An interventional study of Endotracheal Tube with Stylet and Flexible Tip Bougie in Intubation; Difficult or Failed, sponsored by Hospital Clinico Universitario de Santiago. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-12-31.
Sponsored by Hospital Clinico Universitario de Santiago · Not applicable, Interventional, and Treatment
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 with the new flexible tip bougie versus endotracheal tube with stylet during awake intubation with videolaryngoscopy in patients with anticipated difficult airway.
Hospital Clinico Universitario de Santiago is the lead sponsor of 33 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients randomised to Endotracheal Tube with Stylet will be intubated with a Videolaryngoscopy and with an endotracheal tube + stylet.
Device: Endotracheal Tube with Stylet
Patients randomised to Flexible Tip Bougie will be intubated with a Videolaryngoscopy and with a Flexible Tip Bougie.
Device: Flexible Tip Bougie
Patients randomised to Endotracheal Tube with Stylet will be intubated with a Videolaryngoscopy and with an endotracheal tube + stylet.
Patients randomised to Flexible Tip Bougie will be intubated with a Videolaryngoscopy and with a Flexible Tip Bougie.
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.
Time frame: During intubation
Difference in the overall intubation success rate (percentage)
To compare the difference overall intubation success rate (percentage) with the two differents devices compared.
Time frame: During intubation
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.
Time frame: Participants will be followed from the beginning of the intervention to 30 minutes after the intervention
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
Time frame: During intubation
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
Time frame: During intubation
Additional airway equipment
Need for additional airway equipment
Time frame: During intubation
Number of intubation attempts
Number of intubation attempts
Time frame: During intubation
Plan to share: Yes — Data types: Deidentified participant data How to access data: Requests must be sent to manutabo@yahoo.es When available: With publication Additional Information Who can access the data: Researchers whose proposed use of the data has been approved T ypes of analyses: For scientific purpose Mechanisms of data availability: With investigator support
Supporting information: Study protocol, Sap, Csr
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Hospital Clinico Universitario de Santiago