Universitätsklinikum Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany
NCT Number: NCT05044416
Patients requiring endotracheal intubation for elective surgery with an expected difficult airway are randomized to be intubated either by a) VieScope or b) videolaryngoscopy.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intubation with VieScope laryngoscope
intubation with videolaryngoscope
Time frame: 15 min
intubating conditions according to the percentage of glottis opening scale (POGO), range 0-100%, higher values better
Time frame: 15 min
percentage of successful intubations with one attempt
Time frame: 15 min
time until tracheal airway access is established
Time frame: 15 min
intubating conditions according to Cormack-Lehane
Time frame: 15 min
percentage of successful intubations with the allocated procedure
Time frame: 15 min
time until tracheal airway access is established in patients that are intubated at first attempt
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
Time frame: 15 min
total number of attempts until airway established
Time frame: 15 min
percentage of patients that vomit and aspirate during intubation
Time frame: 15 min
percentage of accidental esophageal intubation attempts
Time frame: 15 min
percentage of patients with a desaturation below a pulsoximetric saturation of 80%
Time frame: 15 min
percentage of patients with a systolic blood pressure below 70 mmHg
Universitätsklinikum Hamburg-Eppendorf
Other
Tracheal Intubation With VieScope Versus Videolaryngoscopy in Patients for Elective Surgery With an Expected Difficult Airway - a Prospective Randomized Trial (VieScOP-II)
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