C-MAC Videolaryngoscopy Versus Direct Laryngoscopy for Percutaneous Tracheostomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorHospital Clinico Universitario de Santiago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ICU intubated patients that require a percutaneous dilational tracheostomy for clinical reasons (prolonged mechanical ventilation, airway protection or weaning failure).
Disqualifiers
Patients younger than 18 years and older than 85 years
Trachea and neck abnormalities.
Soft tissue infection in the neck.
History of neck surgery.
Trial design
Design model
Parallel
Treatments tested in this trial
C-MAC videolayngoscopy technique
DeviceEndotracheal tube will be removed before percutaneous tracheostomy using a C-MAC videolaryngoscopy.
Laryngoscopy technique
DeviceEndotracheal tube will be removed before percutaneous tracheostomy using a laryngoscopy
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Traditional direct laryngoscopy techniqueActive comparator 1 intervention
Group B: C-MAC videolaryngoscope techniqueActive comparator 1 intervention
Trial outcomes
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
Time frame
during the procedureSecondary outcomes
1
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
Time frame
during the procedure2
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
Time frame
during the procedure3
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)
Time frame
during the procedure4
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.
Time frame
during the procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov