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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000817448

Enrollment

Registered

2016-06-21

Start date

2016-07-01

Completion date

2018-01-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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)

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 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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

All adult ICU patients above 18 years old who are intubated with an orotracheal tube or tracheostomy tube.

Exclusion criteria

Patients with upper airway pathology Patients with underlying chronic lung disease or restrictive lung disease Patients who may have aspirated during intubation (e.g difficult intubation, food particles in oral cavity during intubation) Patient who are ventilated in the general ward or who have been ventilated in the general ward for more than 24 hours prior to ICU admission.

Outcome results