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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Mechanical ventilation

Condition category

Condition code

Respiratory

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]

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]

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]

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]

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]

Secondary outcome [2]

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]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [2]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [3]

The Alfred - Melbourne

Recruitment hospital [4]

Cabrini Hospital - Malvern - Malvern

Recruitment postcode(s) [1]

3084 - Heidelberg

Recruitment postcode(s) [2]

3168 - Clayton

Recruitment postcode(s) [3]

3004 - Melbourne

Recruitment postcode(s) [4]

3144 - Malvern

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Health

Address [1]

145 Studley Road Heidelberg VIC 3084

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

145 Studley Road Heidelberg VIC 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

145 Studley Road Heidelberg VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/08/2023

Approval date [1]

20/09/2023

Ethics approval number [1]

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

Prof Rinaldo Bellomo

Address

Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084

Country

Australia

Phone

+61394965992

Fax

+61394963932

[email protected]

Contact person for public queries

Name

Rinaldo Bellomo

Address

Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084

Country

Australia

Phone

+61394965992

Fax

+61394963932

[email protected]

Contact person for scientific queries

Name

Rinaldo Bellomo

Address

Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084

Country

Australia

Phone

+61394965992

Fax

+61394963932

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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