VieScope in Patients With an Expected Difficult Airway

Airway Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05044416
• Other study ID #: VieScOP-II
• Status: Completed
• Phase: N/A
• Start date: September 11, 2021
• Est. completion date: June 26, 2022

Study information

• Verified date: June 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 26, 2022
• Est. primary completion date: June 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Management

Intervention

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

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg	HH

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

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