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Trial registered on ANZCTR


Registration number
ACTRN12616000817448
Ethics application status
Approved
Date submitted
10/05/2016
Date registered
21/06/2016
Date last updated
5/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
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
.
Scientific title
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.
Secondary ID [1] 289022 0
Nil known
Universal Trial Number (UTN)
U1111-1182-0138
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients requiring mechanical ventilation 298437 0
Prevention of microaspiration 298438 0
Condition category
Condition code
Anaesthesiology 298534 298534 0 0
Other anaesthesiology
Respiratory 298885 298885 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 294506 0
Prevention
Intervention code [2] 294862 0
Treatment: Devices
Comparator / control treatment
The control group will be managed the conventional way, with ETT cuff pressures measured every 4 to 6 hours
Control group
Active

Outcomes
Primary outcome [1] 298353 0
Maintainence of the ETT cuff pressures between 20-30cmH20 using the conventional method or using the Tracoe Smart Cuff Manager. Proportion of time during which the ETT cuff pressure is within the normal limit will be assessed by a handheld manometer measurement taken 6 hourly for all patients.
Timepoint [1] 298353 0
Throughout the patient's intubation period or up to day 15 of intubation, whichever is longer
Primary outcome [2] 298447 0
To assess the risk of tracheal mucosal injury in patients with continuous cuff pressure control system versus patients on intermittent cuff pressure monitoring by assessing patient's post extubation - patient will be assessed for hoarseness of voice (judged by medical staff), sore throat and post extubation stridor which could indicate tracheal mucosal injury
Timepoint [2] 298447 0
After extubation of patient
Secondary outcome [1] 324151 0
To assess the safety and tolerability of the continuous cuff pressure control system - via observation of the patient and from nursing records
Timepoint [1] 324151 0
Throughout patient's intubation period or up to day 15 of intubation, whichever is longer
Secondary outcome [2] 324152 0
To compare rates of VAP between the continuous cuff pressure control system and the intermittent cuff pressure monitoring method - patient's will be evaluated daily for VAP - VAP will be diagnosed based on increase in ventilator settings with:
- hypothermia or hyperthermia or WBC > 12000 or < 4000 cells/mm3
- a new antimicrobial agent is started and continued for more than 4 days
- purulent respiratory secretions or positive culture from respiratory secretions
Timepoint [2] 324152 0
Up to 48 hours post extubation

Eligibility
Key inclusion criteria
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?
No
Key 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
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization - drawing envelope from a box containing equal number of envelopes for each group
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The quantitative data will be processed and analysed through the use of SPSS version 20. Descriptive and inferential statistic will be used. Repeated measure ANOVA will be used to compare the mean score of knowledge level between pre-test and post-test results. General Linear Model will be used to analyse the results of the patient outcomes between the control and intervention group.
Qualitative data that generated through focus group interview will analysed by creating a text-file to employ a sorting and classifying process. Content analysis will be applied to the transcribed comments.

We are planning a study of a continuous response variable from independent control and experimental subjects with 1 control(s) per experimental subject. In a previous study, the response within each subject group was normally distributed with standard deviation 0.2. If the true difference in the experimental and control means is 0.2 (20%), according to PS sample size calculation software, we will need to study 17 experimental subjects (using mechanical device) and 17 control subjects (traditional method using manual manometer) to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05. However, when we took into account the possibility of dropping of out of cases due to various factors, the number of patients to include was doubled, thus a minimum of 34 in each group.

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] 7827 0
Malaysia
State/province [1] 7827 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 293407 0
Commercial sector/Industry
Name [1] 293407 0
Tracoe Medical
Address [1] 293407 0
TRACOE medical GmbH, Reichelsheimer StraBe 1 / 3, 55268 Nieder-Olm
Country [1] 293407 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] 292234 0
Individual
Name [1] 292234 0
Dr. Vineya Rai
Address [1] 292234 0
Anaesthesiology and Intensive Care Unit, University Malaya Medical Centre. Lembah Pantai,59100. Kuala Lumpur
Country [1] 292234 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294994 0
Medical Ethics Committee, University Malaya Medical Centre
Ethics committee address [1] 294994 0
Lembah Pantai, 59100 Kuala Lumpur
Ethics committee country [1] 294994 0
Malaysia
Date submitted for ethics approval [1] 294994 0
05/02/2016
Approval date [1] 294994 0
17/02/2016
Ethics approval number [1] 294994 0
20162-2155

Summary
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)

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65194 0
A/Prof Vineya Rai a/l Hakumat Rai
Address 65194 0
University Malaya Medical Centre,
Lembah Pantai, 59100 Kuala Lumpur
Country 65194 0
Malaysia
Phone 65194 0
+603 79494422
Fax 65194 0
Email 65194 0
vineyarai@ummc.edu.my
Contact person for public queries
Name 65195 0
A/Prof Vineya Rai a/l Hakumat Rai
Address 65195 0
University Malaya Medical Centre,
Lembah Pantai, 59100 Kuala Lumpur
Country 65195 0
Malaysia
Phone 65195 0
+603 79494422
Fax 65195 0
Email 65195 0
vineyarai@ummc.edu.my
Contact person for scientific queries
Name 65196 0
A/Prof Vineya Rai a/l Hakumat Rai
Address 65196 0
University Malaya Medical Centre,
Lembah Pantai, 59100 Kuala Lumpur
Country 65196 0
Malaysia
Phone 65196 0
+603 79494422
Fax 65196 0
Email 65196 0
vineyarai@ummc.edu.my

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