Efficacy Study of a Novel Device to Clean the Endotracheal Tube
Condition: Endotracheal Extubation; Airway Obstruction; Airway Control; Pneumonia, Ventilator-Associated; Breathing Mechanics
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated; Airway Obstruction
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the in-vivo efficacy of a novel device (endOclear)
      for cleaning the endotracheal tube (ETT) lumen from secretions. The investigators hypothesize
      that a protocol of routine ETT cleaning with endOclear may increase the ETT luminal volume
      measured at extubation compared to the current standard of care. The device may therefore be
      clinically useful by better maintaining the ETT original function.
    

Detailed description: 
      After a few days of mechanical ventilation (MV), the lumen of the endotracheal tube (ETT) is
      coated with a thick bacterial biofilm, which is a potential source for bacterial colonization
      of the lower respiratory tract and ventilator-associated pneumonia (VAP). Accumulation of
      mucus/secretions on the interior of the ETT also effectively lowers the cross section of the
      ETT and increases significantly the work of breathing in intubated patients, who then require
      increased MV support, with prolonged intubation and ICU stay.

      A primary goal for all ICUs is to shorten the time of MV, to decrease the incidence of ETT
      microbial colonization and ultimately VAP incidence. To meet this goal several airways
      technologies to maintain the ETT free from debris/bacteria have been developed in order to
      improve the current ventilator-liberation standards in intubated critically ill patients.

      Based on preliminary laboratory, animal and clinical data, The investigators now wish to test
      the hypothesis that a novel commercially available ETT cleaning device can be effective in
      targeting two specific issues:

        -  Specific aim 1: To evaluate the mean difference in ETT luminal volume of ETTs cleaned
           with the novel cleaning device (EndOclear) vs. ETT cleaned in the standard manner.

        -  Specific aim 2: To determine whether ETTs cleaned with the novel device show a lower
           degree of microbial colonization for the entire period of mechanical ventilation.

      Data about in-vivo respiratory mechanics measurements, microbial diversity and antibiotic
      resistance analysis, users' feedbacks and safety of the device will also be collected.

      The investigators will conduct a clinical trial on 74 intubated patients randomized to
      receive standard ETT cleaning or cleaning with the EndOclear.
    

Intervention name(s): ETT cleaning maneuver
Intervention type(s): Device
Intervention description(s): EndOclear device will be used for ETT cleaning maneuver. This is a commercially available device. It consists of an ETT cleaning apparatus with a flexible central tube and a cleaning device at its distal end. The cleaning device has a mechanically expandable mesh structure which can be adapted to selectively move between a radially-collapsed position and a radially-expanded one. In operation, the collapsed cleaning apparatus is inserted into the ETT through a Y-shaped connector. The device is then expanded by a safety toggle protected trigger mechanism that, when fired, presses the device's smooth silicone disc against the inside surface of the ETT. The cleaning apparatus is then pulled out of the ETT removing mucus deposits and secretions.
We will add endOclear to the standard ICU practice, scheduling the systematic use of the device every 8 hours for the whole intubation period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Medical Devices; Ventilator-Associated Pneumonia (VAP); Ventilator-Associated Events (VAE); Endotracheal Tube; Microbial Diversity; Anti-Resistance; Computed Tomography (CT)