Trial Review

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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
Date results information 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] 292324 0
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 303877 0
Condition category
Condition code
Anaesthesiology 303232 303232 0 0
Anaesthetics
Respiratory 303233 303233 0 0
Other respiratory disorders / diseases
Injuries and Accidents 303234 303234 0 0
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] 298551 0
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] 302619 0
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] 302619 0
24 hours post commencement of mechanical ventilation.
Secondary outcome [1] 336535 0
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] 336535 0
First 30 days of mechanical ventilation or intensive care length of stay (whichever occurs first).
Secondary outcome [2] 336536 0
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] 336536 0
24 hours post commencement of mechanical ventilation.
Secondary outcome [3] 336537 0
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] 336537 0
First 30 days of mechanical ventilation or intensive care length of stay (whichever occurs first).
Secondary outcome [4] 336538 0
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] 336538 0
First 30 days of mechanical ventilation or date of extubation (whichever occurs first).
Secondary outcome [5] 336719 0
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] 336719 0
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?
No
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] 8465 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 16549 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 296871 0
Hospital
Name [1] 296871 0
Liverpool Hospital
Country [1] 296871 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
7103 Locked Bag 7103
Liverpool BC NSW 2170
Country
Australia
Secondary sponsor category [1] 295879 0
University
Name [1] 295879 0
South Western Clinical School, University of New South Wales
Address [1] 295879 0
Goulburn St
Liverpool NSW 2170
Country [1] 295879 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298097 0
South Western Sydney Local Health District
Ethics committee address [1] 298097 0
Locked Bag 7279
Liverpool BC NSW 1871
Ethics committee country [1] 298097 0
Australia
Date submitted for ethics approval [1] 298097 0
20/06/2017
Approval date [1] 298097 0
12/07/2017
Ethics approval number [1] 298097 0
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] 1848 1848 0 0
/AnzctrAttachments/373230-EMERGENCY LUNG-PROTECTIVE VENTILATION IMPLEMENTATION STRATEGY v2.0.pdf (Protocol)
Attachments [2] 1849 1849 0 0
/AnzctrAttachments/373230-ELVIS CASE REPORT FORM.pdf (Other)

Contacts
Principal investigator
Name 75978 0
Dr Christopher Partyka
Address 75978 0
Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
Country 75978 0
Australia
Phone 75978 0
+61287383950
Fax 75978 0
+61287383984
Email 75978 0
[email protected]
Contact person for public queries
Name 75979 0
Dr Christopher Partyka
Address 75979 0
Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
Country 75979 0
Australia
Phone 75979 0
+61287383950
Fax 75979 0
+61287383984
Email 75979 0
[email protected]
Contact person for scientific queries
Name 75980 0
Dr Christopher Partyka
Address 75980 0
Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
Country 75980 0
Australia
Phone 75980 0
+61287383950
Fax 75980 0
+61287383984
Email 75980 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified patient data (individual participant data of published results only)
When will data be available (start and end dates)?
Once data analysis complete
No end date determined.
Available to whom?
Interested parties with Ethics approved protocols
Available for what types of analyses?
Research relating to lung-protective ventilation.
How or where can data be obtained?
Via PI (using details in ANZCTR registration)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5847Study protocol  [email protected] 373230-(Uploaded-14-11-2019-12-24-21)-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.