
• Study Completion (ACTUAL): June 26, 2022

Study Registration Dates

• First Submitted: September 5, 2021
• First Submitted That Met QC Criteria: September 5, 2021
• First Posted (ACTUAL): September 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: VieScOP-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No