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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Automated endotracheal cuff controller
DeviceThe automated endotracheal tube cuff pressure controller will continously assess and maintain the endotracheal tube cuff pressure at pre-specifed pressure level of 25 cmH20.
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: Automated endotracheal cuff controllerExperimental treatment 1 intervention
Group B: Control group (analogic manometer)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Cuff Pressure
Incidence of measurements with a endotracheal cuff pressure outside the prespecified target value: 25 cmH2O
Time frame
From enrollment to either the 5th day of invasive mechanical ventilation, or discontinuation of invasive mechanical ventilationSecondary outcomes
1
Microaspiration
Incidence of detection of detectable levels of Pepsin A and Amylase in the tracheal secretions samples. Daily sampling of tracheal secretions will be performed at 8:00AM.
Time frame
From enrollment to either the 5th day of invasive mechanical ventilation, or discontinuation of invasive mechanical ventilationSponsors and contacts
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Source ClinicalTrials.gov
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