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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000891426
Enrollment
95
Registered
2016-07-06
Start date
2016-04-22
Completion date
2018-06-01
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

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.

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 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 we

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

Sponsors

University Malaya Medical Centre
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

All staff nurses working in the ICU and fulfill the inclusion criteria for nurses: (i) had more than six months working experience in critical care units and (ii) willingness to participate. Patients who will be included are: All adult ICU patients above 18 years old who are intubated with an orotracheal tube or tracheostomy tube.

Exclusion criteria

Nurses with less than 6 months of experience in ICU Unwillingness to participate Patient's 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

None listed

Source: ANZCTR · Data processed: Feb 4, 2026