RecruitingACTRN12616000817448

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 .

Endotracheal Cuff Pressure Monitoring And Regulation – Continuous (using a Tracoe Smart Cuff Manager) Vs Intermittent Method (using a handheld manometer) to assess the efficacy of the TRACOE smart cuff manager in maintaining continuous endotracheal tube cuff pressure within the normal limit (20 to 30 cm H2O) in critically ill, intubated, adult ICU patients.


Sponsor

University Malaya Medical Centre

Enrollment

68 participants

Start Date

Jul 1, 2016

Study Type

Interventional

Conditions

Summary

This RCT will be conducted to establish the most reliable standard method for optimizing endotracheal tube cuff pressure in an intensive care unit - using the conventional, intermittent method or using a Tracoe Smart Cuff Manager. We hypothesize that the Tracoe Smart Cuff Manager would be able to maintain the endotracheal cuff pressure in it's normal, accepted range more reliably compared to patients who are managed in the conventional way (intermittent measurement using a handheld manometer)


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two methods of monitoring the air pressure in the cuff (small inflatable balloon) of a breathing tube used in patients on a ventilator in intensive care. One method checks the pressure intermittently using a handheld device. The other uses a device called the Tracoe Smart Cuff Manager that monitors and adjusts the pressure continuously and automatically. Keeping the cuff pressure in the right range prevents both airway injury and risk of infection. You may be eligible if: - You are 18 years or older - You are in the intensive care unit and have a breathing tube (endotracheal tube or tracheostomy tube) You may NOT be eligible if: - You have an upper airway problem or abnormality - You have chronic lung disease or a restrictive lung condition - There is reason to believe you may have inhaled food or fluids during intubation - You have been on a ventilator in a general ward for more than 24 hours before ICU admission Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

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

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


Locations(1)

Kuala Lumpur, Malaysia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12616000817448