ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12617001005347

Ethics application status

Approved

Date submitted

30/06/2017

Date registered

12/07/2017

Date last updated

25/11/2019

Date data sharing statement initially provided

25/11/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

The Emergency Lung-Protective Ventilation Implementation Strategy (ELVIS) for mechanically-ventilated patients in the emergency department: a before and after study.

Scientific title

The Emergency Lung-Protective Ventilation Implementation Strategy (ELVIS) project for mechanically-ventilated patients in the emergency department: a before and after study to compare ventilation parameters, pulmonary complications and clinical outcomes.

Secondary ID [1]

None.

Universal Trial Number (UTN)

n/a.

Trial acronym

The ELVIS Project

Linked study record

n/a.

Health condition

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

Mechanical ventilation

Condition category

Condition code

Anaesthesiology

Anaesthetics

Respiratory

Other respiratory disorders / diseases

Injuries and Accidents

Other injuries and accidents

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

The Emergency Lung-protective Ventilation Implementation Strategy guideline aims to standardise the mechanical ventilation of intubated Emergency Department patients in a metropolitan tertiary referral hospital. The guideline encourages accurate calculation of 'ideal body weight' (IBW) through measurement of patient height & aims to ventilate patients at 6-8mL/kg of IBW, whilst maintaining a plateau pressure of less than 30cmH2O. It also mandates prescribed ventilation & oxygenation targets empowering bedside nursing staff to adjust ventilator settings or seek early medical assistance in providing finessed, patient-specific, lung-protective ventilation.

It is a quality improvement initiative designed by Emergency Medicine and Intensive Care physicians and approved for implementation by Executive members of both departments.

ELVIS will be introduced as a quality improvement initiative to senior medical staff (specialist Emergency Physicians and senior registrars), Clinical Nurse Educators and resus- trained nurses via formal in-services. Implementation will take place once 75% of these staff have been educated and signed off for use.

Following the implementation of ELVIS, all patients aged greater than or equal to 16 years, who are mechanically ventilated in emergency department (with the exception of those excluded by clinician discretion, eg. life-threatening asthma) will have their ventilation strategy optimised by the ELVIS guideline. Prospective data will be collected on all mechanically ventilated patients for one year following implementation to ensure quality improvement outcomes are being reached.

Intervention code [1]

Not applicable

Comparator / control treatment

This is a before and after observational study. The comparator group in this trial is the cohort of intubated and mechanically ventilated patients treated in the same facility over the prior two years (2015-2016), before ELVIS implementation.

Control group

Historical

Outcomes

Primary outcome [1]

To measure the percentage of mechanically ventilated patients who receive a lung protective strategy (tidal volumes of 6-8mL/kg of IBW whilst maintaining a plateau pressure of less than 30cmH2O) in the emergency department following implementation of the ELVIS guideline and compare this to rates of lung protective ventilation that occurred prior to this implementation (by review of medical records).

Timepoint [1]

24 hours post commencement of mechanical ventilation.

Secondary outcome [1]

To measure the percentage of patients receiving lung-protective ventilation who develop pulmonary complications (eg. atelectasis, pneumothorax or ventilator-associated pneumonia) during their hospital stay, and compare this to rates that occurred prior to this implementation (by review of medical records and radiology reports).

Timepoint [1]

First 30 days of mechanical ventilation or intensive care length of stay (whichever occurs first).

Secondary outcome [2]

To measure the percentage of patients receiving lung-protective ventilation who reach their predetermined physiological targets (oxygenation and ventilation) (by review of medical records).

Timepoint [2]

24 hours post commencement of mechanical ventilation.

Secondary outcome [3]

To measure the percentage of patients receiving lung-protective ventilation who reach acute lung injury or acute respiratory distress syndrome criteria during their hospital stay, and compare this to rates that occurred prior to this implementation (by review of medical records and radiology reports).

Timepoint [3]

First 30 days of mechanical ventilation or intensive care length of stay (whichever occurs first).

Secondary outcome [4]

To measure the total ventilator days in patients receiving lung-protective ventilation and compare this to durations that occurred prior to this implementation (by review of medical records).

Timepoint [4]

First 30 days of mechanical ventilation or date of extubation (whichever occurs first).

Secondary outcome [5]

To measure the hospital length of stay in patients receiving lung- protective ventilation and compare this to durations that occurred prior to this implementation (by review of medical records).

Timepoint [5]

Date of hospital discharge or one year from admission date (whichever occurs first).

Eligibility

Key inclusion criteria

Mechanically ventilated patients (including those intubated prehospital).
Age greater than or equal to 16 years.

Minimum age

16 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Age less than 16 years
2. Underlying clinical condition or lung pathology not conducive to lung-protective ventilation (at discretion of treating physician).

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Both

Statistical methods / analysis

Following a twelve month trial period, clinical data will be formally reviewed to establish the effectiveness of this strategy including patient demographics, intubation details, physiological observations, ventilation parameters, blood gas results and rates of ventilator-associated pneumonia and acute lung injury. This data will be collated and compared to our current, pre-ELVIS ventilation practices (2015-16 data).

All analyses will be supervised by a senior biostatistician.

Normally distributed outcomes will be reported as means (SD) and non-normal data will be reported as medians (IQR). Categorical data will be reported as count and proportions. A two-sided p-value of 0.05 will be considered statistically significant. Multivariable logistic regression with propensity score adjustment will test the hypothesis that ED lung-protective ventilation decreases the incidence of pulmonary complications.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

7/08/2017

Actual

1/08/2017

Date of last participant enrolment

Anticipated

31/07/2018

Actual

1/08/2018

Date of last data collection

Anticipated

1/12/2018

Actual

10/12/2018

Sample size

Target

250

Accrual to date

Final

700

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Liverpool Hospital - Liverpool

Recruitment postcode(s) [1]

2170 - Liverpool

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Liverpool Hospital

Address [1]

7103 Locked Bag 7103 Liverpool BC NSW 2170

Country [1]

Australia

Primary sponsor type

Hospital

Name

Liverpool Hospital

Address

7103 Locked Bag 7103
Liverpool BC NSW 2170

Country

Australia

Secondary sponsor category [1]

University

Name [1]

South Western Clinical School, University of New South Wales

Address [1]

Goulburn St Liverpool NSW 2170

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Western Sydney Local Health District

Ethics committee address [1]

Locked Bag 7279
Liverpool BC NSW 1871

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/06/2017

Approval date [1]

12/07/2017

Ethics approval number [1]

AU/7/EC0E215

Summary

Brief summary

A small number of patients who are brought to the emergency department need a general anaesthetic. This lets us help them by keeping their airway open, improve their oxygen levels and breathe for them on a mechanical ventilator. Some of these patients have injured or severely diseased lungs. In these patients, a protective ventilator setting (small volumes of breath at lower pressures) reduces rates of death and time on a ventilator. Other patients have normal lungs initially, but are at risk of developing lung disease whilst on a ventilator. The use of the same protective ventilator settings on these patients can reduce the development of severe lung disease, including infections and lung collapse.

Currently, the ventilator settings in our emergency department are set by the bedside, treating clinician. These may not always be with protective settings.

We aim to improve the quality of our care of our ventilated patients by optimising ventilator settings and increasing the frequency by which protective settings are used. This will be done by implementing a guideline (called ELVIS) designed to prompt clinicians and bed-side nursing staff to set the ventilator to patient-specific, protective values whilst promoting frequent reassessment of these targets and adjusting settings on a regular basis to meet the patients needs. This guideline has been developed by both Intensive Care and Emergency Medicine specialists.

The ELVIS guideline will be used on all ventilated patients in the emergency department, unless the clinician believes an alternate method is safer based on their underlying lung disease. For example, asthmatic patients do not need a protective strategy and will not have the guideline used.

Most ventilated patients are transferred from the emergency department to the intensive care unit. These protective ventilator settings will be continued in intensive care.

This study aims to compare clinical data, ventilation settings and outcomes of patients ventilated according to the ELVIS guideline to those who were ventilated during the subsequent two years (2015-2016).

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/373230-EMERGENCY LUNG-PROTECTIVE VENTILATION IMPLEMENTATION STRATEGY v2.0.pdf (Protocol)

Attachments [2]

/AnzctrAttachments/373230-ELVIS CASE REPORT FORM.pdf (Other)

Contacts

Principal investigator

Name

Dr Christopher Partyka

Address

Liverpool Hospital Locked Bag 7103 Liverpool BC NSW 1871

Country

Australia

Phone

+61287383950

Fax

+61287383984

[email protected]

Contact person for public queries

Name

Christopher Partyka

Address

Liverpool Hospital Locked Bag 7103 Liverpool BC NSW 1871

Country

Australia

Phone

+61287383950

Fax

+61287383984

[email protected]

Contact person for scientific queries

Name

Christopher Partyka

Address

Liverpool Hospital Locked Bag 7103 Liverpool BC NSW 1871

Country

Australia

Phone

+61287383950

Fax

+61287383984

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Interested parties with Ethics approved protocols

Conditions for requesting access:
• -

What individual participant data might be shared?

• De-identified patient data (individual participant data of published results only)

What types of analyses could be done with individual participant data?

• Research relating to lung-protective ventilation.

When can requests for individual participant data be made (start and end dates)?

From:
Once data analysis complete
No end date determined.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Via PI (using details in ANZCTR registration)

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5847	Study protocol			[email protected]		Study-related document.pdf

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.

Trial Review

Documents added manually

Documents added automatically