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C-MAC Videolaryngoscopy Versus Direct Laryngoscopy for Percutaneous Tracheostomy

Videolaryngoscopy Versus Direct Laryngoscopy for Positioning the Tracheal Tube During Percutaneous Tracheostomy: A Randomized Controlled Trial (VIDLARTRAQUEO).

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05416489
Acronym
VIDLARTRAQ
Enrollment
90
Registered
2022-06-13
Start date
2022-01-01
Completion date
2026-06-30
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubated Patients, Percutaneous Tracheostomy

Keywords

Tracheostomy, Critical care, Videolaryngoscopy, Direct laryngoscopy, Airway management

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.

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

DEVICEC-MAC videolayngoscopy technique

Endotracheal tube will be removed before percutaneous tracheostomy using a C-MAC videolaryngoscopy.

DEVICELaryngoscopy technique

Endotracheal tube will be removed before percutaneous tracheostomy using a laryngoscopy

Sponsors

Hospital Clinico Universitario de Santiago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized, controlled.

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Introduction of the Seldinger needle below the endotracheal tubeduring the procedurePercentage of patients in whom the introduction of the Seldinger needle is below the tip of the endotracheal tube

Secondary

MeasureTime frameDescription
Puncture of the cuff of the endotracheal tube with the Seldinger needleduring the procedurePercentage of patients suffering puncture the cuff of the endotracheal tube with the Seldinger needle
patients who need to remove the endotracheal tube to introduce the percutaneous tracheostomy cannuladuring the procedurePercentage of patients who need to remove the endotracheal tube to introduce the percutaneous tracheostomy cannula
Laryngoscopy vision using de Modified Cormack-Lehane grade of glottic viewduring the procedureDifferences in laryngoscopy vision using de modified Cormack-Lehane grade of glottic view Modified Cormack-Lehane grade of glottic view: I: full view of the glottis (better outcome) 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 (worse outcome)
Difficulty of performing percutaneous tracheotomyduring the procedureDifferences in the difficulty of performing percutaneous tracheotomy Operator-assessed subjective difficulty of performing percutaneous tracheotomy: No difficulty, mild difficulty, moderate difficulty, severe difficulty.
Complicationsduring the ICU stayPercentage of complications
Difficulty of removing the endotracheal tubeduring the procedureDifferences in the difficulty of removing the endotracheal tube due to poor visualization, secretions.... Operator-assessed subjective difficulty of removing the endotracheal tube: No difficulty, mild difficulty, moderate difficulty, severe difficulty.

Countries

Spain

Contacts

Primary ContactManuel Taboada, Ph.D.
manutabo@yahoo.es0034981950674

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026