Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000468224
Ethics application status
Approved
Date submitted
1/12/2017
Date registered
29/03/2018
Date last updated
15/09/2021
Date data sharing statement initially provided
5/03/2020
Date results information initially provided
5/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing patient-ventilator interaction for patients with respiratory failure
Scientific title
Clinical Application of REspiratory models in monitoring patient-ventilator interaction (CARE Study)
Secondary ID [1] 293488 0
None
Universal Trial Number (UTN)
U1111-1197-8785
Trial acronym
CARE Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
respiratory failure 305675 0
Condition category
Condition code
Respiratory 304896 304896 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This trial is an observational trial to recruit 60 patients in two years (30 patients per year). All patients admitted to the intensive care unit (ICU) at the IIUM Medical Centre, Malaysia during the study period will be screened for inclusion into the study.

Approval from ethical committee will be obtained. New patients will be screened for inclusion to the study. Consent from legally-accepted representative will be obtained. All patients admitted to the ICU during the study period will be screened.

Data collection and clinical protocol
All patients enrolled are to be ventilated using Puritan Bennett PB980 ventilator (Covidien, Boulder, CO, USA). Data collection will be performed using a CURE soft system. This system records the mechanical ventilation data from the Puritan Bennet ventilator 980.

1. The mechanical ventilator settings were not set and will vary depending on attending clinicians.
2. For each patient, the data will be collected for 72 hours.
3. After 72 hours, the data collection is stopped.

The following data are collected from the patient recruited into the observational trial.
1. Patient gender, height, weight and ethnicity.
2. Patient APACHE III diagnostic code.
3. Primary patient diagnosis contributing to respiratory failure
4. Secondary patient diagnosis contributing to respiratory failure
5. Relevant past medical history e.g. smoking, medication, cardiovascular disease.
6. Chest X-ray score: Murray Index (Murray et al., 1988) if available.
7. Mechanical ventilation airway pressure and flow
8. Fraction of Inspired oxygen
9. Patient data sheet and arterial blood gases information
Intervention code [1] 299727 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304086 0
Asynchrony Index (AI).

*As this is is an observational trial, Aysnchrony index is calculated as from the airway pressure and flow waveform that are identified as asynchronous. Aysnchrony index is calculated as the number of identified asynchronous breath over the total breath being analysed X 100%
Timepoint [1] 304086 0
Continuous recording from the ventilator/ airway pressure and flow during invasive mechanical ventilation, 72 hours from screening.
Primary outcome [2] 304724 0
Magnitude of asynchronous breathing.

*As this is is an observational trial, The magnitude of Asynchrony is calculated as from the airway pressure and flow waveform when compared to none asychronous breath.

The formulation is new and one of the calculation method can be found in https://www.sciencedirect.com/science/article/pii/S0169260717309938
Timepoint [2] 304724 0
Continuous recording from the ventilator/ airway pressure and flow during invasive mechanical ventilation, 72 hours from screening.
Secondary outcome [1] 340911 0
Respiratory mechanics of the patient during mechanical ventilation. (This outcome is to be calculated from model, not collected from data).

*There are 2 respiratory mechanics that we are looking out on 1) respiratory system elastance (E) and 2) respiratory system resistance (R). These 2 respiratory mechancics can be calculated from model using airway pressure and flow waveform from the ventilator. Method of calculation can be found in https://www.ncbi.nlm.nih.gov/pubmed/28435689
Timepoint [1] 340911 0
Continuous recording from the ventilator/ airway pressure and flow during invasive mechanical ventilation, 72 hours from screening.

Eligibility
Key inclusion criteria
1. Patients requiring invasive mechanical ventilation (MV) (Intubation or tracheotomy).
2. Patients with PF [oxygen partial pressure to fraction of inspired oxygen] ratio < 300 mmHg) .
3. Arterial line in situ.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who are likely to be discontinued from MV within 24 hours.
2. Patients with age less or equal to 16.
3. Any medical condition associated with a clinical suspicion of raised intracranial pressure and/or a measured intracranial pressure more or equal to 20 cmH2O.
4. Patients who have a high spinal cord injury with loss of motor function and/ or have significant weakness from any neurological disease.
5. Patients who are moribund and/or not expected to survive for less than 72 hours.
6. Lack of clinical equipoise by intensive care unit (ICU) medical staff managing the patient.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
We have sufficient samples for this observational trial.
Date of first participant enrolment
Anticipated
Actual
29/08/2017
Date of last participant enrolment
Anticipated
24/07/2019
Actual
4/02/2020
Date of last data collection
Anticipated
31/03/2020
Actual
6/02/2020
Sample size
Target
60
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 9401 0
Malaysia
State/province [1] 9401 0
Pahang

Funding & Sponsors
Funding source category [1] 296766 0
Government body
Name [1] 296766 0
Ministry of Higher Education (MOHE) Malaysia
Country [1] 296766 0
Malaysia
Primary sponsor type
University
Name
Monash University Malaysia
Address
Monash University Malaysia
Jalan Lagoon Selatan,
Bandar Sunway,
47500 Subang Jaya,
Selangor
Country
Malaysia
Secondary sponsor category [1] 295754 0
Hospital
Name [1] 295754 0
IIUM Medical Centre - International Islamic University Malaysia
Address [1] 295754 0
IIUM Medical Centre
International Islamic University Malaysia
Jalan Sultan Haji Ahmad Shah, Bandar Indera Mahkota,
25200 Kuantan, Pahang Darul Makmu
Country [1] 295754 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297994 0
IIUM Research Ethics Commitee (IREC)
Ethics committee address [1] 297994 0
IIUM Research Ethics Committee (IREC)
Research Management Center (RMC), Kuantan Campus
Level 1, Administrative Building (OCD),
International Islamic University Malaysia
Jalan Sultan Ahmad Shah, Indera Mahkota,
25200 Kuantan, Pahang
Ethics committee country [1] 297994 0
Malaysia
Date submitted for ethics approval [1] 297994 0
Approval date [1] 297994 0
12/01/2017
Ethics approval number [1] 297994 0
IREC 666

Summary
Brief summary
Asynchronous events (AE) occur when the breathing of a patient undergoing mechanical ventilation is not synchronised with the support from the ventilator. Frequent occurrence of AEs results in poor patient-ventilator interaction, leading to an increase in work of breathing and potentially, other adverse effects. Such adverse effects include patient discomfort, increased need for sedation, increased length of mechanical ventilation, and potentially higher mortality. AEs can occur anytime during partially or fully controlled ventilation. However, it is more frequent during partially assisted modes where the patient is breathing spontaneously and the ventilator support is triggered by patient respiratory effort. AE is currently assessed retrospectively and there is a need to detect AE in real time. This study aims to investigate the quality of patient-ventilator interaction in a local hospital. Using patient specific airway pressure and flow data, we aim to develop mathematical models that can be used to detect AEs automatically in real time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75686 0
A/Prof Mohd Basri Mat Nor
Address 75686 0
Kulliyyah of Medicine,
International Islamic University Malaysia,
Bandar Indera Mahkota Campus,
Jalan Sultan Ahmad Shah,
25200 Kuantan,
Pahang Darul Makmur.
Country 75686 0
Malaysia
Phone 75686 0
+6095704672
Fax 75686 0
Email 75686 0
[email protected]
Contact person for public queries
Name 75687 0
A/Prof Mohd Basri Mat Nor
Address 75687 0
Kulliyyah of Medicine,
International Islamic University Malaysia,
Bandar Indera Mahkota Campus,
Jalan Sultan Ahmad Shah,
25200 Kuantan,
Pahang Darul Makmur.
Country 75687 0
Malaysia
Phone 75687 0
+6095704672
Fax 75687 0
Email 75687 0
[email protected]
Contact person for scientific queries
Name 75688 0
Dr Chiew Yeong Shiong
Address 75688 0
Monash University Malaysia
Jalan Lagoon Selatan,
Bandar Sunway,
47500 Subang Jaya,
Selangor
Country 75688 0
Malaysia
Phone 75688 0
+60355144985
Fax 75688 0
Email 75688 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
-


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.