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

NCT05429125 | Recruiting

• 1 other identifier: VIDEOLAR-FLEXTIP-OR
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation; Difficult or Failed

Keywords

intubation; difficult airway; videolaryngoscope; operating room; Awake intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Difference in the overall intubation success rate (percentage)

  During intubation

• Difference in the incidence of complications (percentage)

  Participants will be followed from the beginning of the intervention to 30 minutes after the intervention

• Difficulty of intubation

  During intubation

• Modified Cormack-Lehane grade of glottic view

  During intubation

• Additional airway equipment

  During intubation

Study Arms (2)

Endotracheal Tube with Stylet

ACTIVE COMPARATOR

Patients randomised to Endotracheal Tube with Stylet will be intubated with a Videolaryngoscopy and with an endotracheal tube + stylet.

Device: Endotracheal Tube with Stylet

Flexible Tip Bougie

ACTIVE COMPARATOR

Patients randomised to Flexible Tip Bougie will be intubated with a Videolaryngoscopy and with a Flexible Tip Bougie.

Device: Flexible Tip Bougie

Interventions

Endotracheal Tube with Stylet DEVICE

Patients randomised to Endotracheal Tube with Stylet will be intubated with a Videolaryngoscopy and with an endotracheal tube + stylet.

Endotracheal Tube with Stylet

Flexible Tip Bougie DEVICE

Patients randomised to Flexible Tip Bougie will be intubated with a Videolaryngoscopy and with a Flexible Tip Bougie.

Flexible Tip Bougie

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Patients with anticipated difficult airway requiring intubation under with a videolaryngoscopy

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead

Study Sites (1)

University Clinical Hospital of Santiago de Compostela

Santiago de Compostela, A Coruña, 15866, Spain

RECRUITING

Related Publications (2)

• 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.

  PMID: 32312225 BACKGROUND

• 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.

  PMID: 29800096 BACKGROUND

Study Officials

• Manuel Taboada Muñiz, Ph.D.

  University Clinical Hospital of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel Taboada Muñiz, Ph.D.

CONTACT

0034-981950674; manutabo@yahoo.es

Manuel Taboada Muñiz, Ph.D.

CONTACT

678195618; manuel.taboada.muniz@sergas.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 23, 2022
• Study Start: June 17, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: When available: With publication
• Access Criteria: Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose

Locations

ES (1)