C-MAC Videolaryngoscopy Versus Direct Laryngoscopy for Percutaneous Tracheostomy (VIDLARTRAQ)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intubated Patients; Percutaneous Tracheostomy
• Intervention / Treatment: Device: Laryngoscopy technique; Device: C-MAC videolayngoscopy technique

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manuel Taboada, Ph.D.; Phone Number: 0034981950674; Email: manutabo@yahoo.es

Study Locations

• Spain
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15866
      • Recruiting
      • University Clinical Hospital of Santiago de Compostela
      • Contact: Manuel Taboada; Phone Number: Ph.D.; Email: manutabo@yahoo.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional direct laryngoscopy technique; Endotracheal tube will be removed before percutaneous tracheostomy using a traditional direct laryngoscopy technique.	Device: Laryngoscopy technique; Endotracheal tube will be removed before percutaneous tracheostomy using a laryngoscopy
Active Comparator: C-MAC videolaryngoscope technique; Endotracheal tube will be removed before percutaneous tracheostomy using a C-MAC videolaryngoscope technique.	Device: C-MAC videolayngoscopy technique; Endotracheal tube will be removed before percutaneous tracheostomy using a C-MAC videolaryngoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Introduction of the Seldinger needle below the endotracheal tube	Percentage of patients in whom the introduction of the Seldinger needle is below the tip of the endotracheal tube	during the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Puncture of the cuff of the endotracheal tube with the Seldinger needle	Percentage of patients suffering puncture the cuff of the endotracheal tube with the Seldinger needle	during the procedure
patients who need to remove the endotracheal tube to introduce the percutaneous tracheostomy cannula	Percentage of patients who need to remove the endotracheal tube to introduce the percutaneous tracheostomy cannula	during the procedure
Laryngoscopy vision using de Modified Cormack-Lehane grade of glottic view	Differences 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)	during the procedure
Difficulty of removing the endotracheal tube	Differences 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.	during the procedure
Difficulty of performing percutaneous tracheotomy	Differences in the difficulty of performing percutaneous tracheotomy Operator-assessed subjective difficulty of performing percutaneous tracheotomy: No difficulty, mild difficulty, moderate difficulty, severe difficulty.	during the procedure
Complications	Percentage of complications	during the ICU stay

Collaborators and Investigators

• Sponsor: Hospital Clinico Universitario de Santiago

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Videolaryngoscopy; Critical care; Tracheostomy; Airway management; Direct laryngoscopy
• Other Study ID Numbers: VIDLARTRAQUEO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No