RecruitingACTRN12616000891426

Effect of endotracheal cuff pressure monitoring and regulation by conventional method using a manometer compared to using a smart cuff manager in intubated Intensive Care Unit patients and nursing outcomes of such practices

Effect of Endotracheal Cuff Pressure Monitoring And Regulation - a comparison between the conventional manometer and Tracoe Smart Cuff Manager in intubated, Intensive Care Unit patients and the nursing outcomes

Sponsor

University Malaya Medical Centre

Enrollment

95 participants

Start Date

Apr 22, 2016

Study Type

Interventional

Conditions

Nursing staff managing ventilated patients in ICU

Summary

It is hypothesised that this study could help to improve the practice of endotracheal cuff pressure management in the intensive care unit. The outcome achieved could lead to the establishment of a standardised practice on cuff pressure management that would enhance quality of patient care. Continuous cuff pressure regulation would be a more cost and time effective way in ensuring the cuff pressure is not under- or over-inflated, hence reducing the risk of VAP and tracheal mucosal injury. It is also hoped that nurses would be able to take a more active role in patient management with appropriate knowledge and skill, and this would enhance patients’ ventilation management and increase patient safety.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two methods of managing the pressure in the cuff (inflatable balloon) of a breathing tube in ICU patients: an intermittent method using a manual pressure gauge checked by nurses at regular intervals, and a continuous automatic method using a device called a Smart Cuff Manager. Keeping the cuff pressure in a safe range prevents airway damage from too much pressure and reduces the risk of pneumonia from too little pressure. This study will also assess nursing knowledge and practices. You may be eligible if: - You are a nurse with more than 6 months of ICU experience who is willing to participate - You are 18 years or older and in the ICU on a breathing tube (endotracheal or tracheostomy tube) You may NOT be eligible if (patients): - You have an upper airway problem - You have chronic or restrictive lung disease - Food or fluids may have been inhaled during intubation - You were ventilated on 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 summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This is an educational intervention on nurses knowledge and practice of endotracheal cuff pressure management The study will be divided into three phases as follows: 1. Phase one involve data c

This is an educational intervention on nurses knowledge and practice of endotracheal cuff pressure management The study will be divided into three phases as follows: 1. Phase one involve data collection on nurses’ knowledge and practice at the pre-intervention level (baseline knowledge) and educational intervention. Nursing continuous education (CNE) sessions will be held where they will be updated regarding latest practices in ETT cuff pressure management. 8 sessions will be held, once a week for an hour for a group of 15-20 nurses. The CNEs will be delivered by a nursing masters student as well as by a representative from Tracoe. Attendance will be taken during each session. The intervention comprises theoretical educational sessions and this will be followed by the introduction of a TRACOE smart cuff manager to maintain continuous cuff pressure. This will include demonstration of skills on cuff pressure monitoring and management using both methods, traditional method and using TRACOE smart cuff manager. 2. Phase two will involve implementation of the TRACOE smart cuff manager compared to the conventional method. Both groups of patients will have their ETT cuff pressure measure 6 hourly. The TRACOE Smart Cuff Manager is a mechanical device, made up of a small elastic balloon inside a plastic shell which can be used to regulate endotracheal tube (ETT) cuff inflation. The Smart Cuff Manager will be attached to the ETT pilot balloon to monitor and regulate the cuff pressure within the acceptable range. Patients will be randomized to the conventional group (ETT cuff pressure monitored using a handheld manometer) or to the TRACOE Smart Cuff Manager group. Both groups will have the ETT cuff pressure monitored every 6 hours until extubation or until day 15 of intubation, whichever is longer. This phase will take approximately 6 months. 3. In phase three, the nurses’ perceptions of the endotracheal cuff management in actual practice will collected using focus group interviews. - 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. Cuff pressure will be measured every 4-6 hours using a handheld manometer. - The control group will be managed the conventional way, with ETT cuff pressures measured every 4 to 6 hours using a handheld manometer

Locations(1)

Kuala Lumpur, Malaysia

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ACTRN12616000891426