Clinical trial NCT02198742: A Comparison Between Two Video Laryngoscopes,in Successfully Intubating Pediatric Mannequins w/wo Difficult Airways
Official title: A Comparison Between Two Video Laryngoscopes,the Truview PCD and the Glidescope Cobalt AVL, in Successfully Intubating Pediatric Mannequins With and Without Difficult Airways
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Intubation; Difficult
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study is a randomized crossover study where anesthesia practitioners will intubate three different pediatric infant mannequins (normal airway, anterior larynx, Pierre Robin syndrome anatomy) using three different intubation devices (the Miller blade, the Truview VL, the Glidescope Cobalt video-laryngoscope) in two different scenarios (normal neck and with an immobile neck). The order of presentation will be randomized. As this is a cross over study, all subjects will complete all scenarios. There is no placebo group, and each subject wil be his or her own control.

Detailed description: Participants will be given individual, standardized instructions and demonstrations for each device as per the manufacturers' instructions. The participants will practice with instructor's feedback on an infant mannequin with a normal airway until he/she feel comfortable with each of the three devices. The investigator will record the prior experience of the participant in using each of the 3 devices in clinical situations. Each subject will be asked to intubate each of the mannequins with each of the devices. The choice of the order of device and mannequin will be based on a Latin square design and the sequence will be assigned to participants based on a computer generated random number. A closed envelope technique will blind participants and investigators to the order of airway device and mannequin till the start of the individual trial. Participants will first finish the test on unchanged conditions and then repeat the process using the same order of mannequins and devices but with the neck held immobile to simulate a scenario of a child with an unstable cervical spine. Data from different scenarios will be recorded from a total number of 18 attempts of tracheal intubation per participant. Participants will be asked to proceed as though they were in the operating room with an assistant available to follow their commands. The order of presentation of each mannequin, airway device and scenario will be randomized as described above. The time from placing the device in the mannequin's mouth to the time the Ambu bag is connected to the end of the tracheal tube and a positive pressure breath is given will constitute the intubation time. During each intubation the participant will be asked to state when he or she has obtained the best view for intubation and this time this will be recorded as the time for visualization. The subject will assess the quality of the best glottic view on the Cormack - Lehane grade of 1 -4. The investigators will record all maneuvers to optimize visualization of the larynx such as tracheal pressure, lip retraction, pulling the tongue forward etc. The time from entry of the device in the mouth to the time the tracheal tube is started to be advanced is the visualization time. The time a positive pressure breath is given at the end of the tracheal tube will constitute the end of the attempt of intubation. A failed attempt is defined as removal of the laryngoscope from the mouth without a successful intubation. The number of times the endotracheal tube is advanced will also be recorded. Failure of intubation will be defined as unrecognized esophageal intubation, abandoned procedure, intubation taking longer than 120 seconds and intubation requiring more than 3 attempts. The observer will estimate the maximum force applied to the maxilla on a 0 -10 scale where 0= no force and 10 = maximum force with distortion of the maxilla. The observer will also estimate potential damage of laryngeal structures on a 0 -10 scale.

Eligibility criteria: Inclusion Criteria:

* Anesthesia practitioners including anesthesia attendings, fellows, residents CAIII and CRNA's at Texas Children's Hospital Department of Anesthesiology with clinical experience of \>500 intubations with Miller blades.

Exclusion Criteria:

* Anesthesia practitioners with \<500 intubations with Miller blades.

Primary outcomes:
measure: Time required for successful endotracheal intubation with the three devices.
timeFrame: Subjects complete study in 1 day
Secondary outcomes:
measure: Time to visualize the larynx
timeFrame: From time recorder says "begin" till subject rates best view up to 3minutes
measure: Time from visualization of larynx to tracheal intubation
timeFrame: one day
measure: Number of attempts at tracheal intubation
timeFrame: one day
measure: Number of failed attempts
timeFrame: one day
measure: Amount of force on the maxilla
timeFrame: one day
measure: Optimization measures for laryngeal visualization and tracheal intubation
timeFrame: one day
measure: Documentation of participant's comments on preference of device
timeFrame: one day
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children't Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Helena Karlberg, MD
role: PRINCIPAL_INVESTIGATOR
References: