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

Not Applicable

Recruiting

• Conditions: Intubation; Difficult or Failed
• Interventions: Device: Endotracheal Tube with Stylet; Device: Flexible Tip Bougie

• Registration Number: NCT05429125
• Lead Sponsor: Hospital Clinico Universitario de Santiago

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.

Study Timeline

• Study Start: 2022-06-17
• Study First Submitted: 2022-06-17
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-29
• Last Update Posted: 2024-12-31
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endotracheal Tube with Stylet	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	Flexible Tip Bougie	Patients randomised to Flexible Tip Bougie will be intubated with a Videolaryngoscopy and with a Flexible Tip Bougie.

Primary Outcome Measures

Name	Time	Method
Difference in the first attempt intubation success rate (percentage)	During intubation	To compare the difference in the first attempt intubation success rate (percentage) with the two differents devices compared.

Secondary Outcome Measures

Name	Time	Method
Additional airway equipment	During intubation	Need for additional airway equipment
Difference in the overall intubation success rate (percentage)	During intubation	To compare the difference overall intubation success rate (percentage) with the two differents devices compared.
Difference in the incidence of complications (percentage)	Participants will be followed from the beginning of the intervention to 30 minutes after the intervention	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.
Difficulty of intubation	During 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
Modified Cormack-Lehane grade of glottic view	During intubation	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
Number of intubation attempts	During intubation	Number of intubation attempts

Trial Locations

Locations (1)

University Clinical Hospital of Santiago de Compostela; 🇪🇸 Santiago de Compostela, A Coruña, Spain