Flexible Tip Bougie vs Tube With Stylet for Intubation With Videolaryngoscopy.

Intubation; Difficult or Failed Clinical Trial

— VIFLEXTIPOR  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05429125
• Other study ID #: VIDEOLAR-FLEXTIP-OR
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Hospital Clinico Universitario de Santiago
• Contact: Manuel Taboada Muñiz, Ph.D.
• Phone: 0034-981950674
• Email: manutabo[@]yahoo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Intubation; Difficult or Failed

Intervention

Device:
• Endotracheal Tube with Stylet
Patients randomised to Endotracheal Tube with Stylet will be intubated with a Videolaryngoscopy and with an endotracheal tube + stylet.
• Flexible Tip Bougie
Patients randomised to Flexible Tip Bougie will be intubated with a Videolaryngoscopy and with a Flexible Tip Bougie.

Locations

Country	Name	City	State
Spain	University Clinical Hospital of Santiago de Compostela	Santiago de Compostela	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinico Universitario de Santiago

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the first attempt intubation success rate (percentage)	To compare the difference in the first attempt intubation success rate (percentage) with the two differents devices compared.	During intubation
Secondary	Difference in the overall intubation success rate (percentage)	To compare the difference overall intubation success rate (percentage) with the two differents devices compared.	During intubation
Secondary	Difference in the incidence of complications (percentage)	To compare the difference in complications (percentage) with the two different devices compared: Hypoxemia (SpO2) < 90 %, Hypoxemia severe (SpO2) < 80 %, Hypotension defined as systolic blood pressure less than 80 mm Hg, Severe hypotension defined as systolic blood pressure less than 65 mm Hg, Cardiac arrest, death during intubation, Moderate or difficult intubation, oesophageal intubation, pulmonary aspiration, dental injuries.	Participants will be followed from the beginning of the intervention to 30 minutes after the intervention
Secondary	Difficulty of intubation	Operator-assessed subjective difficulty of intubation by means of a special analogue numerical scale from 0 to 10, where 0=no subjective difficulty and 10=maximal subjective difficulty	During intubation
Secondary	Modified Cormack-Lehane grade of glottic view	Modified Cormack-Lehane grade of glottic view: I: full view of the glottis IIa: partial view of the glottis IIb: arytenoid or posterior part of the vocal cords just visible III: only epiglottis visible IV: neither glottis nor epiglottis visible	During intubation
Secondary	Additional airway equipment	Need for additional airway equipment	During intubation
Secondary	Number of intubation attempts	Number of intubation attempts	During intubation