Tracheal Intubation With VieScope Versus Videolaryngoscopy in Patients for Elective Surgery With an Expected Difficult Airway - a Prospective Randomized Trial (VieScOP-II)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Airway Management
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Percentage of Glottis Opening (POGO) scale
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients requiring general anesthesia with transoral tracheal intubation for elective surgery
- •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
Outcomes
Primary Outcomes
Percentage of Glottis Opening (POGO) scale
Time Frame: 15 min
intubating conditions according to the percentage of glottis opening scale (POGO), range 0-100%, higher values better
Secondary Outcomes
- time to intubation(15 min)
- first attempt success rate(15 min)
- Cormack-Lehane(15 min)
- overall success rate(15 min)
- hypotension(15 min)
- hypoxia(15 min)
- intubation difficulty(15 min)
- esophageal intubation(15 min)
- time to successful intubation with one attempt(15 min)
- number of attempts(15 min)
- aspiration(15 min)