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Trial registered on ANZCTR


Registration number
ACTRN12616000891426
Ethics application status
Approved
Date submitted
25/05/2016
Date registered
6/07/2016
Date last updated
5/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 289290 0
None
Universal Trial Number (UTN)
U1111-1183-1742
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nursing staff managing ventilated patients in ICU 298877 0
Condition category
Condition code
Public Health 298949 298949 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 294841 0
Prevention
Intervention code [2] 295186 0
Treatment: Devices
Comparator / control treatment
The control group will be managed the conventional way - no cuff pressure regulation device will be used and the ETT cuff pressure will be measured every 6 hours using a handheld manometer.
Control group
Active

Outcomes
Primary outcome [1] 298417 0
Nursing knowledge regarding cuff pressure management techniques based on pre and post teaching questionnaire which was specifically designed for this study
Timepoint [1] 298417 0
Assessed prior to teaching sessions and after the conclusion of the study
Primary outcome [2] 298419 0
To compare the efficacy of the Tracoe Smart Cuff Manager as compared to the conventional way of ETT cuff pressure management - ETT cuff pressure will be monitored every 4-6 hourly for each patient. It will be assessed by the number of readings on the manometer which is outside the recommended range (20-30cmH20)
Timepoint [2] 298419 0
ETT cuff pressure will be measured every 4-6hours for all patients throughout the period of intubation or until day 15 of intubation, whichever is longer
Secondary outcome [1] 324075 0
To compare between the 2 groups of patients - developement of post extubation stridor, sore throat and requirement for reintubation (a composite secondary outcome). This will be assessed by observation of the patient post extubation. Patients will also be asked if they are experiencing sore throat.
Timepoint [1] 324075 0
Patients will be assessed for these signs and symptoms post extubation which indicates tracheal mucosal injury

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
A survey method will be used to assess nurses current practice of endotracheal cuff pressure measurement.
· A quasi-experimental approach will be utilized to examine the effect of educational intervention on nurses knowledge and practice of cuff pressure management.
· A qualitative approach will be adopted to explore the nurse’s perception on managing the patient’s endotracheal tube cuff pressure using the traditional method and TRACOE smart cuff manager.

No sample size calculations have been performed as the aim is to educate all nurses in the ICU regarding cuff pressure management

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7897 0
Malaysia
State/province [1] 7897 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 293672 0
Commercial sector/Industry
Name [1] 293672 0
Tracoe Medical
Address [1] 293672 0
TRACOE medical GmbH, Reichelsheimer StraBe 1 / 3, 55268 Nieder-Olm
Country [1] 293672 0
Germany
Primary sponsor type
University
Name
University Malaya Medical Centre
Address
University Malaya Medical Centre, Lembah Pantai, 59100 Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 292504 0
Individual
Name [1] 292504 0
Dr. Vimala A/P Ramoo
Address [1] 292504 0
Department of Nursing Science, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur
Country [1] 292504 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295109 0
Medical Ethics Committee, University Malaya Medical Centre
Ethics committee address [1] 295109 0
Lembah Pantai, 59100 Kuala Lumpur
Ethics committee country [1] 295109 0
Malaysia
Date submitted for ethics approval [1] 295109 0
05/02/2016
Approval date [1] 295109 0
17/02/2016
Ethics approval number [1] 295109 0
20162-2155

Summary
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.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66050 0
Dr Vimala A/P Ramoo
Address 66050 0
Department of Nursing Science, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, MALAYSIA
Country 66050 0
Malaysia
Phone 66050 0
+60379492028
Fax 66050 0
Email 66050 0
vimala@um.edu.my
Contact person for public queries
Name 66051 0
Dr Vimala A/P Ramoo
Address 66051 0
Department of Nursing Science, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, MALAYSIA
Country 66051 0
Malaysia
Phone 66051 0
+60379492028
Fax 66051 0
Email 66051 0
vimala@um.edu.my
Contact person for scientific queries
Name 66052 0
Dr Vimala A/P Ramoo
Address 66052 0
Department of Nursing Science, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, MALAYSIA
Country 66052 0
Malaysia
Phone 66052 0
+60379492028
Fax 66052 0
Email 66052 0
vimala@um.edu.my

No information has been provided regarding IPD availability
Summary results
No Results