C-MAC Videolaryngoscopy Versus Direct Laryngoscopy for Percutaneous Tracheostomy

Percutaneous Tracheostomy Clinical Trial

— VIDLARTRAQ  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05416489
• Other study ID #: VIDLARTRAQUEO
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Hospital Clinico Universitario de Santiago
• Contact: Manuel Taboada, Ph.D.
• Phone: 0034981950674
• Email: manutabo[@]yahoo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intubated Patients
• Percutaneous Tracheostomy

Intervention

Device:
• C-MAC videolayngoscopy technique
Endotracheal tube will be removed before percutaneous tracheostomy using a C-MAC videolaryngoscopy.
• Laryngoscopy technique
Endotracheal tube will be removed before percutaneous tracheostomy using a laryngoscopy

Locations

Country	Name	City	State
Spain	University Clinical Hospital of Santiago de Compostela	Santiago de Compostela	A Coruña
Spain	University Clinical Hospital of Santiago de Compostela	Santiago de Compostela	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinico Universitario de Santiago

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Complications	Percentage of complications	during the ICU stay