C-MAC Videolaryngoscopy Versus Direct Laryngoscopy for Percutaneous Tracheostomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: C-MAC videolayngoscopy technique, Laryngoscopy technique.
- Who it may be relevant to
- Registry conditions: Intubated Patients, Percutaneous Tracheostomy. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Videolaryngoscopy Versus Direct Laryngoscopy for Positioning the Tracheal Tube During Percutaneous Tracheostomy: A Randomized Controlled Trial (VIDLARTRAQUEO).
Overview
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.
Detailed description
The investigators aim to compare C-MAC videolaryngoscopy versus conventional direct laryngoscopy for positioning the tracheal tube to facilitate insertion of the Seldinger needle and the tracheostomy tube below the endotracheal tube during percutaneous tracheostomy.
Interventions
- Device C-MAC videolayngoscopy technique
Endotracheal tube will be removed before percutaneous tracheostomy using a C-MAC videolaryngoscopy. - Device Laryngoscopy technique
Endotracheal tube will be removed before percutaneous tracheostomy using a laryngoscopy
Primary outcome measures
- Introduction of the Seldinger needle below the endotracheal tube [Time frame: during the procedure]
Secondary outcome measures (6)
- Puncture of the cuff of the endotracheal tube with the Seldinger needle [Time frame: during the procedure]
- patients who need to remove the endotracheal tube to introduce the percutaneous tracheostomy cannula [Time frame: during the procedure]
- Laryngoscopy vision using de Modified Cormack-Lehane grade of glottic view [Time frame: during the procedure]
- Difficulty of removing the endotracheal tube [Time frame: during the procedure]
- Difficulty of performing percutaneous tracheotomy [Time frame: during the procedure]
- Complications [Time frame: during the ICU stay]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 2 centers
- University Clinical Hospital of Santiago de Compostela — Santiago de Compostela
- University Clinical Hospital of Santiago de Compostela — Santiago de Compostela
Publications
- Johnson-Obaseki S, Veljkovic A, Javidnia H. Complication rates of open surgical versus percutaneous tracheostomy in critically ill patients. Laryngoscope. 2016 Nov;126(11):2459-2467. doi: 10.1002/lary.26019. Epub 2016 Apr 14. PMID 27075530
Identifiers
NCT: NCT05416489 · VIDLARTRAQUEO