Endotracheal Tube (ETT) Cuff Pressure Monitoring And Regulation – a comparison between conventional, intermittent monitoring method using a handheld manometer and continuous ETT cuff presure monitoring method using the Tracoe Smart Cuff Manager in an adult Intensive Care Unit setting

Category Primary study
Registry of TrialsANZCTR
Year 2016
INTERVENTION: Patients who are randomized to the TRACOE Smart Cuff Manager group will have their cuffs connected to the Smart Cuff Manager and the balloon will be inflated with air until it is 2/3 to 3/4 (usually 60ml) the volume of the outer shell. They will be monitored until day 2 post extubation or up to day 15 of ICU admission, whichever is longer CONDITION: Patients requiring mechanical ventilation Prevention of microaspiration PRIMARY OUTCOME: Maintainence of the ETT cuff pressures between 20‐30cmH20 using the conventional method or using the Tracoe Smart Cuff Manager. Proportion of time during which the ETT cuff pressure is within the normal limit will be assessed by a handheld manometer measurement taken 6 hourly for all patients. To assess the risk of tracheal mucosal injury in patients with continuous cuff pressure control system versus patients on intermittent cuff pressure monitoring by assessing patient's post extubation ‐ patient will be assessed for hoarseness of voice (judged by medical staff), sore throat and post extubation stridor which could indicate tracheal mucosal injury SECONDARY OUTCOME: To assess the safety and tolerability of the continuous cuff pressure control system ‐ via observation of the patient and from nursing records To compare rates of VAP between the continuous cuff pressure control system and the intermittent cuff pressure monitoring method ‐ patient's will be evaluated daily for VAP ‐ VAP will be diagnosed based on increase in ventilator settings with: ; ‐ hypothermia or hyperthermia or WBC > 12000 or < 4000 cells/mm3 ; ‐ a new antimicrobial agent is started and continued for more than 4 days ; ‐ purulent respiratory secretions or positive culture from respiratory secretions INCLUSION CRITERIA: All adult ICU patients above 18 years old who are intubated with an orotracheal tube or tracheostomy tube.
Epistemonikos ID: 6447cc4b4432db258e6406de5021b27b31c81877
First added on: Aug 25, 2024