TRacheal Cuff PRessure Evaluation Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Automated endotracheal cuff controller: The automated endotracheal tube cuff pressure controller will continously assess and maintain the endotracheal tube cuff pressure at pre-specifed pressure level of 25 cmH20.

Study summary

Randomized clinical trial in mechanically ventilate critically ill patients. The study will evaluated the efficacy of a continous endotracheal tube (ETT) cuff pressure controller (TRACH FLUSH group) compared to manual monitoring and inflation (STANDARD group).

Patients intubated, from at least 24 hours and with a predicted duration of invasive mechanical ventilation longer than 72 hours, will be randomized to the use of TRACH FLUSH versus nurse operated analogic cuff pressure controller q8.

Hypotesis of the study is the superiority of the continuous cuff pressure controller in maintaining cuff pressure within the target value, thus decreasing the incidence of microaspiration events.

Aim of the study are 1) to compare the incidence of cuff pressure value detection outside the target range between the TRACH FLUSH and the STANDARD group, and 2) to compare the incidence of sputum samples positive for (amylase and/or pepsin), a surrogate for tracheal micro-aspiration event.

Eligibility

Primary outcome measure(s)

• Cuff Pressure — From enrollment to either the 5th day of invasive mechanical ventilation, or discontinuation of invasive mechanical ventilation
  Incidence of measurements with a endotracheal cuff pressure outside the prespecified target value: 25 cmH2O

Trial sites (1)

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