VieScope in Patients With an Expected Difficult Airway

Not Applicable

Completed

• Conditions: Airway Management
• Interventions: Device: VieScope; Device: Videolaryngoscopy

• Registration Number: NCT05044416
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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).

Study Timeline

• Study First Submitted: 2021-09-05
• Study First Submitted QC: 2021-09-05
• Study Start: 2021-09-11
• Study First Posted: 2021-09-14
• Status Verified: 2022-06
• Primary Completion: 2022-06-26
• Study Completion: 2022-06-26
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VieScope	VieScope	intubation with the VieScope laryngoscope
Videolaryngoscopy	Videolaryngoscopy	intubation with videolaryngoscope

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
time to intubation	15 min	time until tracheal airway access is established
first attempt success rate	15 min	percentage of successful intubations with one attempt
Cormack-Lehane	15 min	intubating conditions according to Cormack-Lehane
overall success rate	15 min	percentage of successful intubations with the allocated procedure
hypotension	15 min	percentage of patients with a systolic blood pressure below 70 mmHg
hypoxia	15 min	percentage of patients with a desaturation below a pulsoximetric saturation of 80%
intubation difficulty	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
esophageal intubation	15 min	percentage of accidental esophageal intubation attempts
time to successful intubation with one attempt	15 min	time until tracheal airway access is established in patients that are intubated at first attempt
number of attempts	15 min	total number of attempts until airway established
aspiration	15 min	percentage of patients that vomit and aspirate during intubation

Trial Locations

Locations (1)

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, HH, Germany