Comparing videolaryngoscopy and direct laryngoscopy for tracheostomy procedures
Videolaryngoscopy Versus Direct Laryngoscopy for Positioning the Tracheal Tube During Percutaneous Tracheostomy: A Randomized Controlled Trial (VIDLARTRAQUEO).
This study is testing whether a new video-assisted method for placing a breathing tube is easier and safer for patients in the ICU who need a tracheostomy compared to the traditional method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Hospital Clinico Universitario de Santiago Academic / other |
| Locations | 2 sites (Santiago de Compostela, A Coruña and 1 other locations) |
| Trial ID | NCT05416489 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of C-MAC videolaryngoscopy against conventional direct laryngoscopy in positioning the tracheal tube for patients undergoing percutaneous dilational tracheostomy. The focus is on improving visualization of the airway to facilitate the insertion of the Seldinger needle and tracheostomy tube. The study will involve ICU patients who are intubated and require this procedure for clinical reasons such as prolonged mechanical ventilation. The investigators will assess the outcomes related to the ease of the procedure and potential complications.
Who should consider this trial
Good fit: Ideal candidates are ICU intubated patients aged 18 to 85 who require a percutaneous dilational tracheostomy.
Not a fit: Patients with neck abnormalities, infections, or coagulation disorders, as well as those who refuse consent, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the safety and effectiveness of tracheostomy procedures in critically ill patients.
How similar studies have performed: Previous studies have indicated that videolaryngoscopy may provide superior visualization compared to direct laryngoscopy, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ICU intubated patients that require a percutaneous dilational tracheostomy for clinical reasons (prolonged mechanical ventilation, airway protection or weaning failure). Exclusion Criteria: * Patients younger than 18 years and older than 85 years * Trachea and neck abnormalities. * Soft tissue infection in the neck. * History of neck surgery. * Coagulation disorders or changes in coagulation parameters (platelet count \< 50.000 mm3, an activated partial thromboplastin time 1.5-fold longer than the control value, and international normalized ratio \> 1.5). * Consent refusal for participating in the trial.
Where this trial is running
Santiago de Compostela, A Coruña and 1 other locations
- University Clinical Hospital of Santiago de Compostela — Santiago de Compostela, A Coruña, Spain (Recruiting)
- University Clinical Hospital of Santiago de Compostela — Santiago de Compostela, A Coruña, Spain (Recruiting)
Study contacts
- Study coordinator: Manuel Taboada, Ph.D.
- Email: manutabo@yahoo.es
- Phone: 0034981950674
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.