VieScope Versus Direct Laryngoscopic Intubation (VieScOP)

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

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.

Study Overview

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

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.

• 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 non-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 Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VieScope; intubation with the VieScope laryngoscope	Device: VieScope; see above
Active Comparator: Conventional; intubation with MacIntosh-type laryngoscope	Device: Conventional; see above

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First attempt success rate	percentage of successful intubations with one attempt	15 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intubating conditions	grades according to Cormack-Lehane and POGO	15 min
overall success rate	percentage of successful intubations with the allocated procedure	15 min
time to successful intubation	time until an endotracheal airway access is established	15 min
time to successful intubation with one attempt	time until an endotracheal airway access is established in patients that are intubated at first attempt	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
end-tidal carbondioxide fraction	the highest end-tidal carbondioxide fraction in the exspiratory gas within two minutes after successful intubation	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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: January 23, 2021
• First Submitted That Met QC Criteria: January 23, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: VieScOP

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