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Trial registered on ANZCTR


Registration number
ACTRN12623001251617
Ethics application status
Approved
Date submitted
9/11/2023
Date registered
4/12/2023
Date last updated
26/08/2024
Date data sharing statement initially provided
4/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Multi-centre Observational study of Supportive Ventilation Adjustments and Respiratory Effort Parameters in Adult Patients Admitted to the Intensive Care Unit
Scientific title
An Audit of Supportive Ventilation Adjustments and Respiratory Effort Parameters in Adults Admitted to the Intensive Care Unit
Secondary ID [1] 310927 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mechanical ventilation 331988 0
Condition category
Condition code
Respiratory 328730 328730 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
Twice daily auditing between 08:00-10:00 and 16:00-18:00 to identify mechanically ventilated patients in spontaneous ventilation modes, in order to observe clinicians as they adjust the level of pressure support to optimise respiratory rate and tidal volume, typically applying the usual rates of 5, 10 or 15 cm of H2O of pressure support and observing the changes in respiratory rate and tidal volume. Observations will be undertaken twice daily for a maximum of seven consecutive days by study team members. Clinicians will be informed of the observations and the ventilation management of patients will remain at the discretion of the treating clinicians.
Intervention code [1] 327355 0
Early Detection / Screening
Comparator / control treatment
Clinicians are responsible for the care and ventilation decisions of adult patients who are admitted to the intensive care unit and can adjust pressure support without auditing.
Control group
Active

Outcomes
Primary outcome [1] 336540 0
P0.1, where P0.1 is the measured drop in airway pressure in the first 100 milliseconds of a patient’s inspiratory effort.
Timepoint [1] 336540 0
Twice daily assessment between the periods of 08:00-10:00 and 16:00-18:00 as obtained from the ventilator's measured parameters for a maximum of seven consecutive days while the patient is admitted to the intensive care unit.
Secondary outcome [1] 428739 0
PMI, where PMI is the difference between the airway pressure at the end of inspiration. This is calculated by the ventilator as positive end expiratory pressure [PEEP] + Pressure support level administered (abbreviated to Ppeak) minus plateau airway pressure (abbreviated to Pplat) after the peak pressure has dissipated (in short: Ppeak – Pplat).
Timepoint [1] 428739 0
Twice daily assessment between the periods of 08:00-10:00 and 16:00-18:00 as obtained from the ventilator's measured parameters for a maximum of seven consecutive days while the patient is admitted to the intensive care unit.
Secondary outcome [2] 428740 0
DPocc, where DPocc is the difference between the Pplat and PEEP. This pressure reflects the elastic workload of the patient’s respiratory system
Timepoint [2] 428740 0
Twice daily assessment between the periods of 08:00-10:00 and 16:00-18:00 as obtained from the ventilator's measured parameters for a maximum of seven consecutive days while the patient is admitted to the intensive care unit.

Eligibility
Key inclusion criteria
All adult patients requiring mechanical ventilation in a spontaneous ventilation mode while admitted to the intensive care unit as identified during the twice daily screening periods.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All adult patients requiring mechanical ventilation who are not in a spontaneous ventilation mode while admitted to the intensive care unit as identified during the twice daily screening periods.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
A single interim analysis will be performed after 50 patients have been enrolled. The purpose of this interim analysis is to check for potential safety issues as well as assess early efficacy.

At the end of the audit period all data will be collected and analysed. Analytical procedures will include descriptive statistics, analysis of variance, logistic and linear regression modelling. In particular, “R” software, version 3.5.2 (The R Foundation for Statistical Computing, Vienna, Austria) will be used for analysis.

We will conduct comparative assessments (e.g., afternoon vs. morning values) using the Mann-Whitney test. We will report continuous data as medians [interquartile range]. Longitudinal ventilator-related variables will be analysed using linear mixed effects models, accounting for within subject repeated measures, and treating time as a continuous variable.

We will assess the impact of different levels of pressure support on the key parameters of respiratory effort (P0.1, PMI, DPocc) by conducting a multivariable model, which will include patient characteristics and an interaction test for study centre. We will consider a P value below 0.05 as significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/12/2023
Actual
5/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25825 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 25826 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [3] 25827 0
The Alfred - Melbourne
Recruitment hospital [4] 26998 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 41652 0
3084 - Heidelberg
Recruitment postcode(s) [2] 41653 0
3168 - Clayton
Recruitment postcode(s) [3] 41654 0
3004 - Melbourne
Recruitment postcode(s) [4] 43072 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 315187 0
Hospital
Name [1] 315187 0
Austin Health
Country [1] 315187 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 317216 0
None
Name [1] 317216 0
None
Address [1] 317216 0
Country [1] 317216 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314118 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 314118 0
145 Studley Road Heidelberg VIC 3084
Ethics committee country [1] 314118 0
Australia
Date submitted for ethics approval [1] 314118 0
14/08/2023
Approval date [1] 314118 0
20/09/2023
Ethics approval number [1] 314118 0

Summary
Brief summary
Many patients admitted to the intensive care unit (ICU) for on-going clinical management receive breathing assistance with machines (mechanical ventilation). Mechanical ventilation is the process by which a patient’s breathing is supported by a ventilator. Broadly speaking there are two modes of breathing: i) Mandatory and ii) Supportive. Mandatory ventilation is used when the clinicians deem it necessary to control all aspects of breathing. Supportive ventilation is used when the clinicians aim to help the patient’s spontaneous breathing with some adjusted machine assistance. While receiving mechanical ventilation the patient’s intensive care clinicians make clinical decisions about their patient’s breathing. Such decisions relate to the amount of oxygen to provide, the number and depth of breaths, how much force is needed to adequately inflate the lungs and importantly when it is suitable to wake the patient and remove the breathing tube. All these decisions can be defined as the ventilation management of the critically ill patient receiving mechanical ventilation.

For critically ill patients, changes in ventilation support are often made based breathing rate (respiratory rate) and size of breaths (tidal volume). However, the effect these changes have on measurable aspects of breathing effort (which define breathing work) remain unclear. Importantly, such information, which was difficult to get in the past, can now be obtained from modern ventilators just by pushing a button or moving a cursor on the screen. Such information is then displayed on the ventilator screen.

In response, we will perform a prospective observational study of supportive ventilation settings in patients who are receiving supportive mechanical ventilation in the intensive care unit. In this multi-centre study, we estimate that the information obtained from 30-35 patients per site (4 sites) will lead to approximately 600 ventilation data-points collected from a cohort of 100 patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130470 0
Prof Rinaldo Bellomo
Address 130470 0
Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
Country 130470 0
Australia
Phone 130470 0
+61394965992
Fax 130470 0
+61394963932
Email 130470 0
[email protected]
Contact person for public queries
Name 130471 0
Rinaldo Bellomo
Address 130471 0
Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
Country 130471 0
Australia
Phone 130471 0
+61394965992
Fax 130471 0
+61394963932
Email 130471 0
[email protected]
Contact person for scientific queries
Name 130472 0
Rinaldo Bellomo
Address 130472 0
Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
Country 130472 0
Australia
Phone 130472 0
+61394965992
Fax 130472 0
+61394963932
Email 130472 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
Observational data is considered hypothesis-generating.


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.