Clinical trial NCT05429125: Flexible Tip Bougie vs Tube With Stylet for Intubation With Videolaryngoscopy.
Official title: A Randomized Comparison Between the Flexible Tip Bougie vs Tube With Stylet for First-attempt Intubation Success With the C-MAC Videolaryngoscopy in Patients With Anticipated Difficult Airway
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intubation; Difficult or Failed
Keywords: intubation
difficult airway
videolaryngoscope
operating room
Awake intubation
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although VLs improve glottic visualization, on many occasions it may not be accompanied by intubation at the first attempt, because the endotracheal tube has to pass a sharp angle to enter the trachea. To avoid this limitation, a new flexible tip bougie is designed to flexibly navigate the distal tip and help facilitate precise insertion of the endotracheal tube in the trachea. The flexible tip bougie has an integrated slider along the surface which moves the tip anterior and posterior while the pre-curved distal portion of shaft allows the angulation to provide anterior flexion. This new flexible tip bougie could be used as a rescue when first intubation failure using the videolaryngoscopy, or as a first option to improve the percentage of patients intubated at the first attempt.

Detailed description: The purpose of this prospective randomized study is to compare successful intubation on the first attempt with the new flexible tip bougie versus endotracheal tube with stylet during awake intubation with videolaryngoscopy in patients with anticipated difficult airway.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Patients with anticipated difficult airway requiring intubation under with a videolaryngoscopy
* Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.

Exclusion Criteria:

* Pregnancy
* age \<18 years
* refusal of the patient
* patient's respiratory failure

Primary outcomes:
measure: Difference in the first attempt intubation success rate (percentage)
timeFrame: During intubation
Secondary outcomes:
measure: Difference in the overall intubation success rate (percentage)
timeFrame: During intubation
measure: Difference in the incidence of complications (percentage)
timeFrame: Participants will be followed from the beginning of the intervention to 30 minutes after the intervention
measure: Difficulty of intubation
timeFrame: During intubation
measure: Modified Cormack-Lehane grade of glottic view
timeFrame: During intubation
measure: Additional airway equipment
timeFrame: During intubation
measure: Number of intubation attempts
timeFrame: During intubation
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: University Clinical Hospital of Santiago de Compostela
state: A Coruña
Study officials:
affiliation: University Clinical Hospital of Santiago de Compostela
name: Manuel Taboada Muñiz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruetzler K, Smereka J, Abelairas-Gomez C, Frass M, Dabrowski M, Bialka S, Misiolek H, Plusa T, Robak O, Aniolek O, Ladny JR, Gorczyca D, Ahuja S, Szarpak L. Comparison of the new flexible tip bougie catheter and standard bougie stylet for tracheal intubation by anesthesiologists in different difficult airway scenarios: a randomized crossover trial. BMC Anesthesiol. 2020 Apr 20;20(1):90. doi: 10.1186/s12871-020-01009-7.
citation: Driver BE, Prekker ME, Klein LR, Reardon RF, Miner JR, Fagerstrom ET, Cleghorn MR, McGill JW, Cole JB. Effect of Use of a Bougie vs Endotracheal Tube and Stylet on First-Attempt Intubation Success Among Patients With Difficult Airways Undergoing Emergency Intubation: A Randomized Clinical Trial. JAMA. 2018 Jun 5;319(21):2179-2189. doi: 10.1001/jama.2018.6496.