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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05429112
Other study ID # VIDEOLAR-FLEXTIP-ICU
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 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
Health authority
Study type Interventional

Clinical Trial Summary

Tracheal intubation in the intensive care unit (ICU) is associated with high incidence of difficult intubation and complications . Videolaryngoscopes (VLs) devices have been proposed to improve airway management, and the use of VLs are recommended as first-line or after a first-attempt failure using direct laryngoscopy in ICU airway management algorithms. Although two meta-analysis showed that videolaryngoscopy improves visualization of the glottis and the first-attempt success, other two meta-analysis reported that videolaryngoscopy didn´t improve first-attempt success rate. The reason may be that 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 .


Description:

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. The purpose of this prospective randomized study is to compare successful intubation on the first attempt wuth the new flexible tip bougie versus endotracheal tube with stylet during intubation with videolaryngoscopy of critically ill adults in ICU.


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 85 Years
Eligibility Inclusion Criteria: - Patients admitted in the intensive care unit (ICU) and require mechanical ventilation through a tracheal tube. - Adult (age = 18 years) - 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: - Refusal of study participation or to pursue the study by the patient - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

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

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 (4)

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

Driver BE, Semler MW, Self WH, Ginde AA, Trent SA, Gandotra S, Smith LM, Page DB, Vonderhaar DJ, West JR, Joffe AM, Mitchell SH, Doerschug KC, Hughes CG, High K, Landsperger JS, Jackson KE, Howell MP, Robison SW, Gaillard JP, Whitson MR, Barnes CM, Latimer AJ, Koppurapu VS, Alvis BD, Russell DW, Gibbs KW, Wang L, Lindsell CJ, Janz DR, Rice TW, Prekker ME, Casey JD; BOUGIE Investigators and the Pragmatic Critical Care Research Group. Effect of Use of a Bougie vs Endotracheal Tube With Stylet on Successful Intubation on the First Attempt Among Critically Ill Patients Undergoing Tracheal Intubation: A Randomized Clinical Trial. JAMA. 2021 Dec 28;326(24):2488-2497. doi: 10.1001/jama.2021.22002. — View Citation

Jaber S, Rolle A, Godet T, Terzi N, Riu B, Asfar P, Bourenne J, Ramin S, Lemiale V, Quenot JP, Guitton C, Prudhomme E, Quemeneur C, Blondonnet R, Biais M, Muller L, Ouattara A, Ferrandiere M, Saint-Leger P, Rimmele T, Pottecher J, Chanques G, Belafia F, Chauveton C, Huguet H, Asehnoune K, Futier E, Azoulay E, Molinari N, De Jong A; STYLETO trial group. Effect of the use of an endotracheal tube and stylet versus an endotracheal tube alone on first-attempt intubation success: a multicentre, randomised clinical trial in 999 patients. Intensive Care Med. 2021 Jun;47(6):653-664. doi: 10.1007/s00134-021-06417-y. Epub 2021 May 25. — 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 success rate (percentage) To compare the difference in the first attempt success rate (percentage) of different techniques for tracheal intubation. during intubation
Secondary Difference in the overall success rate (percentage) To compare the difference overall success rate (percentage) of different techniques for tracheal intubation. during intubation
Secondary Difference in the incidence of complications related to intubation To compare the difference in complications (percentage) of different techniques for tracheal intubation:
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
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