Comparing two methods for intubation in patients with difficult airways
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
This study is testing whether a new flexible tip tool can help doctors successfully intubate patients with difficult airways on the first try, compared to a traditional method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Hospital Clinico Universitario de Santiago Academic / other |
| Locations | 1 site (Santiago de Compostela, A Coruña) |
| Trial ID | NCT05429125 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of a new flexible tip bougie against a traditional endotracheal tube with stylet for intubation using videolaryngoscopy in patients who are expected to have difficult airways. The flexible tip bougie is designed to navigate sharp angles more easily, potentially improving the success rate of intubation on the first attempt. Participants will be randomly assigned to receive either the flexible tip bougie or the endotracheal tube with stylet during awake intubation. The study will assess the success of intubation on the first attempt in both groups.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are anticipated to have a difficult airway requiring intubation with videolaryngoscopy.
Not a fit: Patients who are pregnant, under 18 years old, or experiencing respiratory failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the success rate of intubation in patients with difficult airways.
How similar studies have performed: While there have been studies on intubation techniques, the specific use of the flexible tip bougie in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Santiago de Compostela, A Coruña
- University Clinical Hospital of Santiago de Compostela — Santiago de Compostela, A Coruña, Spain (Recruiting)
Study contacts
- Principal investigator: Manuel Taboada Muñiz, Ph.D. — University Clinical Hospital of Santiago de Compostela
- Study coordinator: Manuel Taboada Muñiz, Ph.D.
- Email: manutabo@yahoo.es
- Phone: 0034-981950674
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.