Assessing patient-ventilator interaction for patients with respiratory failure

• Register: ANZCTR
• Last refreshed on: 20 September 2021
• Main ID: ACTRN12618000468224
• Date of registration: 29/03/2018
• Prospective Registration: No
• Primary sponsor: Monash University Malaysia
• 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)
• Date of first enrolment: 29/08/2017
• Target sample size: 60
• Recruitment status: Stopped early
• URL: https://anzctr.org.au/ACTRN12618000468224.aspx
• Study type: Observational
• Study design: Purpose: Screening;Duration: Cross-sectional;Selection: Defined population;Timing: Both;
• Phase: Not Applicable

Countries of recruitment

Malaysia

Contacts

• Name: A/Prof Mohd Basri Mat Nor

• Name: Dr Chiew Yeong Shiong

Key inclusion & exclusion criteria

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.

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.


Age minimum: 16 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

respiratory failure;
respiratory failure

Respiratory - Other respiratory disorders / diseases

Intervention(s)

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

Primary Outcome(s)

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[Continuous recording from the ventilator/ airway pressure and flow during invasive mechanical ventilation, 72 hours from screening.]

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%
[Continuous recording from the ventilator/ airway pressure and flow during invasive mechanical ventilation, 72 hours from screening.]

Secondary Outcome(s)

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

[Continuous recording from the ventilator/ airway pressure and flow during invasive mechanical ventilation, 72 hours from screening.]

Secondary ID(s)

None

Source(s) of Monetary Support

Ministry of Higher Education (MOHE) Malaysia

Secondary Sponsor(s)

IIUM Medical Centre - International Islamic University Malaysia

Ethics review

Status: Approved
Approval date: 12/01/2017
Contact:

IIUM Research Ethics Commitee (IREC)

Results

• Results available: Yes
• Date Posted: 05/03/2020
• Date Completed: 06/02/2020