NCT05416489 C-MAC Videolaryngoscopy Versus Direct Laryngoscopy for Percutaneous Tracheostomy
| NCT ID | NCT05416489 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Clinico Universitario de Santiago |
| Condition | Intubated Patients |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2022-01-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
When preparing an ICU patient for percutaneous dilational tracheostomy, correct positioning of the endotracheal tube is important. During the procedure, it is possible to puncture the cuff. Tracheal tube cuff puncture can lead to failure of ventilation, loss of positive end-expiratory pressure, and possible aspiration of gastric contents blood or secretions. To minimize the risk, in our ICU, we withdraw the endotracheal tube under direct laryngoscopic vision until the cuff is visible at the vocal cords. This maneuver would also facilitate insertion of the Seldinger needle and insertion of the tracheostomy tube below the endotracheal tube. However, this maneuver to remove the endotracheal tube under direct laryngoscopy can sometimes be difficult. ICU patients present frecuently difficult laryngoscopic vision due to airway edema or secretions. In ICU, the videolaryngopy has been shown to be superior to direct laryngoscopy in visualization the upper airway, allowing better laryngoscopic vision.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05416489 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Intubated Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05416489 currently recruiting?
Yes, NCT05416489 is actively recruiting participants. Contact the research team at manutabo@yahoo.es for enrollment information.
Where is the NCT05416489 trial being conducted?
This trial is being conducted at Santiago de Compostela, Spain, Santiago de Compostela, Spain.
Who is sponsoring the NCT05416489 clinical trial?
NCT05416489 is sponsored by Hospital Clinico Universitario de Santiago. The trial plans to enroll 90 participants.