VivaSight-SL Versus Videolaryngoscopy in Expected Difficult Airway
VivaOP
Endotracheal Tube-mounted Camera Assisted Intubation Versus Videolaryngoscopic Intubation in Patients With Expected Difficult Airway - a Prospective Randomized Trial
1 other identifier
interventional
48
1 country
1
Brief Summary
Patients requiring endotracheal intubation for elective surgery with an expected difficult airway are randomized to be intubated either by a) videolaryngoscopy or b) an endotracheal tube-mounted camera.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2020
CompletedFirst Posted
Study publicly available on registry
August 6, 2020
CompletedStudy Start
First participant enrolled
August 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2021
CompletedApril 8, 2021
April 1, 2021
6 months
August 2, 2020
April 7, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
first-pass success
percentage of successful intubations with one attempt
15 minutes
end-tidal oxygen fraction
the lowest end-tidal oxygen fraction within two minutes after successful intubation after a standardized preoxygenation
15 minutes
Secondary Outcomes (11)
overall success rate
15 minutes
time to successful intubation
15 minutes
time to successful intubation with one attempt
15 minutes
intubation difficulty
15 minutes
end-tidal carbondioxide fraction
15 minutes
- +6 more secondary outcomes
Study Arms (2)
VivaSight
EXPERIMENTALIntubated with a VivaSight-SL endotracheal tube.
Conventional
ACTIVE COMPARATORIntubated by videolaryngoscopy.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Hamburg, 20246, Germany
Study Officials
- STUDY CHAIR
Joern Grensemann, MD
Universitätsklinikum Hamburg-Eppendorf
- STUDY CHAIR
Martin Petzoldt, MD
Universitätsklinikum Hamburg-Eppendorf
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- device for intubation may not be blinded for provider or investigator.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2020
First Posted
August 6, 2020
Study Start
August 27, 2020
Primary Completion
February 12, 2021
Study Completion
February 12, 2021
Last Updated
April 8, 2021
Record last verified: 2021-04