C-MAC Videolaryngoscopy Versus Direct Laryngoscopy for Percutaneous Tracheostomy

NCT05416489 | Recruiting DMC

• 1 other identifier: VIDLARTRAQUEO
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Intubated Patients; Percutaneous Tracheostomy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Puncture of 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

  during the procedure

• Laryngoscopy vision using de Modified Cormack-Lehane grade of glottic view

  during the procedure

• Difficulty of removing the endotracheal tube

  during the procedure

• Difficulty of performing percutaneous tracheotomy

  during the procedure

Study Arms (2)

Traditional direct laryngoscopy technique

ACTIVE COMPARATOR

Endotracheal tube will be removed before percutaneous tracheostomy using a traditional direct laryngoscopy technique.

Device: Laryngoscopy technique

C-MAC videolaryngoscope technique

ACTIVE COMPARATOR

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

Device: C-MAC videolayngoscopy technique

Interventions

C-MAC videolayngoscopy technique DEVICE

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

C-MAC videolaryngoscope technique

Laryngoscopy technique DEVICE

Endotracheal tube will be removed before percutaneous tracheostomy using a laryngoscopy

Traditional direct laryngoscopy technique

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ICU intubated patients that require a percutaneous dilational tracheostomy for clinical reasons (prolonged mechanical ventilation, airway protection or weaning failure).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead

Study Sites (2)

University Clinical Hospital of Santiago de Compostela

Santiago de Compostela, A Coruña, 15866, Spain

RECRUITING

University Clinical Hospital of Santiago de Compostela

Santiago de Compostela, A Coruña, 15866, Spain

RECRUITING

Related Publications (1)

• 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 BACKGROUND

Central Study Contacts

Manuel Taboada, Ph.D.

CONTACT

0034981950674; manutabo@yahoo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Randomized, controlled.

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: June 13, 2022
• Study Start: January 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)