Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001619831
Ethics application status
Approved
Date submitted
1/02/2021
Date registered
26/11/2021
Date last updated
22/11/2022
Date data sharing statement initially provided
26/11/2021
Date results information initially provided
22/11/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical Application of Respiratory Elastance for Virtual Model development (CARE02)
Scientific title
Clinical Application of Respiratory Elastance for virtual model development in patients with respiratory failure requiring mechanical ventilation (CARE02)
Secondary ID [1] 303228 0
None
Universal Trial Number (UTN)
U1111-1264-0551
Trial acronym
CARE02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory failure 320449 0
Condition category
Condition code
Respiratory 318340 318340 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 up to 30 patients. 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. Consent from legally-accepted representative will be obtained.

Data collection and clinical protocol
All patients enrolled are to be ventilated using Puritan Bennett PB980 ventilator (Covidien, Boulder, CO, USA). The mechanical ventilation airway pressure and flow of the patients will be collected using a data acquisition device developed by the investigators.
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 up to 7 days.
3. After 7 days, the data collection is stopped.

The following data, subject to availability are collected from the patient recruited into the observational trial. These data will be collected from the hospital record of the patient.
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.
7. Mechanical ventilation airway pressure and flow.
8. Fraction of Inspired oxygen.
9. Patient datasheet and arterial blood gases information.
Intervention code [1] 319563 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326307 0
To study the patient-ventilator interaction using a developed asynchrony detection algorithm. Patient-ventilator interaction is described using Asynchrony Index (AI). As this is is an observational trial, Aysnchrony index is calculated as the number of identified asynchronous breath over the total breath being analysed X 100%
Timepoint [1] 326307 0
Continuous recording from the ventilator/ airway pressure and flow during invasive mechanical ventilation from baseline to 7 days post-enrolment
Primary outcome [2] 326308 0
To investigate mechanically ventilated respiratory failure patient respiratory mechanics. Respiratory mechanics can be calculated using the lung models with airway pressure and flow waveform from the ventilator.
Timepoint [2] 326308 0
Continuous recording from the ventilator/ airway pressure and flow during invasive mechanical ventilation until the patient is disconnected from the ventilator, or up to 7 days post-enrolment.
Primary outcome [3] 328807 0
To investigate mechanically ventilated respiratory failure patient hemodynamic behaviour.
Timepoint [3] 328807 0
The hemodynamic behaviour can be collected from the patient daily chart from enrolment until the patient is disconnected from the ventilator, or up to 7 days post-enrolment.
Secondary outcome [1] 400452 0
To investigate the change of mechanical ventilator settings. in mechanically ventilated respiratory failure patient
Timepoint [1] 400452 0
Continuous recording from the ventilator/ airway pressure and flow during invasive mechanical ventilation until the patient is disconnected from the ventilator, or up to 7 days post-enrolment.

Eligibility
Key inclusion criteria
1. Patients requiring invasive mechanical ventilation (MV) (Intubation or tracheotomy).
2. Patients with PF [partial pressure of oxygen 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 than 16.
3. Any medical condition associated with a clinical suspicion of raised intracranial pressure and/or a measured intracranial pressure equal or more than 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 > 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
Completed
Date of first participant enrolment
Anticipated
Actual
6/04/2021
Date of last participant enrolment
Anticipated
9/02/2023
Actual
12/02/2022
Date of last data collection
Anticipated
16/02/2023
Actual
17/02/2022
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 23407 0
Malaysia
State/province [1] 23407 0
Pahang

Funding & Sponsors
Funding source category [1] 307635 0
Government body
Name [1] 307635 0
Ministry of Higher Education (MOHE) Malaysia
Country [1] 307635 0
Malaysia
Funding source category [2] 307671 0
Government body
Name [2] 307671 0
Ministry of Science, Technology and Innovation
Country [2] 307671 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] 308320 0
Hospital
Name [1] 308320 0
IIUM Medical Centre - International Islamic University Malaysia
Address [1] 308320 0
IUM Medical Centre International Islamic University Malaysia Jalan Sultan Haji Ahmad Shah, Bandar Indera Mahkota, 25200 Kuantan, Pahang,
Country [1] 308320 0
Malaysia
Other collaborator category [1] 281621 0
University
Name [1] 281621 0
Universiti Teknologi Mara
Address [1] 281621 0
Kampung Tok Ebot, 14000 Bukit Mertajam, Penang
Country [1] 281621 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307677 0
IIUM Research Ethics Commitee (IREC)
Ethics committee address [1] 307677 0
IIUM Research Ethics Committee (IREC) Research Management Center (RMC), Kuantan Campus, International Islamic University Malaysia Jalan Sultan Ahmad Shah, Bandar Indera Mahkota, 25200 Kuantan, Pahang
Ethics committee country [1] 307677 0
Malaysia
Date submitted for ethics approval [1] 307677 0
12/08/2020
Approval date [1] 307677 0
04/09/2020
Ethics approval number [1] 307677 0
IREC 2020-100

Summary
Brief summary
There has been an emerging interest to guide patient-specific Mechanical Ventilation (MV treatment through model-based approaches. These model-based methods are capable of estimating patient-specific respiratory mechanics, providing clinically useful information to the clinicians to guide MV treatment. Various model-based methods have been studied to aid clinical MV decision making. However, to date, the application of these model-based methods is limited in the clinical environment. In particular, there is little clinical trial evidence supporting the efficacy of these methods.

Model-based methods require specific clinical protocols and they can be hard to implement in actual clinical practice. In particular, these protocols may be invasive and potentially harmful. These specific clinical protocols can also affect patients' respiratory mechanics. As a result, there is a lack of clinical patient data to validate the performance of model-based methods. These data are unable to provide the wide information spectrum that is required to investigate the performance of model-based methods. Thus, there is a need for a mechanical ventilation patient database that can be used to investigate the clinical feasibility and efficacy of these model-based methods for MV treatment. To this end, a clinical observation trial is required to recruit MV respiratory failure patients. A data acquisition system will be used to collect MV data automatically when patients have been recruited and consented to the MV trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108102 0
A/Prof Mohd Basri Mat Nor
Address 108102 0
Kulliyyah of Medicine, International Islamic University Malaysia, Bandar Indera Mahkota Campus, Jalan Sultan Ahmad Shah, 25200 Kuantan, Pahang Darul Makmur.
Country 108102 0
Malaysia
Phone 108102 0
+6095704672
Fax 108102 0
Email 108102 0
m.basri@iium.edu.my
Contact person for public queries
Name 108103 0
A/Prof Mohd Basri Mat Nor
Address 108103 0
Kulliyyah of Medicine, International Islamic University Malaysia, Bandar Indera Mahkota Campus, Jalan Sultan Ahmad Shah, 25200 Kuantan, Pahang Darul Makmur.
Country 108103 0
Malaysia
Phone 108103 0
+6095704672
Fax 108103 0
Email 108103 0
m.basri@iium.edu.my
Contact person for scientific queries
Name 108104 0
Dr Chiew Yeong Shiong
Address 108104 0
Monash University Malaysia Jalan Lagoon Selatan, Bandar Sunway, 47500 Subang Jaya, Selangor
Country 108104 0
Malaysia
Phone 108104 0
+60355144985
Fax 108104 0
Email 108104 0
chiew.yeong.shiong@monash.edu

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.