TRacheal Cuff PRessure Evaluation Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPoliclinico Hospital

About this trial

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 criteria

Qualifiers

Required invasive mechanical ventilation expected to last for more than 24h

Signed informed consent

Disqualifiers

Intubated from more than 6 hours at the time of screening

Pregnancy

Previous surgery involving the airways

Trial design

Treatments tested in this trial

  • Automated endotracheal cuff controller

Treatment groups

54 Participants
are divided into 2 treatment groups

Sponsors and collaborators